• Entry Level, Intermediate, Senior

Clinical Trial Agreement Negotiation – Everything Your Lawyers Want You to Know – Part I

January 15, 2025—In this three-part series of live webinars attendees will have the opportunity to hear from clinical trial attorneys as they share the critical pieces of a clinical trial agreement and how to mitigate risk. Attendees will gain a better understanding of the requirements of both sponsors and sites and participate in a discussion about how to meet the needs of all parties in the contract.

• Entry Level, Intermediate, Senior

Clinical Trial Agreement Negotiation – Everything Your Lawyers Want You to Know – Part II

January 22, 2025—In this three-part series of live webinars attendees will have the opportunity to hear from clinical trial attorneys as they share the critical pieces of a clinical trial agreement and how to mitigate risk. Attendees will gain a better understanding of the requirements of both sponsors and sites and participate in a discussion about how to meet the needs of all parties in the contract.

• Entry Level, Intermediate, Senior

Clinical Trial Agreement Negotiation – Everything Your Lawyers Want You to Know – Part III

January 29, 2025—In this three-part series of live webinars attendees will have the opportunity to hear from clinical trial attorneys as they share the critical pieces of a clinical trial agreement and how to mitigate risk. Attendees will gain a better understanding of the requirements of both sponsors and sites and participate in a discussion about how to meet the needs of all parties in the contract.

• Entry Level, Intermediate, Senior

Patient Centricity: The Key to Recruitment and Engagement

February 5, 2025—Please join us for this exciting webinar by an inspiring patient advocate and voice for the community as she discusses how to build awareness, strategies, and the idea of technical empathy and how we all can benefit. This webinar will provide the insightful information that you won’t want to miss.

ACRP Budget Virtual Workshop Series: Real-World Budgeting Tactics for Keeping Your Clinical Studies on Track (Three Parts)

February 12, 19, & 26, 2025—The three-part workshop will explore the pre-award activities associated with clinical research site expense management and their impact on the budget development process for sponsored clinical studies. For ACRP Chapter Members ONLY.

• Entry Level, Intermediate, Senior

Enhancing Clinical Trial Diversity: Strategies for Inclusive Patient Engagement

This webinar focused on improving diversity in clinical trials through practical strategies for engaging underrepresented populations.

• Entry Level, Intermediate, Senior

Employers Beware: Fraudulent Study Team Candidates are Fooling Background Checks

This webinar showed attendees that simply conducting background checks and employment verifications won’t always protect from candidates who represent a fake job history.

ACRP and the Academy Annual Membership Meeting

ACRP and the Academy leadership explored highlights of ACRP’s year and plans planned for 2025.

• Entry Level, Intermediate, Senior

Facilitating Understanding in Informed Consent

Did you read the new draft Guidance from the FDA for Sponsors, Investigators, and IRBs on Key Information and Facilitating Informed Consent? Watch this webinar as our speaker discusses this guidance.

Action Steps for FDA Diversity Action Plans

In this webinar, industry experts offered examples of how diversity action plans vary among therapeutic areas — and why one size does not fit all. They also explained why it’s important to incorporate action plans earlier in the clinical trial process, as well as consequences for failing to follow a submitted plan.

• Entry Level, Intermediate, Senior

Who’s in Charge When AI is Let Loose on Clinical Research?

Artificial intelligence (AI) has been touted as holding the solutions to a variety of vexing challenges in healthcare, but is it possible that there’s a downside to integrating what some might call an ungovernable technology into the clinical research arena? This webinar pondered the issue of who’s making sure this power is being used to benefit everyone fairly.

• Entry Level, Intermediate, Senior

How to Make Soft Skills Your Superpower

With such an emphasis on the importance of soft skills, this webinar provided attendees with tools to assess the maturity of their soft skills. The speaker discussed developmental tasks attendees can employ to strengthen or enhance those that may be weak.

• Entry Level, Intermediate, Senior

NIH Partnering with ACRP to Address Challenges Related to Implementing Trials (ACRP 2024 Recording)

Leaders at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognized that in recent years, a large proportion of National Institutes of Health (NIH) funded clinical trials have not achieved target enrollment within the allotted time or budget, and some have been terminated early for futility.¹ Based on a retrospective review of National Heart, Lung, and Blood Institute (NHLBI) funded trials, only 26% were successfully defined as achieving 100 percent enrollment in the target time allowed.

• Entry Level, Intermediate, Senior

From Conflict to Collaboration: Enhancing Site and Sponsor/CRO Relationships

This webinar explored the perspectives and occasional conflicting interests of both parties, fostering mutual understanding. Representatives from each organization shared insights, real-life examples, and practical tools to overcome challenges, promoted productive collaboration, and contributed to clinical trial success

• Entry Level, Intermediate, Senior

Deepening Diversity: LGBTQIA+ Diversity in Clinical Research

In this webinar, expert panelists discussed how sponsors can smooth the LGBTQIA+ patient journey for clinical trials, starting with gender-neutral protocols, making trial communication more inclusive, the FDA’s draft guidance on diversity plans and data collection, and the roles that sites/investigators can play.

