Virtual Leadership Workshop—Virtually Perfect Leadership: Thriving in the New Normal

July 8–22, 2020, 12:00-1:00 PM ET – Join us for a three-part, live, online workshop series providing tools that will empower you to present a Virtually Perfect Presence, become a Virtually Perfect Communicator, and manage a Virtually Perfect Team in the new normal of conducting business during and after the COVID-19 pandemic.

techXpo Replay—Paperless Systems and Remote Monitoring: Keeping Trials Moving through COVID-19 and Beyond

This session will provide insights into how sites, sponsors, and CROs are rapidly adopting online systems to maintain an efficient and compliant process for data monitoring.

techXpo Replay—Remote Monitoring: Connecting Sites, Sponsors, and CROs to Drive Quality

Join this event to discover how Veeva is putting sites, sponsors, and CROs in a dramatically stronger position to respond to this crisis and improve clinical trials in the long term.

Webinar Replay: Creating a Diverse and Sustainable Clinical Research Workforce: Expert Insights and Industry Initiatives

This panel discussion, featuring ACRP’s Partners in Workforce Advancement (PWA) Executive Steering Council members will provide insights from leading experts on how to create a diverse and sustainable clinical research workforce.

techXpo Replay—Managing a Remote Workforce: Tips & Tricks During COVID-19

Join us for an informative session where we will discuss strategies to better manage your remote teams, while helping ensure efficient and effective clinical trial operations. We will share best practices on how to collaborate and implement new remote processes utilizing electronic resources from start-up to closeout.

techXpo Replay—Complion eRegulatory: Your Partner in Success

In this session, you will learn how partnering with Complion provides the top of the line technological tools and one-on-one advisory services you need to succeed. 

techXpo Replay—Remote Monitoring 101: Learn How Research Sites Are Turning on Remote Monitoring Today and Get a Glimpse of the Future

Learn how leading research centers are enabling remote monitoring for their studies today, and how you can get set up in three weeks or less for regulatory and source remote monitoring and remote access.

Entry-Level Knowledge Assessment

Whether you’re an emerging professional looking to demonstrate your foundational knowledge to prospective employers or an organizational leader looking for an efficient, effective way to vet new hires, ACRP’s new Entry-Level Knowledge Assessment (ELKA) is for you.

Webinar Replay: Impact of COVID-19 Pandemic in Clinical Trials: Considerations and Tools

Join us to review how clinical trial implementation is changing for research that was ongoing before the COVID-19 pandemic, and how sites and sponsors must prepare to face these challenging times.

Webinar Replay: FAQs for Sites During COVID-19

Join us for an FAQ session on how sites can ensure compliance through COVID-19 led by David Vulcano, Vice President, Research Compliance & Integrity for HCA Healthcare.

Webinar Replay: Part 2: iRECIST Workshop

iRECIST guidelines have been developed to capture this new response pattern. This presentation, Part 2 of the series, will consist of a workshop using hypothetical cases to determine iRECIST responses.

Webinar Replay: Harnessing the Power of Digital and Social Media to Drive Patient Recruitment

Learn about current trends in online marketing that can impact the ROI from your campaigns. Obtain a better understanding of the requirements needed to maximize your campaigns effectiveness.

Webinar Replay: Blueprint for Effective Communication & Best Practices Towards Clinical Trial Success: A Project Manager’s Guide

Managing a clinical trial requires deep understanding, a sharp vision, ability to adapt, disciplined effort, and unrelenting focus on achieving project goals. Implementation of best practices and effective communication techniques throughout the life of a study, as presented in this webinar, are key components to the success of your clinical project.

Webinar Replay: It’s in the Science: The Key Components to Building a Clinical Research Team

Join us for an interactive video webinar on the key components of building a clinical research team. Our panel will discuss shared best practices and current processes for building and communicating with dynamic teams including remote workers.

Webinar Replay: Part 1: iRECIST: New Guidelines for Oncology Tumor Assessment

iRECIST guidelines have been developed to capture this new response pattern. This presentation, Part 1 of 2 presentations, will introduce you to the history of the iRECIST guidelines, the iRECIST process and how iRECIST is being used in oncology clinical trials. Part 2 will consist of a workshop using hypothetical cases to determine iRECIST responses.

Webinar Replay: Multi-Center Investigator-Initiated Trial Guidance: The Best Practices of an Actual Multi-Center IIT

This presentation will focus on lessons learned from a recent observational study of 6 clinical research sites over the course of three years.

Webinar—R3: Recovery, Research, & Ramp-Up

June 9, 2020, 12:00-1:00 PM ET – Explore the considerations, processes, and procedures for research recovery and ramp-up related to COVID-19 and the impact it has had on research operation and administration.

techXpo—Partnering with Sponsors to Solve the Enrollment Problem

June 16, 2020, 12:00PM-1:00 PM ET: Join us to learn exactly how sponsors can operationalize strong partnerships with their sites and eliminate the traditional site/sponsor communication burden that plagues both sides.

techXpo—Is Your Site Ready for the “New Normal?” One Site’s Journey to Implementing New Technology for Remote Work and Increased Efficiency

June 18, 2020, 12:00-1:00 PM ET – Join Clinical.ly for an informative session centered around the COVID-19 paradigm shift as clinical research sites turn towards new technology to enhance their operations.

Webinar—Strategic Planning and Operational Efficiency: There’s a Difference But It Seems We’re Losing Sight of That

July 1, 2020, 12:00-1:00 PM ET – Learn strategies to ensure your company’s long term survival and growth in our industry’s competitive environment.

Webinar Replay: New Laws and Technology Standards That Will Transform Medical Research

New technology, laws, and consumer expectations are driving changes in Health IT that will impact every patient, health care provider, and researcher in the US. To be prepared for this change, it is vitally important to understand what is happening now and what is coming around the corner.

Webinar—Investigator Initiated Trial (IIT) Database Design and Build

August 19, 2020, 12:00 PM-1:00 PM ET: Join us for the first session in a two-part session to learn how to turn your protocol into a fully functional database, translate study objectives into data points that make it easier to manage and analyze your data, and clean and monitor data points throughout the course of the study.

Webinar—Investigator Initiated Trial (IIT) Database Integrity

August 26, 2020, 12:00 PM-1:00 PM ET: Join us for the second part of our presentation on building databases for an Investigator Initiated Trial (IIT).

Certified Quality Manager Training

Increase your influence and expand your career opportunities by validating your commitment to quality. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites.

• CRC, CRN, DMCTO, Investigator, MCRA, PR, PMs, RM, RTA

Webinar Replay: Finding the Right Recruitment Approach: A Discussion of One Organization’s Approach

Join us for a discussion on one of the most difficult tasks within clinical research. ACRP’s Editor-in-Chief, Michael Causey, will chat with Chris Gantz, Senior Director at Sidney Kimmel Cancer Center, about an approach that has been successful for him and his team.

Webinar Replay: Best of ACRP 2019 – Building Relationships & Collaboration: Sponsors and Sites

We invite all CRCs, CRAs, Project Managers, Regulatory Liaisons, and other study personnel to join this webinar for a review of our responsibilities and a discussion of these relationship. Feedback from high performing sites on strategies for collaboration and relationship building will be shared and open forum for discussion provided.

Webinar Replay: Best of ACRP 2019 – EFS is the new OUS strategy for early-phased medical device clinical trials

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions.

• Entry Level, Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Risk-Based Monitoring: The Essentials

Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?

• Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, PMs, QCS, RS, RTA, SSSU, Statistician, , Trainer

GCP for the Experienced Clinical Research Professional

Learn about today’s most common inspection findings and proven strategies to avoid them through correct application of the GCP guidelines.

Webinar Replay: Best of ACRP 2019 – Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective

This session will provide an overview on how to appropriately identify, document and address compliance issues noted at sites, from monitoring and Sponsor perspectives. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.

Webinar Replay: Best of ACRP 2019 – Inspection Readiness – Beginning with the End in Mind

The key to a successful inspection is preparing at the start of the study. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings

Webinar Replay: Best of ACRP 2019 – Effective Project Management to Streamline your Clinical Trial Workload

Providing clear and effective project management can make a successful clinical trial. Project planning and management are a part of achieving quality clinical data. This session will provide new and current Project Managers with useful tools to streamline their workload and hopefully decrease some of the common stress of the role.

Webinar Replay: Drug Development Process: A Review of ICH E8

Learn to describe internationally accepted principles and practices for the conduct of clinical trials and overall development strategy, facilitate the evaluation and acceptance of international trial data, and present an overview of ICH E8 other ICH guidelines pertinent to clinical trials.

Webinar Replay: Expressing Gratitude & Returning Aggregate Study Results to Participants—It’s the Right Thing to Do!

Thanking and returning results to study participants honors research volunteers, helps build trust in the clinical research process, and is simply the right thing to do! Join us for an engaging discussion on the benefits, methodology, and resources available to develop thank you cards and lay summaries of aggregate results in a language and format that is understandable and easy to read.

Webinar Replay: Best of ACRP 2019 – How to Create a Culture of Quality at a Research Site

Sites are so busy that quality assurance is often overlooked and only becomes a focus when issues arise or when there is an audit. We will describe our experience creating a culture of quality using an integrative approach in a team environment.

Webinar Replay: Identifying, Training and Retaining Investigators

How can we identify investigators, train them and all the while keep them engaged?

Webinar Replay: Defying Clinical Inertia and Improving Workflow with Measurement-Based Care Tool

Join co-Investigators as they share their experiences in conducting a pilot study on the role of Measurement Based Care (MBC) in improving mental health outcomes, its role in defying clinical inertia (the failure to change treatment plans despite the lack of improvement in symptom severity), and significance of a novel technology in the current healthcare system.

Webinar Replay: Establishing a High Quality Human Research Protection Program (HRPP) the AAHRPP Model

This presentation will look at opportunities for flexibility in human research protection programs that can facilitate research, including the notion that the resources devoted to the evaluation and management of research should be calibrated appropriately according to the risks posed by the research. In addition, the presentation will briefly consider some changes to the Common Rule and impacts on HRPPs.

Webinar Replay: A Beginner’s Guide to Implementing Competency Guidelines: Do’s and Don’ts to Set Your Institution Up for Success – Part One

ACRP and Huron Consulting Group joint two-part webinar replay, where we will discuss the theoretical aspects of a competency-based clinical research program, along with tactical considerations for implementation.

