Presentation
Presented on: November 22, 2014
Presented at: Causality Assessment Workshop, Gurgeon, India
Language: English
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Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance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
Informed Consent Template – External Sponsor
Framework
Developed on: March 23, 2015
Developed by : ICF/Data Sharing Workgroup
This document is available for MRCT Sponsors in Microsoft Word. Click here.
Data Sharing Plain Language Informed Consent Form Section
Framework
Developed on: November 2018
Developed by: MRCT Center/PCORI Open Science Pilot Project
This document is available for MRCT Sponsors in Microsoft Word. Click here.