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The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

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Focus Area: Clinical Trials & Research

IRR: Returning Routine Lab Results to Participants During a Clinical Trial

Case Study

Released on: March 27, 2023

Description: This case study demonstrates how an industry sponsor operationalized returning routine laboratory results to participants during an ongoing, multi-site clinical trial.

View Resource

Related Resources:
IRR Roadmap by Role.

IRR: Responsibly Returning Secondary Findings

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.

View Resource

Related Resources:
IRR Roadmap by Role.

Post-Trial Responsibilities: Continued Access to an Investigational Medicine

Principles

Released on: December 7, 2017

Developed by: MRCT Center Post-Trial Responsibilities Workgroup

View Principles
Download

Post-Trial Responsibilities to Research Participants

Presentation

Presented on: June 20, 2017

Presented at: DIA 2017 Global Annual Meeting in Chicago, IL

View Presentation
2017-05-11-PTR-DIA

MRCT Center Post-Trial Responsibilities Definitions

Framework

Developed in: March 2015

Developed by: MRCT Center Post-Trial Responsibilities Working Group

View Presentation

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

View Public Comment
MRCT-Center-FDA-Children-comments_FDA-2022Download

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

View Presentation
2019-10-14-Enpr-EMA_Promoting-Global-Clinical-Research-in-Children

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

View Guidance Document
View 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

View Resource
2017-12-07-MRCT-Return-of-Aggregate-Results-Guidance-Document-3.1Download

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.

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The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

75 Francis Street, TH‐14‐1403, Boston, MA 02115, USA
1350 Mass. Ave. (Smith Center #771), Cambridge, MA 02138, USA

mrct@bwh.harvard.edu

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