Webinar Replay: Adverse Event Reporting in Medical Device Studies: Managing/Assessing Events and Maintaining Compliance

This session will cover identifying, assessing, and reporting adverse events (AEs) for medical device studies at the site level. Webinar Replay expires July 31, 2020.

• Intermediate

The Impact of Disruptive Change in the Clinical Trials Industry on Research Sites

As we head towards the end of the second decade of the twenty-first century a great deal has changed about the way research is done at the site level particularly as it relates to the many disruptive technology driven changes that have evolved. Or has it? After 13 years managing sites and taking the investigator view followed by 13 years in the CRO industry taking the sponsor view, the author will look at what has changed in over a quarter of century and the future holds for clinical research sites. In particular he will look at the site landscape through the lens of four, supposedly major, disruptive changes.

• Senior

“You Want Me to Do WHAT?”: Building Lasting Sponsor/Site Relationships Part Deux

“Coming together is a beginning. Keeping together is progress. Working together is success.” – Henry Ford. How do you build a solid sponsor-site working relationship from site identification to closeout and beyond? This session was provided at ACRP 2018 and was requested to be brought back as it was a so insightful. The speakers for this session represent the sponsor and site perspective and will engage the attendees with an interactive session designed for all site and sponsor representatives to build on their effective communication strategies.

• Entry Level

Write Like an 8th Grader! Improving Readability in Clinical Research

How do you ensure that your clinical research materials are readable for the audiences you want to reach? This session will help you learn how to measure and improve the readability of your clinical research communications to a participant and public-facing audience. We will discuss the importance of readability and explore the pros and cons of tools you can use. Case examples from the Duke Clinical Research Institute including informed consent forms, recruitment materials, and lay summaries will highlight how to use free and existing resources to improve your communication.

• Intermediate

With Great Power Comes Great Responsibility: What to Consider in Conducting the Physician-Sponsored IDE

Physician-Sponsored IDE (PS-IDE) offers an ability for the physicians to design the study to treat patients with the unapproved medical devices without the industry support or oversight. The unapproved devices may be born out of physician’s innovation (new devices) or innovative practice such as using the commercially available devices for unapproved indication (i.e., off-label use) or customizing/modifying the approved devices (altered device is considered a new device). Although there is a lot of freedom for the physician to design and conduct his or her own PS-IDE study, it is important to understand the regulatory requirements in every aspect of the trial that you will be personally responsible for. The study site will also have a unique challenge as it must incorporate sponsor obligations into their practices.

• Intermediate

Who’s on First: Developing the Best Inspection Team

We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection “game plan” brings confidence to any inspection team.

• Senior

Vendor Management- Selecting, Budgeting, and Managing

This presentation will focus on selecting the best vendors for a specific study, including vendor costs in the study budget, and how to successfully collaborate with the vendors from startup to close out. (This session will not cover qualification of vendors.) I will review the most common types of vendors needed for clinical research studies, what information each type will request from the study sponsor, and how to develop vendor budgets. There will be a discussion on how to review vendor proposals to determine the best fit for the study. Once selected, I will review methods to ensure oversight of the vendor during the length of the study.

• Intermediate

US FDA Submission Process for Medical Devices

Regulatory submissions are a result of teamwork, often occurring over many years. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission. This session will take a step by step approach to walk attendees though what is required in the 510(k) and PMA submission process; and how you can best support the process. In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections. Participants of this session will get a broad appreciation of the submission process and some best practices to support your team in the regulatory submission process.

• Entry Level

Updates on Fraud, Waste, and Abuse in Clinical Research and the False Claims Act

Whistleblower Acts play an important role in detecting fraud, waste and abuse. A person who “knows” of fraud being committed against the government can file a lawsuit and, in some cases, receive a reward for bringing original information about a violation to the government’s attention. Because of the importance of the False Claims Acts in clinical research, this presentation will provide a primer on the Acts, address fraud enforcement trends and the various “hot button” issues in clinical research. It will also discuss how non-compliance compromises not only the financial and operational viability of current trials, but may result in a loss of funding, a risk of fines and penalties imposed by oversight agencies, settlement costs and/or damages arising from actions, and diminution of the organization’s reputation.

• Entry Level

Unveiling the Mystery of Quality Tolerance Limits

This session focuses on answering the questions of what quality tolerance limits (QTLs), risk indicators, and thresholds are by defining them and discussing how to establish them. We will look at examples of QTLs, risk indicators, and thresholds and discuss appropriate responses to breaches in the thresholds. In addition, documentation of breaches will be reviewed, reporting expectations and long-term plans for the QTLs, risk indicators, and thresholds. Key take-aways will include examples of QTLs, risk indicators, and thresholds to help one get started with establishing QTLs at their organization.

• Intermediate

Tools for Advancing Patient-Centered Medical Device Clinical Trials

Industry, FDA and patient groups recognize the importance and value of patient input in the ideation, design, testing and approval of new medical device technologies, but often struggle to elicit and incorporate patient input in a meaningful way. Patients can identify outcomes that are meaningful, risks that they would be willing to tolerate, and practices that can decrease the burden of participation in clinical trials. MDIC is developing a suite of tools to help medical device companies solicit input from patients and patient groups on clinical trial design elements that are aligned with patients’ real-world priorities. Panel attendees will learn about the development of these tools that they can implement in their own clinical trials to develop clinical trials that measure what matters to patients and that patients can complete.

• Intermediate

The Path of Least Resistance – Managing Opposition to Change

One of the biggest challenges to implementing change in an organization is employee resistance to change. This session introduces participants to the challenges and obstacles that resistance poses and presents research-based change management practices to mitigate resistance to change. A real-world case study will be used to demonstrate the principles and will be followed throughout the session. Through structured and guided exercises and small group discussion, participants will have the opportunity to apply the learning to a change they are experiencing in their own organization.

• Intermediate

The Missing Links in CRA Training…How Do We Fix the Chain?

This session will examine the most frequent errors witnessed at a study site due to lack of/poor training on the part of the Clinical Research Associate. Training tips and remediation ideas along with a comprehensive dialogue on how to improve training will be presented. Session participants will be asked to share their viewpoints and experiences as to what they have seen and implemented at their study sites.

• Entry Level

Risk Management, the Crash Course

Are you prepared for the risk management requirements in ICH GCP E6 (R2)? This session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. We will review the key steps of the process: risk identification, assessment, control, review, reporting, management, and communication. Having an effective risk management program not only ensures compliance with the ICH GCP E6 R2 requirements, but also ensures continuous improvement strategies for your clinical trials. Practical take-aways will be shared along with sample tools.

• Intermediate

Regulatory and Legal Changes, the Common Rule, and GDPR: How They Can Impact Study Data Flow Based on Real and Perceived Changes to the Privacy of Information

The session will allow the audience to identify and anticipate compliance issues associated with the privacy concerns around the revised Common Rule. It will help the audience understand the reasons why institutions may require steps to help ensure privacy that will no longer be legally required by the revised Common Rule but may be required by research institutions because of ethical concerns. It will also provide the audience with information on the privacy concerns to anticipate when research involves or could involve data covered by the GDPR.

• Intermediate

Project Review- A Transformational Change in Project Delivery

It is critical to manage the performance on a project through key operational indicator metrics. Those metrics measure the current operational and financial health of the project that allow the project team to ensure the project deliverables based on the contract and statement of work are met. In this session attendees will learn, through this ongoing review process using key operational indicators, how to proactively identify risks and develop specific and actionable plans. The project manager is able to share this data with the Sponsor to ensure clear visibility and accountability on the project. The goal is to achieve flawless execution on a project by managing to the scope of work and providing quality deliverables within the required timeline.

• Entry Level

Practical Aspects of Study Initiation

Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel.
Methods: provides a practical overview of the significant processes in starting research at a site and a clear understanding of the main components of study initiation: document management, logistics, and people management. Guidance, tools, and resources help the primary investigator and coordinator perform efficiently and understand how their responsibilities tie together with the tasks and duties of others.
Conclusions: Organization and adequate time for the initiation process are critical to successful studies. Multiple activities must be orchestrated and performed concurrently, requiring use of study tools and efficient processes. Identification and use of numerous research resources improve efficiency of study initiation and decrease work load and frustration.

• Intermediate

Post-ICH GCP E6 R2: Institution/Investigator Qualification and Oversight of External Parties in Clinical Trials

Since the publication and global implementation of ICH GCP E6 R2, Institutions and Investigators are grappling with the appropriate and adequate approaches for qualifying external parties (e.g., testing facilities [clinical laboratories, radiology centers, medical specialists [ophthalmologist]) and implementing oversight of delegated trial-related duties, functions, activities and tasks. This session reviews the requirements and includes a panel discussion with experts in institutional research administration, operations and compliance, GCP compliance and a clinical investigator on how to implement the requirements, and how the sponsor/CRO Study Managers and Site Monitors are to monitor and manage the investigator/site.

• Intermediate

Pediatric Research: FDA’s 2017 Adopted Version of ICH E11 Resulting in E11(R1)

The ICH E11 guideline changed the environment of drug development for the pediatric population. In this session the speaker will provide a basic overview of pediatric clinical research to include the specifics written in the ICH E11 guideline and the rationale for the revision based on the FDA’s input. The session will be beneficial for all clinical research professionals working in pediatric trials or those with an interest in the topic.

• Entry Level

Leveraging Technology at the Site: Putting the Humanity back in Clinical Trials

We spend too much time in Clinical Research battling the technology that is supposed to be there to help us. That’s time taken away from caring for the patient. By utilizing available solutions that are designed to align current technologies across silos, we can ease the burden on the research staff, so that Investigators and staff can get back to the disciplines that drew them to the healing arts in the first place. This session will address the technology options available to sites, and participants should walk away empowered, knowing that it’s not an “either-or”, but an “and”; that they can support the patient and still not be shackled by the technology involved.

• Intermediate

Leading Clinical Research Workforce Transformation

The clinical research landscape is complicated and increasingly burdensome to clinician scientists. To better handle the evolution of the research, the role of the clinical research professional has become even more important; employing a top-notch clinical research workforce is critical. In this session attendees will learn how an AMC prioritized the role of the workforce by using the competency-based framework developed by the Joint Taskforce for Clinical Trial Competency (JTF), to implement many initiatives. These institution-wide strategic initiatives include 1) overhaul job classifications, 2) create advancement through a tiering process, 3) establish a professionals network, 4) align competencies with on-boarding and training, 5) create pipelines for clinical research positions, and ) centralize a hiring service.

