Case Study
Released on: March 27, 2023
Description: This case details the experience of a research team returning secondary findings to participants in a genetic testing study.
Related Resources:
IRR Roadmap by Role.
Focus Area: Clinical Trials & Research
Post-Trial Responsibilities: Continued Access to an Investigational Medicine
Principles
Released on: December 7, 2017
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Post-Trial Responsibilities to Research Participants
Presentation
Presented on: June 20, 2017
Presented at: DIA 2017 Global Annual Meeting in Chicago, IL
MRCT Center Post-Trial Responsibilities Definitions
Ethical Considerations for Clinical Investigations of Medical Products involving Children: Guidance for Industry, Sponsors, and IRBs
Public Comment
Comments provided on: December 20, 2022
Comments provided to: Food and Drug Administration re: Docket No. FDA-2022-D-0738
Promoting Global Clinical Research in Children
Presentation
Presented on: October 14, 2019
Presented at: 2019 Annual Meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA) in Amsterdam
MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit
Guidance / Tools
Released on: August 2020
Developed by: MRCT Center releases Achieving Diversity, Inclusion and Equity in Clinical Research Guidance Document and Toolkit
Guidance Document
Guidance Toolkit
Return of Aggregate Results to Participants Guidance Document Version 3.1
Guidance
Released on: December 6, 2017
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Dr. Bierer is a guest on the Clinical Research Podcast with ECRG Media
Podcast
Presented on: August 20, 2020
Dr. Bierer discusses “How COVID-19 and A Lack of Diversity has Affected Clinical Trials” on the Clinical Research Podcast with ECRG Media.
Dr. Bierer discusses Diversity in Clinical Research on the Clinical Trials Guru podcast
Podcast
Achieving Diversity, Inclusion, and Equity in Clinical Research A link to the guidance document: https://mrctcenter.org/diversity-in-clinical-research/