• Entry Level, Intermediate, Senior

ISO 14155 and FDA Requirements – Trials Conducted at the Research Site

December 5, 2023–Join this live webinar program as we delve into medical devices and investigational medical devices.

• Entry Level, Intermediate, Senior

Building Your Team Through Transformational Leadership in Clinical Research

December 7, 2023–This live webinar will challenge attendees to self-reflect on their own leadership practices and how those may be in need of transformation.

• Entry Level, Intermediate, Senior

Efficiency Unleashed: Optimizing Clinical Research Onboarding and Education

December 13, 2023–Clinical trial professionals with an interest or role in the onboarding and education of new staff are encouraged to attend this live webinar and learn valuable best practices from the steps taken, barriers encountered, and resources available during one clinical trial site’s journey toward realizing its goal for optimal efficiency.

• Entry Level, Intermediate, Senior

Unlearn to Learn: The Evolution of Clinical Research/Trial Training

This session discussed the current way clinical trial training is implemented and ways that it could potentially be done more effectively and efficiently by industry stakeholders.

• Entry Level, Intermediate, Senior

A Review of Medical Record Data Extraction and Adverse Event Reporting

This informative session explores some of the tools of the clinical research trade including data extraction and adverse event reporting.

• Entry Level, Intermediate, Senior

Broadening Your Approach to Trial Diversity on a Global Scale

This live webinar explored diversity through a global lens by tapping into the perspectives of industry leaders who addressed how we can broaden access to a wide range of underrepresented groups, including those who possess attributes linked to troubling and challenging health disparities.

Merck Journeys: Elevating your Career within Clinical Research

This webinar offered a unique opportunity to learn about the rewarding career paths in CSSM. Experienced professionals from Merck shared insights into the innovative clinical research strategies, and discussed how your transferable skills can be leveraged in this field.

ACRP Annual Membership Meeting

ACRP and The Academy leadership joined together to explore highlights of the past year and see what was planned for 2024. Attendees heard how ACRP is working for them and the clinical research profession.

• Entry Level, Intermediate, Senior

Investigator-Initiated Trial Tips and Tricks

This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.

Good Clinical Practice (GCP) Simulation Renewal

The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

Home Study: August 2023

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

• 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

Introduction to Decentralized Clinical Trials (DCTs)

Gain the foundational knowledge clinical research professionals need to implement digital health components in clinical trials.

• Entry Level, Intermediate, Senior

Investigational Drug Services Pharmacists: What They Wish You Knew

How the Investigational Drug Services (IDS) Pharmacy utilized by your clinical trials team works shouldn’t be a mystery, when it can instead be one of your biggest allies in research. This webinar provides “insider insights” from an IDS pharmacist on facts you should have at hand about IDS services when sponsors are considering your site for studies, or are sending monitors to keep track of ongoing projects.

• Entry Level, Intermediate, Senior

How Do IRBs Review Virtual Trial Technology?

How will institutional review boards (IRBs) review study protocols involving the ever-increasing array of mobile health (mHealth) technologies and virtual trial apps on the market? This webinar helps clinical research professionals to understand the regulations and how the oversight of virtual trials might differ from what they have traditionally been used to.

Home Study: June 2023

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

• Entry Level, Intermediate, Senior

ACRP 2023 Full Program – Replay

A replay package of 62 on-demand session recordings and presentation slides from the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. It includes content from the five educational tracks, the Signature Series sessions, Rapid-Fire session, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2026.

• Entry Level, Intermediate, Senior

ACRP 2023 Workforce Development – Replay

This package is a replay of 8 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Understand the workforce landscape and gain strategies to build smarter teams.

• Entry Level, Intermediate, Senior

ACRP 2023 Technology & Future Trends – Replay

This package is a replay of 7 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Gain strategies to optimize technology and move your studies into the future.

• Entry Level, Intermediate, Senior

ACRP 2023 Leadership & Career Growth – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Leadership & Career Growth Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Get the insights you need to advance your career and grow as a leader.

• Entry Level, Intermediate, Senior

ACRP 2023 Regulatory Trends & Compliance – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Regulatory Trends & Compliance Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Hear tips and strategies to mitigate risk and keep your studies in compliance.