• Entry Level, Intermediate, Senior

Merck Journeys: Career Conversations within Clinical Research

Discover the exciting world of clinical research at Merck during this informative event. Hear from professionals from Clinical Data Management, Clinical Science and Study Management, and Clinical Research Associate roles as they discuss their careers, the industry, and their experiences at Merck.

• Entry Level, Intermediate, Senior

The Future of Home Health Care in Clinical Trials

This session provided insights into the presenters experience with home health visits to-date and prompted site and investigator attendees to understand what works and doesn’t work for sites when offered home health options in trial protocols.

• Entry Level, Intermediate, Senior

ACRP 2024 Full Program – Replay

A replay package of 86 on-demand session recordings and presentation slides from the ACRP 2024 Conference, May 3 – 6, Anaheim, California. It includes content from the six educational tracks, the Signature Series sessions, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2027.

• Entry Level, Intermediate, Senior

ACRP 2024 Study & Site Management – Replay

This package is a replay of 26 on-demand session recordings and presentation slides from the Study & Site Management Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Learn practical, proven ways to maximize study and site performance.

• Entry Level, Intermediate, Senior

ACRP 2024 Regulatory & Compliance – Replay

This package is a replay of 13 on-demand session recordings and presentation slides from the Regulatory & Compliance Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Hear tips and strategies to mitigate risk and keep your studies in compliance.

• Entry Level, Intermediate, Senior

ACRP 2024 Clinical Trial Design – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Clinical Trial Design Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Explore the fundamental considerations for effective clinical trial design.

• Entry Level, Intermediate, Senior

ACRP 2024 Leadership & Professionalism – Replay

This package is a replay of 11 on-demand session recordings and presentation slides from the Leadership & Professionalism Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Get the insights you need to advance your career and grow as a leader.

• Entry Level, Intermediate, Senior

ACRP 2024 Workforce Development – Replay

This package is a replay of 11 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Understand the workforce landscape and gain strategies to build smarter teams.

• Entry Level, Intermediate, Senior

ACRP 2024 Technology & Future Trends – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Gain strategies to optimize technology and move your studies into the future.

• Entry Level, Intermediate, Senior

Improving the Understanding of Informed Consent Among Vulnerable Populations

This webinar addressed practical ways stakeholders in research can help improve the creation of ICFs and better the overall process to ensure patients have a fuller understanding of the risks, commitment, and cost of agreeing to participate in a clinical trial.

• Entry Level, Intermediate, Senior

Employee Development and Succession Planning

This webinar targets site and organizational leaders with the kinds of details they need to pay attention to in order to develop the framework for an employee development program which will support succession planning.

• Entry Level, Intermediate, Senior

Intro to In Vitro Diagnostics (IVDs): The Path to Working Together Globally and More Efficiently

This webinar addressed the pressing need for standardized regulatory practices in the field. With advancements in in-vitro diagnostics (IVD), an increasingly interconnected global healthcare landscape, and the growing demand for precise diagnostics, the need for harmonized regulations is paramount.

• Entry Level, Intermediate, Senior

Clinical Trial Process History and Overview

This webinar covered phases of drug development, the history of regulatory development of human research protection, various types of research study designs, conducting a clinical trial, and generic name and trade name of the medicine.

• Entry Level, Intermediate, Senior

Efficiency Unleashed: Optimizing Clinical Research Onboarding and Education

Clinical trial professionals with an interest or role in the onboarding and education of new staff can 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

Building Your Team Through Transformational Leadership in Clinical Research

This webinar challenged attendees to self-reflect on their own leadership practices and how those might have been in need of transformation

• Entry Level, Intermediate, Senior

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

This program explored medical devices and investigational medical devices.

• 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).

• 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.

• 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.

• 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.

• 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.

• 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

Self-Leadership: Winning Strategies for Fulfilling Work and Life (Part 1): Theoretical Foundations and Core Competencies of Self-Leadership

Learn how to use self-leadership strategies to survive and thrive in today’s volatile, uncertain, complex, and ambiguous world.

• 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

Webinar—Self-Leadership: Winning Strategies for Fulfilling Work and Life (Part 2)

Learn even more about using self-leadership strategies to survive and thrive in today’s volatile, uncertain, complex, and ambiguous world, in part two of this webinar. 

• 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

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.

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.

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).

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: Writing Effective SOPs

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 Adverse Events (AEs)

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

Risk-Based Decisions: Key Skills for Ensuring Quality Control

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.