• Intermediate

Integrating Quality into Investigator-Initiated Clinical Trials

There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial. This session will describe how to apply those principles to investigator-initiated clinical trials utilizing tips, tools and templates available to help along the way.

• Intermediate

Inspection Readiness – Beginning with the End in Mind

Sponsors, CROs, and Investigator sites are all too aware of the stress of preparing for a health authority inspection. The challenge is that most organizations begin preparing for an inspection when a drug is filed for approval or they receive notification of an inspection. The key to a successful inspection is preparing at the start of the study. Ensuring that your Investigator Site File (ISF) and Trial Master File (TMF) are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day. The session will also include common GCP violations that are evident in the TMF/ISF and can result in findings.

• Intermediate

Implementing a Competency Based Onboarding Program for Clinical Research Nurses and Coordinators

This presentation will provide an overview of the key concepts a clinical research nurse or coordinator should know prior to independently managing their own clinical research project and how they should be incorporated into a clinical research training program. Identifying the right tactics to engage adult learners is often a trial and error process and this presentation will explore multiple methods to provide learners with the content they need to know and the pros and cons of each. Attendees will receive checklists, competency scales and week by week guides used in the onboarding program being utilized at Nationwide Children’s Hospital.

• Intermediate

Identifying, Documenting, and Implementing Corrective Action Plans to Improve Site Compliance from a CRO Perspective

This session will provide an overview on how to appropriately identify, document, and address compliance issues noted at sites, from monitoring and Sponsor perspectives. There will be an overview of common monitor findings and a discussion about appropriate next steps for developing effective CAPAs. The escalation of issues to the Sponsor will be discussed along with how to adequately document compliance issues in monitoring reports and follow-up letters. Possible ways in which the Sponsor can handle noncompliances will be addressed, as well as the consequences and risks to the Sponsor and study if compliance issues are not addressed. The objective of this session will be to review site compliance from a CRO perspective, while also discussing practical and effective corrective actions from both the monitor’s and Sponsor’s view.

• Entry Level

How to Create a Culture of Quality at a Research Site

Sites are busy and often overlook quality assurance (QA) and only focus on QA when issues arise or when faced with an audit. This presentation will describe our experience creating a culture of quality using an integrative approach in a team environment. Our techniques are easy to implement and include quality assurance checks, office guidelines, checklists and lessons learned. We will discuss the challenges of implementing a quality management system and how to overcome setbacks.

• Intermediate

Getting Multicenter Studies Under Control with Technology

You’ve just been handed a project: An investigator-initiated study with 20 sites on a tight deadline, and here’s the kicker: It’s up to your small team to manage it on top of all your other work. The three panelists before you have all faced this situation… and triumphed. In this session, learn how they did it. Topics explored include: • Strategic approaches to spread work equitably across study teams • Tips for the most critical phases of your study: Startup, monitoring/QC, ongoing communications and closeout In house tools that give you the leverage to “build it once, use it lots” • Purpose-built tools that enable secure collaboration of documents and tasks • What I’d do differently next time: Learn from our mistakes.

• Senior

Expanded Access vs. “Right to Try”; Navigating Disparate Pathways for Desperate Patients

Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA. More recently, two federal actions have widened this access. 1. A federal law allowing for the “right to try” these same unapproved products has been enacted by US Lawmakers. 2. The previous rules governing expanded access have been modified to streamline the process to expedite such access. How do they differ? How should regulatory and research professional advise and/or assist patients faced with these choices? This session will provide a current and complete description of the two pathways, their advantages and challenges.

• Intermediate

Effective Project Management to Streamline your Clinical Trial Workload

In clinical trials, studies are complex, time-intensive and leave little to no room for error. Particularly when conducting concurrent studies with limited resources, it can be difficult to ensure quality and timely data collection and entry on every study. This can lead to stress and unhappiness with staff despite the meaningful work they contribute to improve treatment options. Clear and effective project management can make or break the success of a clinical trial, and project planning and management are a key part of achieving quality clinical data.

• Senior

Compliant Clinical Trial Contracting- Sponsor and Site Perspectives

Emily Pauli, PHRMD, Director of Research at Clearview Cancer Institute (in Huntsville, AL) and Amy Schmidt, DBA, MBA, CCRC, Compliance Manager, AbbVie (Mettawa, IL) will provide the perspective of both the Sponsor and the Site regarding FMV, SOC and Subject/Travel Reimbursement in clinical study budgets. There are two vantage points to contracting and this session will allow the audience to hear from both regarding their processes and how they mirror and possibly conflict….and suggestions how to have a positive outcome for both parties.

• Intermediate

Combating Increasing Complexity of Clinical Trial Data with Expanded Skill Sets and More Teamwork

The number of data sources in clinical trials is increasing and the data coming from those sources are more complex than ever. According to a recent Tufts study, there has been a 20% reduction in EDC as the single source of clinical trials data. What does that mean for the future of data handling and interpretation? It is a broad problem that touches many more areas than just traditional clinical data management. This session will address how skill sets across multiple clinical research disciplines including bioinformatics, statistics, project management and clinical operations will need to broaden, and discuss why greater teamwork, cross-functional collaboration, and minimization of organizational silos are needed.

• Senior

Clinical Research Management Transformation: Infrastructure, Process, and Technology

Clinical research program management is highly complex and requires coordination, communication and cooperation among multiple stakeholders, departments, and teams. Improving research management workflows is a priority for research programs. Reviewing organizational capabilities and streamlining multiple systems and workflows throughout the research program infrastructure expedites performance. Transforming research management infrastructure, processes, and technology enables efficiencies, and is key to improving cycle times and reducing redundancies. Identifying and effectively communicating with key stakeholders fosters champions for change and eliminates roadblocks for implementation success. Participants in this Master Session will learn practical, step-by-step transformational strategies and tools, and have the opportunity for hands-on practice using these tools through case studies.

• Intermediate

Clinical Research Site Culture & the Impact on Adverse Event Reporting

Site culture is a significant, yet under-addressed factor on the impact of timely and complete adverse event (AE) reporting; a large component of patient safety and execution of quality clinical trials. AE collecting, documenting and reporting seems straightforward process that can be covered with a standard operating procedure. In reality, the process itself is impacted by the site culture and effective communication among all of the employees at the site. Quality sites also have a culture that recognizes that clinical trials and their participants are complex, thus requiring checks and balances between the team. This presentation will define the negative impact of strained site cultures on adverse event reporting, identify internal and external pressures, and strategies for improving culture, communication, and adverse event reporting.

• Intermediate

Clinical Project Schedule Management: Successful Start-Up Planning

Successful clinical trial projects don’t happen, they require effective planning and processes at both the site and sponsor/CRO to meet timelines. The use of a project management tool, a Work Breakdown Structure (WBS) to define clinical trial start-up tasks, timelines, and assignments is an effective method to improve project success. Instruction on how to implement a WBS for clinical trial start-up planning will be mapped out along with best practices to ensure successful communication between the investigative site departments responsible for timely deliverables to the sponsor/CRO.

• Senior

Clinical Misconduct: Examples and Implications for your Clinical Staff

The Buck Stops with the PI… or Does It? Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. This session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. Using case studies and actual findings, participants will learn about clinical trials compliance, what kinds of misconduct have occurred in the past and the consequences of a finding of misconduct. Reasons for committing fraud will be explored.

• Entry Level

Careers in Clinical Research: Charting a Path for CRO Professionals

A career in clinical research as a CRO professional has many advantages – plentiful demand, good compensation, and the ability to make a positive impact – but investigating and exploring these career opportunities can be difficult for those unfamiliar with contract research organizations. In this presentation, we’ll look at a number of different career path options available at CROs, identify how to get started on these paths, and discuss the skills and knowledge you’ll need to progress along those paths. The presentation will include real world examples including those who start their professional careers at a CRO, those who transition from other jobs and industries, some common career paths, and some not so common ones.

• Intermediate

Building Relationships & Collaboration: Sponsors and Sites

Currently, there is often confusion or lack of understanding regarding the roles of the CRC and CRA. we need to take the time to understand each other’s backgrounds and expertise, and then align these competencies in effective collaboration. Taking the time to do this by the CRC and CRA would make the best use of our limited time together promoting a quality and timely work product. We have often heard from CRCs that they look to CRAs as their first point of Sponsor contact, a guide and support, not just a someone to verify data against source documents. CRAs look to CRCs for their expertise at implementing a protocol at the site. How can we maximize our roles to effectively reach our individual goals while supporting each other?

• Intermediate

Big Data, RWD & RWE – What’s the Difference and How is it Changing the Research Landscape?

Real world data (RWD) involves data collected outside of clinical trials, and produces real world evidence (RWE), becoming actionable when powered by analytics, machine learning & artificial intelligence (AI). RWE provides insight beyond traditional clinical trial data, adding potential to link data from different sources; improve trial efficiency; identify new indications, and a real-world perspective of risks/benefits to make informed decisions beyond traditional clinical trials. This session reviews RWE regulatory and market impact including the updated FDA guidelines requiring RWE use in regulatory decisions and how AI and information exchange can be securely managed. It will also highlight ethical and privacy concerns, reviewing recent big data consent guidelines and how to clinically integrate RWD. This session shows best practices from a clinical setting that has multiple RWE publications.

• Entry Level

Applying Six-Sigma Tools and Concepts to Your Clinical Research Activities

Six Sigma is a certification that can be achieved but it’s also concepts and practices to apply to everyday activities. The way regulated processes, documents and work practices are handled and executed offer opportunities on a daily basis.

• Entry Level

ALCOA-C Redefined: Writing Effective Site Monitoring Visit Reports

Detailed and accurate documentation, source or otherwise, is crucial in clinical research and yet the site monitoring visit report is often perceived as a “B-list” celebrity when compared with the superstar, source documentation. This session will shine the spotlight on the site monitoring visit report and provide guidance to CRAs on how to not only document observations at the site but also to communicate key information to the trial team in an effective manner.

• Intermediate

7 Breakthrough Behaviors For Clinical Research Project Managers

Clinical Project Managers (CPMs) can spend a considerable amount of time “firefighting”. This talk will present 7 behaviors that CPMs can internalize and demonstrate to prevent firefighting. The discussion will also include real-world examples and tried-and-true techniques that will help avoid some of the pitfalls, along with the hefty benefits garnered when the behaviors are embraced.