• Entry Level, Intermediate, Senior

ACRP 2023 Study Management & Conduct – Replay

This package is a replay of 17 on-demand session recordings and presentation slides from the Study Management & Conduct Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Learn practical, proven ways to maximize study and site performance.

Home Study: April 2023

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

• Entry Level, Intermediate, Senior

2022 Site Perceptions Industry Survey Results: Actionable Insights for Sites, Sponsors, and CROs

Site leaders often feel their voices are not heard during the planning and conduct of sponsored clinical trials, while sponsors and contract research organization representatives feel at odds struggling to enhance relationships with those same sites. This webinar focuses on the results of an industry survey conducted by the Tufts Center for the Study of Drug Development on site perceptions, preparedness, and experiences with new clinical research execution solutions, and offers lessons learned on how you can improve site sustainability and lead more effective collaborations.

• Entry Level, Intermediate, Senior

I Need a Mentor: Where Do I Start?

Career success shouldn’t be measured solely by how far one is able to climb the organizational ladder, especially when reaching career goals depends on so much more than mere effort. In an environment where achievement may rely less on “what you know” than on “who you know,” identifying the right individuals to be part of your knowledge bank and support squad can become crucial.

• Entry Level, Intermediate, Senior

Building a More Equitable Future Together by Driving Inclusion in Clinical Trials

This webinar targets professionals across the clinical trial ecosystem with best practices learned about taking collective action to drive improvements focused on diversity, equity, and inclusion (DEI) issues. You will learn about building trust within historically underrepresented racial and ethnic minority communities, making clinical trials inclusive by design, and fostering partnership to address DEI-related issues in an integrated and sustainable manner.

• Entry Level, Intermediate, Senior

Building Clinical Trial Diversity Action Plans for the Future, Now

Dive into the key elements of a diversity action plan for Phase III clinical trials, as explained in the latest recommendations and requirements from the U.S. Food and Drug Administration (FDA), including considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Learn how these diversity action plans contribute to the study site’s delivery of meaningful data on drug safety and efficacy from to sponsors.

Home Study: February 2023

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

Home Study: December 2022

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

• Entry Level, Intermediate, Senior

A Review of ICH E8 (R1) General Considerations for Clinical Trials

The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.

• Entry Level, Intermediate, Senior

Achieving Global Health Equity Through More Diverse and Inclusive Trials

Ensuring a more equitable and accessible healthcare system starts with the healthcare professionals engaged for pre-drug launch and marketing, with the site investigators recruited by sponsors to run clinical trials, and with the location and availability of the study in terms of diverse and underrepresented populations of potential participants. Here’s a historic overview of what has been lacking in clinical trials when it comes to diversity and inclusion, how federal guidelines are beginning to turn the conversation within big pharma toward health equity, and more.

2022 ACRP/Academy Annual Membership Meeting

Join ACRP/Academy leadership to explore highlights of ACRP’s year and what’s planned for 2023 in the areas of membership, certification, and finances.

Home Study: October 2022

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

• Entry Level, Intermediate, Senior

Ensuring Quality in Fast Enrolling Trials

Are new trials coming at you with break-neck speed? This webinar reviews a case study from a fast-enrolling trial and offers strategies for maintaining high quality standards and recognizing and mitigating the risks of accelerated enrollment.

• Entry Level, Intermediate, Senior

In the DCT Journey, Every Cloud Has a Silver Lining

This webinar focuses on some of the advantages and takeaways learned so far from the introduction, implementation, and adoption of decentralized clinical trials (DCTs). Panelists explore how they operationalized best practices in the areas of budgeting, contract language, remote monitoring practices, virtual visits, and more.

• Entry Level, Intermediate, Senior

ICH E9: A Review and a Look Into the Addendum (R1)

Dive into an overview of both the ICH E9 Guideline on Statistical Principles for Clinical Trials from the International Council for Harmonization and the ICH E9(R1) Addendum, exploring how clinical trials are based on statistical principles and how treatment effects are measured.

• Entry Level, Intermediate, Senior

Understanding the Role of DMCs and EACs in Research Oversight

Take a deep dive into the roles and functions of Data Monitoring Committees/Data Safety Monitoring Boards (DMCs/DSMBs) and Endpoint Adjudication Committees/Clinical Events Committees (EACs/CECs) in the lifecycle of clinical trials. These committees are increasingly tasked with providing independent, expert evaluations of clinical trial events and unbiased adjudications to determine if the definitions of certain clinical trial events have been met.

