Info Sheet
Developed on: October, 2023
Developed by: The Global Health Network
Focus Area: Clinical Trials & Research
The Evolving Role of PI in the Oversight of Decentralized Clinical Trials
You need to be logged in to view this content. Simple Membership is not configured correctly. The login page or the join us page URL is missing in the settings configuration. Please contact Admin
Joint Task Force for Clinical Trial Competency (JTF) Biannual Global Meeting
November 14, 2023 @ 9:00 am – 11:00 am
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
The public is invited to attend virtual biannual meetings, which happen twice a year.
Details: The meeting included a progress report on the update of the data management and informatics domain, potential amendments to the JTF Framework to accommodate emergency preparedness competencies, utilization of the JTF Framework for workforce development for clinical research, and experience of using the JTF Framework in Canada and Switzerland.
Key Topics:
• Data Management Quick Update: Results from Delphi
• Workforce Development for Clinical Research
• Emergency Preparedness: Proposed Rapid Response Appendix
• Competencies for non-interventional research projects in the Swiss regulatory context
• Update on the use of the JTF framework in Canada under 3CTN
• Update on the Arabic translation
Deliverables
Projects
Amplifying Participant Voices: Crafting Respectful, Inclusive and Understandable Patient Resources
October 23, 2023 @ 12:00 pm – 1:00 pm
As we celebrate Health Literacy Month , we invite you to join us on October 23, 2023, from 12-1 PM ET to explore actionable strategies to incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand — the key tenets of health literacy. This approach enhances engagement, empowers patients, improves communication, and addresses knowledge gaps, paving the way for improved health outcomes and enriched participant experiences.
Click here to register.
Deliverables
Projects
Update on the GDPR & Ensuring Integrity of Clinical Trial Data
December 13, 2023 @ 2:00 pm – 4:30 pm
Topics: 1) Update on the GDPR, including discussion of the EU/US data privacy framework; 2) Considerations for ensuring accurate clinical trials data
OPEN TO THE PUBLIC
GDPR: This session will involve a panel discussion exploring developments occurring in the past year related to the effect of the European Union’s privacy law, the General Data Protection Regulation (“GDPR”), on clinical research. GDPR was the topic of a one-day meeting held in conjunction with the MRCT Center annual meeting in December 2022, and the intent of this panel is to explore what has changed in the intervening 12-month period. Topics to be addressed will include the Trans-Atlantic Data Privacy Framework, the UK-US Data Bridge, ongoing litigation in the EU regarding the definition of anonymization, and the latest relevant European Data Protection Board guidance. The panel will include representatives from leading life sciences companies who advise on data privacy issues as well as a representative of the U.S. Department of Commerce who worked on the Trans-Atlantic Data Privacy Framework.
Ensuring Integrity of Clinical Trial Data: Clinical trials are most often conducted at sites contracted to perform clinical trials. Historically, trials have most often been sited at organized clinics or hospitals, which have reliable systems of ensuring quality of care and creating and maintaining accurate medical records. Yet in recent years, clinical trials have been sited at stand-alone, for-profit research sites that lack the quality assurance infrastructure of clinics or even physician group practices; and in the wake of COVID, clinical trials have often become “remote” or “decentralized.” This session will explore the challenges in this new clinical trial environment to ensuring accurate recording and retention of data, and whether and how monitoring processes should be revised and enhanced.
This meeting is part of the MRCT Center’s 2023 Annual Meeting in Boston on December 13-14 and is open to all registrants at no cost. Guests are welcome to attend the entire program or individual sessions. While in-person attendance is encouraged, virtual participation is welcome.
Click here to register.
Click here for the full schedule and FAQs.
Deliverables
Projects
Returning Individual Research Results and Data: Digging Deeper into Genetic Results and Secondary Findings
Webinar
Presented on: September 21, 2023
Presented at: Virtual
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar in May. Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.
This webinar was the third of the three webinars in the Digging Deeper series. Megan Frone of the National Cancer Institute discussed a case about returning genetic/genomic results and secondary findings.
Related Resources
ACMG/AMP Recommendations for Return of Secondary Findings
NASEM Returning Individual Research Results to Participants
Case Study: Responsibly Returning Secondary Findings
May 2, 2023 webinar: Returning Individual Research Results and Data to Participants
July 27, 2023 webinar: Digging Deeper into Pfizer’s Patient Data Return Solution
August 17, 2023: Digging Deeper into IRB/HRPP Responsibilities
Return of Individual Results website
Defining “recklessness” in research misconduct proceedings
Publication
Published on: September 5, 2023
Published in: Accountability in Research
Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application, and proposing a framework and factors to consider in recklessness determinations.
Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection–Inclusion Dilemma
JTF Framework: Available in Nine Languages
The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators, and clinical research professionals that has developed a framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research.
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Chinese.
Other available translations: English, Spanish, French, Japanese, Thai, Bahasa Indonesia, Italian and Vietnamese.
MORE ABOUT THE JTF FRAMEWORK: DOMAINS AND LEVELED CORE COMPETENCIES
The JTF Core Competency Framework is made up of 8 Competency Domains, which are broad categories of knowledge, skills, and attitudes necessary for conducting clinical research.
Each Domain contains specific competency statements expressed at a Fundamental, Skilled, and Advanced level.
- Fundamental: Can perform the task and/or exhibit the knowledge at an essential or fundamental level; may require some coaching or supervision.
- Skilled: Can perform tasks or skills independently, consistently, and accurately and has a moderate level of expertise. Efficient and high-quality work; able to independently navigate resources and use tools well.
- Advanced: Demonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Consistently applies critical thinking and problem-solving.
The JTF Core Competency Framework (JTF) has been utilized widely and internationally by academic institutions, corporate entities, and professional societies to improve the quality, accuracy, and safety of clinical research. The JTF has compiled a listing of representative publications, presentations, and weblinks to provide examples and references for those entities wishing to utilize the framework to meet their own needs.
Click here to learn more about how to use the JTF Framework.
Returning Individual Research Results and Data: Digging Deeper Webinar Series
Webinar Series
Presented on: July 27, August 17 and September 21, 2023
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar. Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.