• Intermediate

Innovative Solutions. Best Practices. Excellence in Cancer Research

Dr. Skip Burris will present some of the challenges in Oncology research and some of the innovative solutions that he and his team at Sarah Cannon Research Institute have implemented to overcome these challenges. He will share some best practices and resources that can be utilized by other institutions and most of all he will share his key takeaway in clinical research that you won’t want to miss.

• Intermediate

Office of Regulatory Affairs (ORA) Update

This session will focus on an overview of the Office of Regulatory Affairs “Program Alignment” initiative including new divisions, what the initiative will mean for your next (or first) inspection, and who to contact with concerns. This session will also provide a review of current metrics associated with the Bioresearch Monitoring (BIMO) program, including common regulatory violations. Finally, recently released guidance documents and regulations changes related to good clinical practice will be discussed.

• Entry Level

Set Extraordinary Expectations

Kristin Smedley is proof that a change in perception can drive one person to impact an entire field. Eighteen years ago Kristin was on course to achieve her dream: Teacher of the Year. However, fate had an unanticipated outcome for her destiny. Her two sons were diagnosed soon after birth with a rare blindness. Although Kristin was initially paralyzed with fear, she launched an extraordinary mission to change their bleak future. Kristin will demonstrate how the power of perceptions and expectations drives your outcomes and discuss components necessary to ignite your own extraordinary journey through her (often hilarious) real life stories and examples.

• Intermediate

Evolution of the Clinical Research Workforce for the Future

TBD

• Intermediate

Advancing Medical Device Innovation and Safety: An FDA Perspective

CDRH’s vision is that patients in the US have access to high quality, safe and effective medical devices of public health importance first in the world. Ten years ago, the medical device regulatory landscape was perceived to have limited options for bringing new therapies and devices to patients in a timely manner. Today, however, that outlook has changed due in part to the significant efforts that FDA has taken to advance medical device innovation and safety by focusing on our vision. This presentation will provide an overview of multiple CDRH initiatives across the total product lifecycle ranging from streamlined regulatory approaches for clinical studies to new programs for expediting review of devices which address unmet medical needs, and increased opportunity for using real world evidence to support regulatory submissions.

• Intermediate

Thinking Ahead – Enterprise-Wide Implementation of a Clinical Research Management System

Duke invested in a new clinical research management system (CRMS) to improve quality and support reworked business processes that create administrative simplicity and operational excellence. The CRMS is the central tool to track the clinical research operations portfolio. Its integration with the electronic IRB system (a 1:1 match on protocols, including exemptions) is critical to understanding the diverse clinical research activities across the institution. This required Duke to: implement system-wide workflows, create pathways for heavy and infrequent users, and develop tools for monitoring non-compliance and data completeness. The CRMS has been integral in helping study teams use standardize workflows. Nearly a year post-go live, this presentation will review key success factors, decision points, challenges and successes of an enterprise-wide adoption of Forte’s CRMS, OnCore.

• Intermediate

Transformational Technologies in Pharma – What’s Here, What’s Coming – and Why Now?

Technology is changing at light speed and the automobile, retail, airline, finance and many other industries have made a concerted effort to adapt to such. The pharmaceutical industry has been a lager in adapting to newer technologies and clinical trial processes have evolved very little in two decades. However, the regulatory authorities are embracing an effort to transform clinical trials and change is now inevitable for sponsors, CROs, clinical sites and patients. How are/will wearables, digital therapeutics, digital medicine, real world data, machine learning, artificial intelligence and telemedicine impacting the future of clinical trials; are we all ready for it – is the real question. All clinical research professionals will want to attend this session to assess your readiness and how you may want to prepare.

• Entry Level

Cybersecurity: Is Your Clinical Research Data Protected?

Maintaining the confidentiality, integrity and availability of data and systems is critical in healthcare. A cyber-security incident could result in the compromise of critical information or systems, disruption of operations, and even harm to patients. For these reasons, multiple layers of security defenses are needed to protect our people, data, devices, systems, and networks. People in all roles need to understand the critical part they play and how to utilize processes and technology to protect our ecosystem.

• Intermediate

CDER BIMO Compliance and Enforcement: What You Need to Know

Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one. The speaker will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

• Entry Level

ACRP ICH Gap Analysis: Are You Ready for the Certification Exam?

This interactive 4 hour session will navigate you through the main ICH guidelines (E2a, E6 R2, E8, E9, E11) and the Declaration of Helsinki which are noted on the ACRP certification exams. The session will help you create an analysis of where you may need to focus your studies. A discussion of the exam format and valuable strategies for exam preparation will be discussed. This session is not intended for those that are preparing to take the exam in the Spring cycle as this is merely a gap analysis to help prepare you for the format of the exams and where you may want to focus in preparation for any of the ACRP main certification exams (CCRA, CCRC, CPI, ACRP-CP).

• Entry Level

Working Smarter, Not Longer

Looking to find new ways to organize and increase your workload without becoming overwhelmed? This session will break down how you can better understand your strengths and utilize them to improve productivity. We will cover how this can be applied in the patient setting to provide the best care for your patients before, during and after the visit. We will also cover how you can use these skills to improve communication and data deadlines with sponsors. Lastly, this session will cover tips and examples where organization and multitasking can improve the amount of work being completed.

• Intermediate

Why Do Surgical Placebo Controlled Trials?

In this session, the rationale for surgical placebo-controlled trials will be reviewed. One example of such a trial is the world first randomized placebo-controlled trial to evaluate the efficacy and cost-effectiveness of decompressive surgery for lumbar spinal stenosis, which is currently being conducted in Australia. A variety of techniques have been used to address ethical and safety considerations including the unusual step of recruiting a consumer and ethicist to act in advisory roles to provide input on the practicalities of the study design. This session will provide attendees with a high level overview of the trial together with highlighting key learnings about protocol design, consent form drafting and collection of consent, recruitment of surgeons, working with private healthcare providers, and other relevant site level activities.

• Intermediate

Understanding Regulatory Guidance for Gene Therapy Development

It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA. In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Vaughn will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products.

• Entry Level

Top Tips for the New Patient Advocacy and Recruitment

Social Media has been a new highly innovative and disruptive technology to many industries, but most importantly clinical trials. Our latest talk on social media breaks down, step-by-step, the latest techniques for patient recruitment, retention and advocacy across the new and old platforms including: Snapchat, Instagram and Facebook.

• Entry Level

The Evolution of Source Documents

This presentation is for a new coordinator or for coordinators who would like a refresher. The presentation will address the creation of comprehensive source documents and how to incorporate source documents within the electronic medical record system without creating more work. Source documentation is critical for obtaining accurate data. The number one cause of FDA 483s reported is that sites are not following the protocol. Therefore, developing well written source documents will provide detailed instructions on the information that must be collected. The presentation will also discuss utilizing the electronic case report form manual to identify additional data points to include in their documentation. Source documents should be organized in such a way that anyone is able to complete a visit without missing essential data points.

• Intermediate

Scope- What Is It and Why Should I Care

While most of us intuitively understand the concept of scope, many do not firmly understand how project managers use the terms “scope”, “scope creep”, and “scope change”. After defining these terms, we will review parameters that most commonly define the scope of a project from both a sponsor, CRO, and site perspective. The importance of tracking scope changes and monitoring for scope creep will be shown using examples of how these could impact on studies.

• Intermediate

Risky Business: Impact of a Risk-Based, Study-Specific Training Program on Research Coordinator Competency in an Emergency Department Setting

This session will describe three important steps to assure RC competency in study procedures at the beginning of a trial: risk assessment, development of a competency based training program, and implementation of that program. Participants will gain an understanding of how to conduct a risk assessment for a clinical trial. They will also learn how to develop and implement this type of program for their studies in order to help increase study procedure awareness and CRC competence. Take-aways will include a training checklist template that can be applied to clinical trial study start-up and a toolkit describing our program.

• Intermediate

Legal and Regulatory Changes: A Year in Review

A lot has happened this year! Get up to speed with this overview session designed to bring you the highlights and breaking news since last year’s ACRP Conference. How are recent legal and regulatory changes fundamentally affecting research? What should research sites and institutions be ready for in the coming months and years? Get answers to these questions and more through this session’s issue-spotting exploration and analysis of changes in laws, regulations, and standards promulgated by FDA, DHHS, the NIH, and ICH.

• Senior

GPS for Study Startup: The Importance of the Critical Path

Site activation cycle times within the industry are now worse than they were over a decade ago by an average of 4 to 6 weeks. Large, global organizations and small ones alike struggle more than ever to manage the complexities of today’s trials and activities on the critical path to activation are always changing. This session will provide practical information on how technologies, best practices, and KPIs can proactively lead life-science organizations towards an entirely different approach to managing study startup.

• Intermediate

FDA Inspections: Understand the Process and Manage the Consequences

This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Part 2 will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s.

• Intermediate

EFS is the new OUS strategy for early-phased medical device clinical trials

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue fo regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.

• Entry Level

Achieving the Clinical Trial Experience of the Future

During this interactive session, leaders from TransCelerate Member Companies will candidly share their experiences collaborating to create solutions that will bring about innovative change, and address some of our industry’s greatest challenges. They will discuss a suite of initiatives that, using innovative digital efforts, has to potential to transform the end-to-end clinical trial experience. TransCelerate has been developing solutions to allow patients to easily find trials, understand studies and provide consent, participate in trial information exchange, utilize electronic medicine labels, provide feedback on their experiences, and ultimately own their digital medical records. The audience will learn how the use of patient technologies, The Registry of the Future, eConsent, eLabels, and electronic health records can advance clinical research and create the patient experience of the future.

• Senior

A Five Step Approach to Device Risk Management

Companies are faced with challenges to make medical devices safe for human use. Risk management is an integral part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and causes no harm to the patients, operators or the environment. In other words, the main purpose of the risk management cycle is to reduce or mitigate the chances of failure in the product. In this session participants will look at a five step approach to risk management. In this interactive session participants will gain knowledge into the identification, assessment, evaluation, reduction, control and monitoring of risk that are essential to device risk management. Speakers will provide tools, guidance, and some tips on developing a risk management strategy.