• Entry Level, Intermediate, Senior

Everything You Need to Know About Holding an IND

This webinar provides a review of the purpose of and expectations set for holding an Investigational New Drug (IND) application through the U.S. Food and Drug Administration, explores common IND-related errors and how to avoid them, and outlines related requirements found in 21 CFR 312 of the Code of Federal Regulations for IND maintenance.

• Entry Level, Intermediate, Senior

Deconstruct Your Clinical Trial to Plan a Positive Outcome: Effective Planning and Communication Strategies

This webinar examines the communication of intent and expectations to stakeholders in clinical trials to minimize risk and gain fluidity in operations, along with key elements behind planning a clinical trial and best practices for budgeting a study.

Streamline Your Clinical Research Organization’s Processes with End-to-End Promotions

Presenting a discussion on how consolidating the processes involved in the phases of drug discovery, pre-clinical research, clinical trials, and post-approval expectations on a single platform drives efficiencies, margin improvements, and real-time collaborations internally and externally. The result is better top- and bottom-line financial performance and consistency in process outcomes during trial execution.

• Entry Level, Intermediate, Senior

Best of ACRP 2022

The “Best of ACRP 2022” package offers recordings from 25 of the most popular sessions from our most recent in-person event, along with seven techXpo sessions, presented by a variety of clinical research service providers.

• Entry Level, Intermediate, Senior

Eliminating Barriers to Careers in Clinical Research

A perfect storm of negative trends is putting immense pressure on entry-level hiring, retention, and overall satisfaction and growth in the clinical research workforce. This webinar focuses on recognizing and overcoming the challenges that are unnecessary barriers to greater participation in the workforce by promising talent from a range of backgrounds and experiences.

• 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 New Work Life Balance in Clinical Research

There’s no denying that “work as usual” has gone out the window in recent years–in the clinical research workforce as well as in most other settings. This webinar explores strategies for juggling a career in clinical research and your personal life in the “new normal,” including in the arenas of excelling at time management in the office and at home, reaching an ideal work/life balance, and acquiring tools to help make your goals a reality.

• Entry Level, Intermediate, Senior

Virtual ACRP 2021 Full Program Replay

ACRP 2021 programming delivers practical strategies, best practices, and creative solutions needed to improve clinical trial quality.

• Entry Level, Intermediate, Senior

Virtual ACRP 2021 Innovation in the Era of COVID Track Replay

Unlock your potential by learning innovative new ways clinical research is being conducted in response to COVID-19. This online, interactive program addresses telemedicine, remote monitoring, team management, study start-up and more in the era of COVID.

• Entry Level, Intermediate, Senior

Virtual ACRP 2021 Regulatory Trends & Compliance Track Replay

Mitigate risk and improve regulatory compliance with insider advice from FDA officials and industry experts. This online, interactive program features FDA officials and industry experts addressing CDER BIMO compliance and enforcement, FDA inspections, ClinicalTrials.gov requirements, and more.

• Entry Level, Intermediate, Senior

Investigative Site Diversity: Tufts CSDD Study on Staff Diversity at Clinical Research Sites

In this webinar, the Tufts Center for the Study of Drug Development team shares survey results on staff diversity at clinical research sites, with an emphasis on the impact diversity has on site performance and its practical implications, the major factors noted for diversity-related success and their associated barriers, and the relationship between site diversity and patient diversity.

The Push for Technology: A Discussion of Implementation Struggles, Strategies, and Lessons Learned

This webinar features a panel discussion on how the pandemic pushed the implementation of new technologies for clinical trials, with a site-centric focus on the struggles overcome and lessons learned, along with the impact on the workforce and how we all may want to prepare for the future.

Best Practices for Communicating Benefit, Risk, and Uncertainty in Medical Device Clinical Trials

This webinar focuses on how research participants cannot make an informed decision to participate in a clinical trial without clear communications from the research professionals supporting the trial. Evidence-based practices are covered to help you conduct patient education and informed consent tied to the benefits, risks, uncertainties, and patient preferences for using new medical technologies.

