Training Material
Released on: February 2020
Developed by: MRCT Center Task Force
Interpretation and Application of ICH E6(R2) E-Learning
Language: English
Responsibilities of Data Monitoring Committees: Consensus Recommendations
Publication
Published on: May 13, 2016
Published in: Therapeutic Innovation & Regulatory Science
Accepted manuscript is available here.
Causality Assessment Workshop for Clinical Trial Investigators
Presentation
Presented on: November 22, 2014
Presented at: Causality Assessment Workshop, Gurgeon, India
Harvard MRCT India Regulatory Update, Causality and Compensation
Presentation
Presented on: December 3, 2014
Presented at: MRCT Center at Harvard Annual Meeting, Harvard University
Harmonized Governance Tools for Data Sharing Info Sheet
Towards Streamlined Consent Processes and Participant Understanding
Presentation
Presented on: January 28, 2016
Presented at: CBI Conference: Clinical Trial Data Disclosure and Transparency, Philadelphia, PA
Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study
Publication
Published on: May 18, 2018
Published in: Pediatric Research
Comments to Docket 2006-D-0031, Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
Public Comments
Comments provided on: September 11, 2014
Presented at: Food and Drug Administration
Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance
Public Comments
Comments provided on: January 7, 2020
Comments provided to: National Institutes of Health, Bethesda, Maryland
MRCT Center submits comments to National Institutes of Health (NIH) on Developing Consent Language for Future Use of Data and Biospecimens
Public Comments
Comments provided on: September 28, 2021
Comments provided to: National Institutes of Health, Bethesda, Maryland