• Senior

2019 Regulatory Update

Join us for a stimulating presentation that offers a high level overview of the recent changes to laws, regulations, policies and trends that affect our industry. Many of these are from FRDA and OHRP buy many are intended mostly for healthcare operations that are unintentionally (or intentionally) bleeding over into research operations.

• Entry Level

Business Development Best Practices: How to Make your Site Stand Out in an Increasingly Competitive Landscape

With the clinical trial landscape becoming increasingly complex and competitive, it is essential that clinical research sites position themselves in a way to stand out from the “competition.” Factors such as a downturn in the volume of trials being conducted in sites’ primary indications leads to increased competition for each study and a potential downturn in the number of active trials at a site. We will discuss industry trends that impact R&D, the key factors that drive them, and the implications for research sites. We will discuss insightful strategies for staying ahead of the curve, such as therapeutic expansion and increasing patient access within existing key indications. Finally, we will discuss key tactics for developing and strengthening CRO & sponsor relationships in order to become a “go-to” site.

• Intermediate

Workforce Innovation Award Finalists: Top 5 Share their Ideas

Come see the top 5 Workforce Innovations Finalists share their innovative ideas in workforce development and have the opportunity to ask questions for your own idea creations.

• Intermediate

The Future of the Clinical Research Industry: Where Are We Headed and What It Means to You

Enjoy a paneled discussion on the future of our industry with perspectives from the FDA, CRO, Site and TransCelerate. Gain knowledge on what the future may look like in each of our panelists perspectives and how they are preparing and how you may want to prepare.

• Intermediate

Insights from Industry Technology Competency and Adoption Survey – What This Means for You and Your Organization

ACRP and Forte have recognized that there is a critical need improve tech adoption in clinical trial operations and to define and refine the technology-related skill sets and competencies. Such competencies will more effectively adapt and develop job descriptions, hiring practices, and training programs that enable a more tech-savvy and more sustainable workforce. Therefore, the two organizations collaborated to launch the Technology Competency and Adoption survey in early 2019. We will be sharing highlights from the survey results with a focus on discussing: • Barriers to competency achievement and technology adoption • How individuals can enhance their individual competency • Best practices for how organizations can foster improved adoption of clinical research technologies.

• Intermediate

A Deeper Dive: What Makes a Great CRA

Join the continued discussion from ACRP 2018 session with data from session participants to gain insights regarding skills and competencies of today contrasted to those of tomorrow for a CRA. This session included a 360 perspective and discussion of what makes a great CRA. Through the proposed session discussion and data, it is a conversation to be continued through a deeper dive into a few key areas. These areas include technology skills, regulatory knowledge and RCA competency. During this session, our team will reconvene to discuss and share specific recommendations for how to ensure CRAs, employers of CRAs and research sites engaging with CRAs are best prepared to support and optimize the performance of individuals who are undergoing a shift within a long-established role for our industry.

• Intermediate

Digital Health: A Clinical & Regulatory Update

Software as a Medical Device (SaMD) is performing a larger and more impactful role in patient care than ever before, and new technologies present new regulatory and development challenges. This presentation explores Digital Health technologies and the challenges and opportunities they present to industry, health care providers, and global regulators. After a brief review of the regulatory approaches used for Digital Health technologies across multiple international venues, the US FDA’s Digital Health Precertification Program will be explored. The underlying principles, philosophy and challenges to digital health tech development will be presented, the real and potential “value” of SaMD will be defined, and implications for research and regulatory professionals will be discussed.

• Intermediate

Knock, Knock… FDA Is Here; Be Prepared for a Regulatory Inspection

What do you do when a regulatory Agency knocks on the door? Turn off the lights? Panic? If you’re prepared, it should be an exercise to ensure your systems are working the way you designed them. We will briefly look at FDA Inspections and how to prepare for the inevitable knock, and discuss resources available to you.

ACRP Certification Exam Prep Part 3 of 3

Planning to earn your ACRP Certification?

The newly-revised ACRP Certification Exam Preparation Course provides eligible candidates guidance on how to prepare for the ACRP certification exams — CCRA(R), CCRC(R) and CPI(R). Familiarize yourself with the exam format, gain valuable strategies for preparing for an ACRP exam, tackle sample exam questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP certification.

ACRP Certification Exam Prep Part 2 of 3

Planning to earn your ACRP Certification?

The newly-revised ACRP Certification Exam Preparation Course provides eligible candidates guidance on how to prepare for the ACRP certification exams — CCRA(R), CCRC(R) and CPI(R). Familiarize yourself with the exam format, gain valuable strategies for preparing for an ACRP exam, tackle sample exam questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP certification.

ACRP Certification Exam Prep Part 1 of 3

Planning to earn your ACRP Certification?

The newly-revised ACRP Certification Exam Preparation Course provides eligible candidates guidance on how to prepare for the ACRP certification exams — CCRA(R), CCRC(R) and CPI(R). Familiarize yourself with the exam format, gain valuable strategies for preparing for an ACRP exam, tackle sample exam questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP certification.

Signature Series: Inside NIH: Turning Discovery Into Health

Understand new initiatives underway at the National Institutes of Health (NIH) that could impact your clinical trial operations. NIH officials will highlight initiatives to enhance the accountability and transparency of clinical research and will discuss “All of Us,” an historic effort to gather data from one million or more people living in the U.S. to accelerate research and improve health. Attendees will also gain insider perspectives and practical tips for grant and funding applications, clinical study reporting requirements via ClinicalTrials.gov, and more.

• Senior

A Global Perspective on Regulations Impacting Clinical Research

This session will examine several regulatory issues that impact US and global trial operations from multiple perspectives. Topics include US and Latin American trial issues, OTC drugs and personal care products used in clinical trials, and new Certificate of Confidentiality rules. There will also be time set aside for Q&A with the expert panel of ACRP Regulatory Affairs Committee Members.

• Intermediate

FDA Device Center Reorganization – What You Need to Know

This session will provide an overview of the reorganization of the FDA’s Center for Devices and Radiological Health (CDRH). Scheduled to begin mid-2018, this significant restructuring will combine the CDRH Office of Compliance, Office of Surveillance and Biometrics and the Office of Device Evaluation into a “super-office,” designed to increase efficiency and effectiveness and to focus on the total product life cycle of medical devices. The restructuring will allow CDRH to review, clear or approve pre-market medical devices and assess these products and their legal manufacturers after market in one office. The FDA’s goals for this move are to enhance information sharing throughout the center, address staffing challenges, improve engagement and professional development of employees, and update IT systems. Attendees will learn how this office will impact submissions, the reporting process, and inspections. The session will also examine the CDRH’s three-year plan outlining its priorities, including employee engagement, streamlining of processes, and building collaborative communities.

Signature Series: The State of the Industry

Join Kenneth A. Getz, MBA, Director of Sponsored Research Programs & Research Associate Professor, Tufts Center for the Study of Drug Development, as he examines the forces shaping the current and future state of the clinical research industry. Explore the individual dynamics of technology, process, and workforce on the industry and their effect on each other.

• Intermediate

What Makes a Great CRA – A 360 Degree Perspective

While beauty may be in the eye of the beholder, views of CRA competency and proficiency also rest in the eyes of different stakeholders. A hiring manager will naturally have a different perspective than the site staff being monitored. And while the industry struggles with the age-old myth that to be a “good” CRA (or be hired as a CRA) you need to have at least two years of experience as a CRA, the situation is becoming even more complex as the traditional role of the CRA is ever evolving. In this dynamic panel discussion, four industry experts will share their observations on the critical knowledge, skills and abilities essential for a great CRA, how these can be developed and assessed and why it is important to consider a holistic view of CRA performance from different perspectives.

• Senior

The Site of the Future – Why Business as Usual Isn’t a Sustainable Option

We are all used to hearing that the demand for quality investigative sites is outpacing the growth of sites to support the clinical research needs of the industry. And, we all know the various methods that have been tried and tested over the years with SMO and site network models which, depending on your perspectives have been more or less successful. What’s different now is that we have new technologies that open up a whole new range of possibilities to creating site models that are more sustainable and provide more patients with the opportunity to participate. In this interactive panel discussion, our industry experts will share more about their visions as well as the practical realities and progress reports for what the site of the future looks like and how this is changing the clinical research site landscape.

• Entry Level

Creating Your Own Career Map to Take Charge of Your Career

Long gone are the days where employees worked for the same company for 30 plus years and followed an employer-driven career ladder to grow their career. In today’s competitive and unpredictable climate, employees can’t rely on established career ladders or guaranteed growth opportunities. Thus, it is incumbent on all of us to have our own personal career map or career development plan in order to get the most out of our careers. Providing different perspectives from the sponsor/site and staffing agency perspectives, our speakers will share their insights and experiences on how you can “own your professionalism” and grow your career in meaningful ways.

Signature Series: A Career’s Journey in Clinical Research Comes Full Circle

Imagine dedicating your career to developing breakthrough therapies for others and one day finding yourself as a study subject. This is reality for Peter and Vicky DiBiaso. After two decades of working in clinical research and championing the value and importance of participation in clinical trials, the DiBiaso’s are now engaged as study volunteers and advocates living with Parkinson’s. Come gain a deeper understanding and broader perspective of clinical research as Peter and Vicky share their candid observations and experiences.

• Intermediate

Clinical Research 3.0 – The Impact of Technology on the CR Professional of the Future

New technology is being introduced to clinical research operations so rapidly that it seems like a daily occurrence. At the same time, the roles of clinical researchers are changing as these tools are put into place. Some simplifying the work load, others seemingly making it more complex. This session will look at these trends and use a “crystal ball” to tell us the expectations of clinical researchers in the future.

Signature Series: Advances in Competence and Career Path Standardization Initiatives

Learn about collaborative initiatives to standardize professional competence and career paths in clinical research. Attendees will learn about the Core Competence Framework for Clinical Trial Monitoring and hear a case study on its use in AstraZeneca’s initiative to internalize its monitoring program. Updates on development of the Core Competence Framework for Clinical Research Coordinators will also be shared.

Signature Series: Meet the Changemakers: Driving Clinical Research Quality Through Collaborative Leadership

ACRP Executive Director Jim Kremidas will deliver welcome remarks and provide an overview of the state of the association.

Learn about collaborative initiatives to tackle the most pressing challenges facing clinical development. Executive leadership from the organizations driving clinical research quality improvement through process and technology change initiatives will discuss initiatives ranging from investigator qualification and GCP mutual recognition to quality by design, mobile clinical trials, and more.