Using Agile Strategies to Solve Challenges in Research Operations

This webinar looks at how being agile in research settings is becoming a key performance indicator that partners and sponsors are seeking and expecting from sites, with a focus on techniques and strategies you can use to address and solve administrative and operational challenges at a faster rate via pragmatic and thoughtful “big swings of bold.”

• Entry Level, Intermediate, Senior

Virtual ACRP 2021 Operational Efficiencies Track Replay

Boost efficiency in clinical trial management and execution with practical strategies for sites, sponsors, and CROs. This online, interactive program addresses collaboration, protocol feasibility, decentralized trials, remote monitoring, and more.

Clinical Research Staffing Reprioritizations and Resourcing Strategies

This webinar presents lessons learned from a survey on the impacts of the pandemic on staffing at research sites, and discusses implications for the future of clinical research workflows from the current shift to remote operations. When should you look for help or change your staffing approach?

The Future of DCTs: Are You Prepared?

This webinar is tailored for research professionals in sponsor, contract research organization, and study site settings who wonder how to embrace the challenges and benefits of decentralized clinical trials (DCTs), and includes a practical guide for what DCTs really are, how there is no going back, and how it is up to the research professional to adapt to change.

Research Ready: Leveraging Technology in the New Research Landscape

Join Advarra experts in a discussion on how to leverage technology in the new research landscape

Working with Site-Based Paperless Solutions and Ensuring Audit Readiness

Join RealTime experts for an overview of site-based electronic systems that the research industry is rapidly adopting.

Achieving Regulatory Compliance via Collaboration: Technology and Site Perspectives

Join experts from WCG Velos and the University of Kansas Medical Center to learn top practices and processes sites follow to meet compliance standards.

Communication Strategies for Conflict Resolution in Clinical Research Teams

This webinar examines group dynamics, team function, and how conflicts arise within the research team, and considers how specific communication behaviors can foster effective conflict resolution that facilitates team growth.

Career Paths in Clinical Research: Sharing the Journey and Providing Insight

Join a panel of clinical research professionals as they discuss their career paths into and through the clinical research industry, consider the future of their roles, and share advice with those wanting to join the industry. You will gain an understanding of the different research roles, areas that are ripe for career growth and development, and how you can prepare to thrive amidst future trends.

Let’s Talk Patient Recruitment: Strategies, Tools, Communication

This webinar reviews two participant recruitment strategies with guests who have helped increase efficiencies and increase recruitment into clinical trials. Be prepared to walk away with some new tips and tricks that you may be able to implement into your recruitment strategy as well.

Clinical Trial Diversity: Strategies to Support Patients, Sites, and Sponsors

This webinar focuses on ideas for educational outreach to promote the purposes and value of clinical research within organizations and communities, and considers what measures sponsors and sites can take to engage diverse patients in their clinical trials.

Monitoring Investigator-Initiated Trials

This webinar offers organizations valuable knowledge regarding how to create a process for internally monitoring the quality and safety of investigator-initiated trials. Templates, workflows, and other tools are shared so that learners may adapt the proposed program to their own institutional needs.

Improving Technology Proficiency in Clinical Research

This webinar considers how sites are shifting away from sponsor-provided systems into technology that meets their business needs. As the options for technology solutions continue to grow, research sites must develop a true technology strategy and develop proficiencies in selecting, implementing, maintaining, and connecting their technology.

How to Build Advanced Workflows with an Integrated Technology Environment

Join Florence Healthcare to learn how to harness the power of best-in-class software while avoiding digital fatigue, duplication, and wasted time.

Quality Improvements as a Result of Paperless Site-Based Systems

Join RealTime CTMS to examine how paperless sites and site networks are driving quality and improved timelines for the clinical research industry.

Exit the Feature Battle: How to Think Long Term and Prepare Your Site for the Future of Technology in Clinical Research

Join Veeva Systems to explore the key qualities and features sites need to look for in their technology partners to increase their connectivity with sponsors and patients.

Research and Expanded Access in Pandemic Times

This webinar provides an overview of the mechanisms through which, in pandemic conditions, experimental COVID-19 therapies and diagnostics were made available to patients and providers before clinical trials had established whether those products were safe and effective. Also considered are how this state of affairs affected researchers’ ability to generate substantial evidence of product effectiveness through high-quality trials and the U.S. Food and Drug Administration’s deliberations over potential COVID-19 vaccines.