• Intermediate

Build a Better Site Budget to Ensure Trial Success

This half-day workshop explores budget preparation in frank terms, using sample clinical trial protocols to demonstrate listed (and omitted) line items that need to be included in your clinical trial budget. Learn how to avoid under budgeting, review generic clinical trial protocols and issues within them that might affect your final budget, and leave with the tools needed to ensure your budget supports successful trial conduct.

• Entry Level

Writing, Monitoring, and Documenting Protocol Deviations: Practical Tips

Master your understanding of protocol deviations, one of the most common problems identified in FDA inspections and the main reason for the rejection of data from a site or study. Speakers will address actions necessary when a deviation is found and the importance of all persons involved in clinical trials understanding deviations. Leave with a solid grasp of the characteristics of an evaluable subject, who can identify a protocol deviation, and methods for writing clear deviation descriptions.

• Senior

What’s Next in Satellite Sites: A Sponsor and Site Perspective

Hear a firsthand account of sponsor and site perspectives on managing and conducting a large, multicenter medical device trial involving a large network of satellite sites. Presenters will discuss the emergence of satellite sites in the current climate of hospital mergers with healthcare networks and/or clinics merging under a single healthcare entity. Leave with a clear understanding of what a satellite site is, the ability to evaluate whether a satellite site is suitable for clinical trial conduct, and the knowledge to apply this information to current practices.

• Entry Level

Virtual Teams: Challenges and Rewards

Virtual teams spread over wide geographic regions and multiple time zones bring unique challenges for those charged with their leadership. Learn about the increased use of virtual teams and the key challenges when working with a virtual team. Hear examples and practical tips used by the speaker in building a virtual team from the ground up, and take away communication strategies to support commitment and engagement from all team members.

• Senior

Using Data Analytics to Optimize Site Performance and Prepare for the Wave of Consolidation Impacting the Site Sector

Powerful forces are impacting the site sector, leading to accelerating consolidation of sites into integrated site operations enterprises, formerly called SMOs (Site Management Organizations). As a research professional and industry leader it is imperative to be proactive in combating these market forces. Learn the steps you can take today to implement processes and use data analytics to tout and display your site’s therapeutic and operational strengths while proactively shoring up weaknesses. As a result, your site will witness enhanced value and long-term stability to enable it to thrive regardless of the powerful forces shaping the entire clinical trials industry and now cascading down to the site level.

• Intermediate

Unleashing the Value: How Integrating Your EMR and CTMS Can Become Reality

Get the tools you need to reap the benefits of an electronic medical records (EMR) / clinical trial management system (CTMS) integration. Speakers representing Cerner PowerTrials, IBM CTMS for Sites, and a research site will break down the value of components of EMR/CTMS integrations and discuss how these interfaces can be implemented. Leave with a strong understanding of the considerations and configurations that need to be made for a successful EMR/CTMS integration.

• Intermediate

Transitioning from CRC to CRA: The Why, When, and How to Make it Happen

Gain the tools and knowledge needed for an efficient transition from study coordinator to monitor. Speakers will share their personal experiences in making the transition, including successes, lessons learned, and effective methods for getting on the monitor career path. Take away a checklist that you can use during your transition, as well as the ability to determine the right time for your career move, to evaluate your competencies and gaps in preparation, and to address your needs during the onboarding process.

• Intermediate

The Seismic Shift in the Monitoring Paradigm: From Quality Control to Quality Assurance

This session takes a practical approach to risk-based monitoring. Clinical monitors, project managers, and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance. Learn about the shift in the monitoring paradigm from the quality-control approach of checking each data point against a source to a quality-assurance (QA) approach that focuses on the systems and processes that generate and report the data. Add the QA methods of interviewing and root-cause assessment to your monitoring toolbox as an effective means of determining the areas in which monitoring resources can have the greatest impact. The speaker will present real findings from a well-established audit program in a risk-based monitoring environment, as well as auditor suggestions, to help you avoid common mistakes.

• Entry Level

The Role of the Lead Monitor and How to Become an Effective One

Learn about the role of the Lead Monitor and take away tools and tricks for meeting the expected responsibilities and deliverables. Speakers will examine the characteristics, background, and experiences required of a Lead Monitor based on survey results from decision makers in the industry. Take away a solid understanding of the importance of building relationships with monitors and the study team, and of the importance of the Lead Monitor as a liaison between various functions.

• Entry Level

The Patient Voice: Improving Patient Experience by Understanding Patient Perspective

Understand the current regulations and guidance related to vulnerable subjects while learning methods for practical application in your daily activities. New threats to the vulnerable arise and corresponding regulation and guidance evolve to address them. The speaker will provide insights on the importance of maintaining a contemporary understanding of vulnerable subjects and adjusting perceptions in order to protect vulnerable subjects in clinical trials.

• Intermediate

The Changing Face of Vulnerable Subjects: Current Regulations and Guidance

Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. But what happens when a coordinator “goes rogue” and is guilty of misconduct? The speaker will explore the definition of misconduct in clinical trials and the possible consequences of intentional misconduct by a coordinator. Hear actual case studies delineating coordinator sanctions and punishments, as well as reasons for committing fraud.

• Intermediate

The Buck Stops with the PI. Or Does It? CRCs Gone Wrong

Regulation states that ultimate responsibility for a clinical trial rests with the principal investigator. But what happens when a coordinator “goes rogue” and is guilty of misconduct? The speaker will explore the definition of misconduct in clinical trials and the possible consequences of intentional misconduct by a coordinator. Hear actual case studies delineating coordinator sanctions and punishments, as well as reasons for committing fraud.

• Intermediate

Technology and Innovation: Collaboration as the Key to Industry Transformation

“Alone we can do so little; together we can do so much.” Harnessing the power of collaboration truly can alter the healthcare landscape as we know it today. This session will explore the how and why behind today’s collaborations, and share perspectives around the next generation of collaborations. How will we need to work together differently? What may be the most surprising collaboration of the future? What new collaborations need to exist to defy the bounds of innovation and accelerate the prevention, diagnosis, treatment, and – ultimately – cures? This thought-provoking session will bring together a diverse panel of leaders representing some of the industry’s most influential organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health.

• Entry Level

Tech-Driven Sites: The Why and How to Get There

Gain a framework for identifying what research tasks to automate and how to prioritize them among different technology modules, and understand the key elements of an implementation plan. The speaker will discuss the wide and growing array of technology available to assist research sites with recruiting, financial administration, regulatory compliance, source data collection, lab routing, patient stipends, communications, business development, and more. Take away implementation tools such as a vendor qualification checklist, an ROI calculator, a compliance checklist, and a sample SOP, among others.

• Intermediate

Strategies for Ensuring Part 11 Compliance at Research Sites

With the proliferation of electronic regulatory document management systems in clinical research, investigative sites are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 regulations. Learn the various aspects and best practice for helping sites build an appropriate risk based approach to Part 11 compliance for their electronic records. Speakers will explore tools to help sites understand their commitments and document their compliance with the appropriate regulation.

• Entry Level

So You Want to be a CRA. Learn How the Role is Changing

Looking to become a clinical research associate (CRA)? Are you a current CRA wondering how the position is rapidly changing and how you can stay current? This session is for you. The speaker will give real-world perspective on how industry is changing, what it means to someone trying to break in, and what it all means for long-time CRAs. Learn about risk based monitoring, eConsent, exciting new apps, developing technology, and how studies are changing in the way they monitor and look at data.

• Intermediate

Smart Monitoring: Is My Monitoring Adequate?

Review the use of a standard system and tools to compliment the risk-based monitoring strategy. Speakers will pay special attention to effective source documentation review to assess if it meets ALCOA and the process for securing compliance. Learn about key verification points of consent, deviations, and safety while participating in practice exercises intended to identify, investigate, and resolve real-world site compliance issues. This session is a two-part “master series” program.

• Senior

Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs

Gain the tools you need to develop a protocol that meets regulatory and marketing needs through inquiries, surveys, and discussions. Developing device protocols that maximize impact while minimizing costs is difficult, and often does not reach the goal of generating data for both. Developing protocols that either meet the needs of both regulatory and marketing, or setting up post market studies that answer these questions, requires both detective and analytic capabilities. Speakers will shed light on the steps required to determine what data needs to be collected to answer these questions, or support the post market surveillance to do so.

• Intermediate

Professional Development for CRCs: A Shared Responsibility

Receive guidance on how to analyze the professional development resources available and how to create an action plan to customize your own path for growth and advancement. Speakers will lead an open dialogue about development, tools, and strategies available, while challenging you to develop your own unique professional development track that is both defined and measurable.

• Senior

Privacy Regulations: Considerations Before, During, and After the Study

Make sure you know HIPAA Privacy and Security Rules, and the implications of federal and state laws on privacy and information security, as they related to clinical research. The speaker will identify key challenges and common areas of non-compliance, and the different approaches Institutional Review Boards take to meeting regulatory obligations in this arena and their implications on the research team. Take away an understanding of why the structure of an organization – and the status of the researcher at it relates to the clinical component of the organization – can have implications for how compliance is achieved. This session is a two-part “master series” program.

• Intermediate

Preparing for Site Qualification Visits: Critical Steps

Showcase your site in the most positive light by learning the critical steps in preparing for site qualification visits. The speaker will highlight methods for best presenting the knowledge and capabilities of your staff and facility, and for communicating effectively with CRO/sponsor personnel. Whether you need ground-up guidance on establishing infrastructure and preparing for a qualification visit, or you are looking to improving your existing processes and presentations, this session will provide the tools you need to ensure a positive site qualification visit.

• Intermediate

Practical Strategies for Building Lasting Relationships Between Sponsors and Sites

“Coming together is a beginning,” said Henry Ford. “Keeping together is progress. Working together is success.” How do you build a solid sponsor-site working relationship from site identification to closeout and beyond? Checking the appropriate boxes for qualification is a great start, but the goal is to build relationships that continue beyond closeout into the next clinical research project. Learn the key communications between sponsors and sites that set the framework for the duration of a clinical research project. Speakers will pull from their collective 30+ years of experience to present case studies from both sponsor and site perspectives. Take away practical tips for preventing sponsor-site relationship challenges and solutions for resolving them when teamwork is compromised.

• Entry Level

Overcoming the Barriers to Recruitment of Underrepresented Minorities

Learn effective strategies for increasing clinical trial participation within underrepresented communities. The speaker will review data showing how racial and ethnic minorities are underrepresented in clinical research while addressing the rationale behind enactment of the National Institutes of Health Revitalization Act and its effect on minority enrollment in clinical trials. Leave with a strong understanding of the known barriers to recruiting underrepresented minorities and innovative approaches for improving recruitment and engagement within these populations.

• Entry Level

Novel Techniques for Improving Clinical Trial Subject Retention

Explore some of the many reasons more than 85% of clinical trials fail to retain enough patients. Speakers will present innovative approaches for improving subject retention and offer metrics demonstrating the impact of on-home and alternate site clinical services on patients, sites, and study sponsors. Take home strategies to immediately improve subject retention numbers.

• Senior

Navigating SMART Central IRB Startup on the Clinical Trials Superhighway

Learn about innovative CIRB workflows developed by working groups of the National Institutes of Health-funded Trial Innovation Center (TIC). Speakers will outline how they have approached local context review and study site activation under the SMART reliance agreement for multi-center trials, among other topics. Hear how these innovative workflows are paving the way for future research and playing an integral role in accelerating the translation of research to the bedside. This session is a two-part “master series” program.

• Intermediate

Investigator Perspectives and Insights on the Use of Mobile Tech in Clinical Trials: Findings from CTTI’s Mobile Clinical Trials Project

New research from the Clinical Trials Transformation Initiative may help investigative sites prepare for the potentially disruptive shift toward greater use of mobile technology to capture objective patient data in clinical research studies. Presenters will summarize key findings from a series of in-depth interviews with investigators who have conducted both traditional clinical trials and studies using mobile technology, providing insights on the advantages and disadvantages to be aware of when running a trial with mobile technology, budgetary and training needs, and other important factors for investigative site personnel to consider. Explore findings from an initial online survey of potential research participants on the use of mobile technology in clinical research, and learn potential implications for clinical research sites.

• Intermediate

Investigator Compensation: Options and Tips for Sites

Learn the different models by which investigators can be compensated, the basics of the Anti-Kickback Statute, the False Claims Act, the Stark Law, and how they govern investigator payment, and the average per-patient investigator compensation by trial type. Speakers will share one hospital’s experience successfully compensating physicians based on the various types of medical groups and hospital physicians they contract with. Take away tips for successful physician payment negotiations.

• Intermediate

Identifying and Documenting Adverse Events: A Decision Making Process

Improve your understanding of adverse events (AEs) by working step-by-step through the definitions of the different types of AEs and reviewing the recording and reporting requirements of each. The speaker will provide a detailed review of AEs and requirements for assessment, documentation, recording, and reporting. Leave confident in your ability to effectively monitor AEs and ensure patient safety and data integrity.

• Intermediate

Financial Management for Research Sites: Maximizing Your Revenue Potential

Financial management for research sites is one of the most time-consuming and complicated aspects of the clinical research process. Learn several effective strategies for negotiating competitive budgets and contracts for a variety of different types of clinical studies. Speakers will delve into several different hurdles that sites of various setups must overcome, including unfair payment terms, coverage analysis, and claims review, among others. Explore different methods of receivable management, including how to know when renegotiating a budget or contract is possible. This session is a two-part “master series” program.

• Intermediate

FDA Inspections: Understanding the Process and Managing the Consequences

This two-part “master series” program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences for group discussion. In the first session, speakers will cover important Good Clinical Practice topics, and preparation for audits and regulatory inspections. The second session will employ hands-on activities to create corrective and preventive action plans utilizing root cause analysis procedures to address FDA citations in warning letters and 483s.

• Senior

Ensuring Patient Safety and Ethics in the Trenches

This session will address the importance of ethics and patient safety with passion, props, and audience participation. Speakers will lead an active discussion of ethical and patient safety considerations related to informed consent, inclusion and exclusion criteria rationale, the difference between clinical care and clinical research, and much more.

• Intermediate

Effects of Recalls and Safety Alerts on Investigational Device Trials

Explore the impacts of device recalls and safety alerts on clinical trials, and how proactive development of a risk management plan can help minimize confusion and negative consequences. Learn about Unexpected Adverse Device Effects reporting requirements to FDA, investigators, and IRBs. Understand the process of determining the need for a device recall and the steps involved in issuing a recall or safety alert. The speaker will discuss personal experiences and examples of device recalls, safety alerts, and the anticipated impact Unique Device Identification. Gain specific guidance on how to develop a plan for responding to implantable device recalls and alerts from a clinical trial management perspective. This session is a two-part “master series” program.

• Intermediate

eConsent: Improving the Consent Process through Innovative Technology

Imagine being able to consent a participant remotely. With today’s new electronic data capture (EDC) systems, this is a reality. Come learn how to ethically and technically complete an electronic consent (eConsent) by using video, audio, and digital media. The speaker will present a live eConsent demonstration and help expand your consenting skills by empowering you to leverage your EDC system to save time and money.

• Intermediate

Diploma Mills and Phony Degrees: The Alarming Impact to Our Industry

According to Wikipedia there are 400+ Diploma Mills in operation selling fake degrees and another 300+ websites offering counterfeit diplomas. The number of individuals “owning” a fake degree or diploma is hard to estimate, however Allen Ezel and John Bear boldly state in “Degree Mills: The Billion-Dollar industry that has Sold Over a Million Fake Diplomas” that more than 50% of the individuals claiming to have earned a PhD actually have a fake degree. There are not only legal ramifications for someone misrepresenting educational credentials, but the repercussions to the hiring company are just as serious. In this session, the speaker will provide resources to help identify Diploma Mills and Falsified Educational Credentials and discuss alternative solutions to the “Degree Requirement” in place at many companies.

• Intermediate

Developing a Clinical Research Education Program and Implementation Issues to Consider

This interactive, two-part “master series” session is for small sites to large institutions wanting to develop or update their clinical research education programs. Speakers will provide tools, guidance, and some insider tips from the viewpoints of dedicated research sites and large, hospital-based research institutions on issues to consider during implementation. Leave with several takeaways to help develop or update your organization’s education program.

• Entry Level

Defining Quality in Clinical Trial Conduct and Preparing Investigators for Success: Findings from CTTI’s Investigator Qualification Project

GCP training has become the industry standard for meeting sponsors’ responsibility to ensure qualified investigators. Despite the widespread use of this training, little evidence has been collected to determine whether it provides the knowledge and skills necessary to support investigators and their delegates in the quality conduct of clinical trials. In addition, the burden of training that is redundant or of little value, often required before each clinical trial, could make it untenable for investigators to participate in future trials. Rather than accepting GCP training as the default solution for qualifying investigators, the Clinical Trials Transformation Initiative’s multi-stakeholder project team has worked to gain a broader, evidence-based perspective to inform the efficient and effective qualification of site investigators for the quality conduct of clinical trials. Come learn about their findings.

• Intermediate

Data-Driven Communications: What it is and How You Can Use it to Engage Research Stakeholders

Learn how to take a strategic approach to digital communications – underpinned by a metrics model – by hearing lessons learned from those managing the website and social media channels for PCORnet, the National Patient-Centered Clinical Research Network. Speakers will explore the cyclical process of data-driven communication from development through analysis, recommendations, and improvements. Explore opportunities to leverage social media channels in clinical research and hear best practices and case studies. Leave with an greater understanding of audience segmentation and engagement, and how a metrics model can be used to measure digital channel performance and inform website and social media strategy.

• Entry Level

Cost-Effectiveness Analysis Alongside Clinical Trials: A Primer

This session will provide a valuable introduction to contemporary healthcare economics and an understanding of its role. The pressure upon drug and device developers to provide more cost-effective therapies is significant and continually increasing. When conducting a clinical trial, the collection of important economic data in conjunction with medical and clinical outcomes is becoming more common. An understanding of the routine conduct of economic evaluations alongside the traditional analyses of safety and efficacy is important for all clinical research professionals. Speakers will review various pharmacoeconomic research designs (cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis, and cost-benefit analysis) using case studies, and explain the concept of quality-adjusted life years which has evolved into one of the leading outcomes in pharmacoeconomic evaluations.

• Senior

Compliance from the Inside: How My Husband’s Untimely Death Taught Me the Real World of Compliance

As a nurse and compliance professional, my recent experience dealing with my husband’s sudden death brought home to me all that I work with every day. The reality of when it is “you” on the receiving end is overwhelming. I want to relate how understanding compliance from both sides helped me to give his organs and tissue for research. Grasping the state of affairs within hours and how compliance came over me was mind boggling. I hope to share my experience to help others who deal with patients every day.

• Intermediate

Cloud-Based Remote Monitoring: Perspectives and Best Practices for Implementation

Come hear case studies of cloud-based monitoring and a conversation about how different stakeholders can cooperate to increase research effectiveness. Speakers will explore remote monitoring from the perspectives of the contract research organization, research site, and technology vendor. Learn about the impact of HIPAA-compliant, cloud-based subject binders, associate regulatory issues such as Certified Copy, and best practices for implementation.

• Intermediate

CDER BIMO Compliance and Enforcement: What You Need to Know

Join FDA personnel from the Center for Drug Evaluation and Research as they discuss key opportunities for the clinical research industry to make their FDA inspection experience a positive one. The speaker will outline recent inspection trends and identify key strategies to build quality into clinical research in order to prevent critical compliance issues. When problems do occur, inspected entities should be able to respond appropriately. Take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence.

• Intermediate

Building Support and Recognition for Clinical Research and Your Role as a Leader

Learn how to effectively gain support for moving clinical research from “just a small department” to part of the broader organizational culture. Hear proven techniques for gaining buy-in for a strategic plan and ongoing engagement, including group leadership, SWOT analysis, mission and vision development, and establishment of a research advisory board. Leave with proven strategies for gaining recognition for the program and establishing yourself as a peer among business leaders within your organization.

• Intermediate

Back from the Brink: Rescuing a Clinical Research Site

Many clinical research sites are operated in organizations that are not otherwise focused on research. At times, such sites might encounter problems that threaten patient safety, study integrity, and the future of their engaging in research. Poorly performing sites can experience poor investigator and participant satisfaction, negative net revenue, and meager quality. A poorly performing site is also at enhanced risk for termination by the parent organization during cost reductions. Drastic actions could be needed to recover the capability of these sites to perform quality research. Come explore how sites might find themselves in such a circumstance, ways to identify what is and is not working, taking corrective actions, and solidifying those actions into a research program focused on quality.