Good Clinical Practice (GCP) Simulation

The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

eSource: Why This is the Platform of the Future

Join experts from Clinical Research IO to explore how several independent trends in research will make eSource a platform technology for sites.

The Impact of Brexit and COVID-19 on Clinical Research Data Processing in the EU/UK

Join The DPO Centre for this exploration of data protection challenges relating to the handling of sensitive personal data of EU and UK trial participants and how COVID-19 has bought data protection to the forefront of people’s minds.

Continuing Organizational SOP Needs to Maintain Compliance (Session I)

This is the first of two webinars offering a deep dive into transforming operational effectiveness by utilizing three key areas in drafting your clinical research standard operating procedures (SOPs) so they are specific, meaningful, and productive for your unique research organization. The stages of the SOP life cycle will be explored beyond merely drafting procedures to include training and enforcement for them as well.

Transforming SOP Infrastructure for COVID Times (Session II)

This second of two webinars on best practices in crafting standard operating procedures (SOPs) for clinical trials applies the concept of emotional quotient-based design thinking to appropriately draft SOPs that include all potential stakeholders. Also considered will be common blind spots within basic compliance mechanisms and the keys for drafting more adaptive SOPs to serve as reference tools and training materials for preparing your organization for new ways of conducting clinical trials.

SARS-Cov-2, the Law, and You

In this webinar, the Association of Clinical Research Professionals and the Society for Clinical Research Sites offer a collaborative discussion on how new laws and regulations arising from the COVID-19 pandemic conditions affect small clinical research sites.

COVID-19 Technology Mad-Dash, What Worked and What Didn’t?

This webinar addresses the challenges of transforming clinical research operations with technology built during the upheavals research sites underwent in the midst of COVID-19 disruptions. You will gain a better understanding of the technology evolution experienced by the clinical research enterprise, how best to future-proof operations to avoid future disruptions such as this, and tips for operating your site with a view of both short- and long-term goals.

Innovative Approach of Using EHR Data to Improve the Speed, Efficiency, Quality and Costs of Conducting Clinical Trials

This webinar describes how a research site’s electronic health record (EHR) data can be used to precisely identify potential subjects from its patient population, thus reducing recruitment and screening efforts and accelerating time to completion of enrollment. Involved are the use of eConsent to enroll patients from their homes, the collection and use of relevant real-world data extracted from the EHR in ways that eliminate certain study visits and manual data entry, and the use of eSource for cutting the need for source data verification.

Practical Tips for Career Development

This webinar describes techniques for developing yourself as a better leader, as well as tools for developing a strong team that fosters open communication and respect of different personality styles. It provides practical tips for developing career ladders for individuals who wish to grow, hints on how to be flexible in terms of your team’s work environments and scheduling, and lessons learned on how to interact with external teams in order to facilitate strong inter-departmental communications and work flows.

Building Relationships With Healthcare Professionals and Community Groups to Increase Enrollment

This webinar focuses on best practices for building and maintaining relationships with healthcare professionals and community groups to increase study enrollment, particularly among diverse patient populations. You will learn how to manage productive physician and community networks that result in highly qualified patient referrals through real-world examples of successful site efforts, and from recommendations on practical adjustments sites can make to their existing strategies to maximize their efforts without overburdening their schedules.

Diversity of Research Personnel: Knowing Who We Are to Know Who We Serve

This webinar highlights how lack of diversity in the recruitment of study subjects impacts the generalizability of research findings, and how evaluating diversity among your research team members will inform study design and recruitment strategies. In turn, this will increase diversity among recruited subjects and make research findings more broadly applicable to wider populations.

Informed Consent Simulation

This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.

ACRP Clinical Research Knowledge Assessment™ (CRKA)

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.

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.

• 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

Clinical Trial Monitoring Basics

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?

• 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.

• Entry Level
• Investigator,

Investigator Responsibilities

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

• 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
• 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 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, 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

Statistical Principles for Clinical Trials: Overview of ICH E9

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

An essential course for all clinical research professionals involved in the clinical trial agreement and/or budget process for industry-initiated trials.

• 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.

• 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: ICH E8(R1) General Considerations for Clinical Trials

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.