• Intermediate

Applying Implementation Science to Improve the Quality of Clinical Trials in Academia

Unlike clinical studies conducted by industry in which companies provide monitors to help verify data quality, studies conducted in academia often lack such oversight. These investigator-initiated studies would benefit from internal monitoring by, for example, a group of research personnel who might monitor each other’s trials. While all research professionals are frequently training on Good Clinical Practice, the tactical instructions on how to achieve positive outcomes – including approaches to proper monitoring – are lacking. Learn about a novel learning module developed and launched to address this need and an applied framework based on applied science to maximize its effectiveness. The speaker will discuss reasons and methods for developing this initiative, as well as implementation strategies, tools utilized to assess successful implementation, and findings.

• Intermediate

Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective

Learn the ins and outs of adverse event (AE) reporting for medical device trials. Speakers will cover the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on the study protocol, and device AE reporting requirements from a monitoring and auditing mindset. Participate in an active discussion of AE requirements in 21CRF812 and 21CRF312, FDA’s current thinking on AE reporting in device trials and how this might impact which AEs are required to be reported, and how sites might need to delineate AE reporting between the protocol and their Institutional Review Board requirements. Hear several AE reporting case studies from monitoring and auditing perspectives.

• Intermediate

A Framework for Competency-Based Tier Advancement: Lessons Learned

Learn about the Duke University School of Medicine’s experience with a competency-based framework for career advancement. Building on last year’s session outlining the creation of competency-based job descriptions and the process used to match incumbents to these new classifications, speakers this year will address steps taken to provide advancement opportunities using objectively-measured competency assessments. Hear results of the initial tier advancement cycles, lessons learned, and how this tier advancement process is providing clearer career paths for staff while attracting and retaining a valuable workforce.

• Intermediate

A Change (Management) Would Do You Good

Our industry doesn’t have a great reputation for adapting to change. We can point to a variety of reasons why – we’re risk averse, we’re highly regulated, we prioritize conformity over creativity – but no matter how stubbornly we might resist, change is necessary and inevitable. Moreover, the scale and pace of change around us is unprecedented, driven by new technologies and increased pressure to produce better results more quickly. Many organizations are struggling to respond. Explore how change management practices can be incorporated into regular business operations to help clinical research organizations prepare for, adopt, and reinforce change. Speakers will present examples from a few high-impact changes their CRO underwent in the past 3 years and provide tools to take back and apply in your organization.

• Senior

2018 Regulatory Year In Review

Review new laws and regulations passed (or pending passage) within the previous 12 months that are generally not intended to directly govern the clinical research industry but certainly will have direct or indirect impacts and intended or unintended consequences. The speaker will lead an engaging and lively discussion of the regulatory year in review at this always-popular and provocative session.

• Entry Level

“Oops, I Did It Again.” How to Write a Simple (and Effective) CAPA Plan

Learn the basics of what makes a corrective and preventative action (CAPA) plan. Everyone makes mistakes in clinical trial conduct; but it’s how mistakes are addressed that makes the difference between correcting the error or correcting the area and preventing it in the future. The speaker will provide a simple framework to formulate a process for developing a CAPA plan, and offer example plans to further illustrate the process. Leave with an understanding of CAPA implementation, communication, and follow-up considerations.

• Intermediate

“GCP for $500, Alex.” This is Research Jeopardy!

Come play “Research Jeopardy!” Test your knowledge and skills by participating on one of three teams during this interactive session for novices and experts alike. Learn about Good Clinical Practice, research terminology and methodology, human subject protection, and more with fellow attendees in a casual, fun environment. You might surprise yourself by what you know and learn some interesting facts that you don’t.

9th Annual DPharm: Disruptive Innovations

Featuring ACRP Executive Director Jim Kremidas presenting Workforce Innovation: Upskilling Site Staff for 21st Century Clinical Trials

Webinar Replay: We Are Going to Run an Investigator-Initiated Trial!?!? What Do We Do?

This session will communicate effective, simple checklists and best practices for study start up, patient recruitment, tracking of study progress, training and technology resources, and study close out and reconciliation. Webinar Replay expires on June 26, 2020.

Webinar Replay: Designing, Operationalizing and Maintaining a Comprehensive Assessment Driven Clinical Research Orientation

This session will provide tools and define efforts to create and operationalize a comprehensive, competency based, systematic Clinical Research Workforce Development program. Webinar Replay expires on June 12, 2020.

• Entry Level, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, , Trainer

Ethics and Human Subject Protection: A Refresher Course

When in need of a comprehensive refresher, this on-demand eLearning course provides a consolidated overview on the history and importance of ethical conduct in clinical trials involving human subjects.

Webinar Replay: ResearchMatch.org: Empowering the Researcher/Serving the Participant

Join us to learn about ResearchMatch, the national recruitment platform that brings together people who are interested in research, with the research community. Webinar Replay expires May 22, 2020.

Webinar Replay: Single IRB: Getting Ahead of the Curve at a Non-Traditional Academic Medical Institution

In early 2018, Ochsner Health System’s HRPP and the Ochsner Cancer Institute embarked on a journey to discover the best way to use a preferred external IRB. This webinar will discuss their experience. Webinar replay expires May 8, 2020.

Webinar Replay: Who Is the Clinical Scientist and What Do They Do?

Explore the scope of the clinical scientist role, how it differs from traditional study or data management roles, and what skills or experience may be relevant. Webinar Replay expires April 24, 2020.

• Entry Level
• Investigator,

Investigator Responsibilities

Learn the various responsibilities of clinical investigators based on FDA Regulations, ICH Guidance Documents, and international standards.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Save 10% on Training from Barnett International

ACRP and Barnett International’s new strategic partnership provides ACRP Members with expanded access to high-quality education and training, and an exclusive 10% discount on Barnett’s online and in-person programs for clinical research professionals.

• Senior

Improving Recruitment, Accrual, and Retention in Clinical Trials

Explore best practices to improve recruitment and retention with a focus on operational efficiency, cultural competency, and patient centricity. Included tools will help you assess how to better communicate with potential participants and begin a critical reflection of your own skills and organizational practices.

• Senior

Trial Feasibility and Selection: Their Impact on Accrual

Selecting the right trial for your clinical research site is key to the success of your accrual for the trial. This eLearning course will discuss how the menu or portfolio of studies offered at a site has an important impact on accrual and how research professionals can become part of the process.

• Entry Level

Webinar Replay: How to Enter the Clinical Research Field

There are many paths for entering and navigating clinical research careers. This webinar provides guidance that can help jump start your efforts to become a professional in the field.

• Entry Level
• CRC, CRN, Investigator, PR, RM

Implementing a Patient-Centered Informed Consent Process

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.

• Intermediate
• CRC, CRN, Investigator, PR, RM

Using Metrics to Improve Subject Recruitment and Retention

Overcome challenges in subject recruitment and retention by learning how to leverage the metrics critical to success. This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring.

• Entry Level
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Good Clinical Practice (GCP)

Learn the globally recognized standard for conducting ethical and scientifically sound research and to “speak” the universal language of clinical research. This eLearning course is an excellent starting point for anyone wanting to begin work in clinical research and a great refresher for those who have been in the role for some time.

• Entry Level
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Clinical Trials

Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. This free eLearning course details how medical products are developed, how volunteer patients are protected, and key roles in the development, research, review, and approval of medical products.

• Intermediate, Senior

Site Quality Management Tools: SOPs, Metrics and Training

Master quality-related processes and procedures required to ensure trial compliance. This eLearning course is a comprehensive training program that prepares you for the next step of setting up a quality management system– essential information for site personnel involved in quality management and improvement.

• Entry Level, Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Reduce your anxiety by being prepared for clinical trial inspections. This eLearning course takes you through the full cycle of a regulatory authority GCP inspection and answers key questions including: Why, when and where are regulatory inspections performed? Who can be inspected? And more.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety

Efficiently identify and report safety events in your clinical trials. This eLearning course, appropriate for all clinical research professionals, guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.

• Entry Level

ACRP Certification Exam Preparation eLearning Course

Prepare for an ACRP Certification with this comprehensive guide. This eLearning course will help you become familiar with the exam format, tackle example questions, and conduct a personal gap analysis to ensure you are fully primed to earn your ACRP Certification.

• Entry Level, Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, DM, Investigator, MA, MD, MRS, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review

Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Theory to Practice: Operationalize Your Clinical Study Protocol

Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials.

• Entry Level
• BCO, CRC, CRN, DMCTO, Executive, FA, Investigator, MCRA, PMs, RM, RTA, SSSU, Trainer

Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense

Learn the key phases of the budget process and critical components required for consideration, including preparation and study protocol review, study start-up Costs and more. This eLearning course is ideal for both site and sponsor personnel who are tasked with building site budgets and reaching agreeable terms.

• Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Key Skills for Ensuring Quality Control through Risk-Based Decision Making

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more.

• Intermediate, Senior
• CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

ICH Gap Analysis

Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.

• Intermediate, Senior
• CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

GCP Test-Out Challenge: Demonstrate Your Mastery of GCP

A new take on GCP training! This eLearning course, presented in a game format, assesses your GCP knowledge and ability to analyze and apply GCP principles. This course is recommended for individuals with prior training and experience with ICH GCP.

• Entry Level, Intermediate, Senior
• Investigator, MCRA, PMs

Form FDA 1572: Get it Right the First Time

The Statement of Investigator (Form FDA 1572) doesn’t have to be complicated – let us help you get it right the first time. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier.

• Entry Level
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Ethics and Human Subject Protection: A Comprehensive Introduction

Explore the ethical considerations facing clinical research professionals and learn to put the rules into practice to ensure human subject safety and well-being. This eLearning course provides in-depth training on the importance of ethical conduct in clinical trials involving human subjects.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

The Drug Development Process: Improving Trial Feasibility and Exploring Your Growth Potential

Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. This eLearning course puts into practice the ICH E8 guidance document General Considerations for Clinical Trials.

• Entry Level, Intermediate, Senior
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more.

• Entry Level, Intermediate, Senior
• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Trainer

eResearch: Managing Clinical Trials in an Electronic Environment

Learn how to set up and manage electronic clinical research documents in compliance with U.S. and EU regulations, and current trends from both the site and sponsor perspectives. This eLearning course examines the challenges of working with electronic documents and how to overcome them.