Public Comments
Comments provided on: August 5, 2013
Comments provided to: Food and Drug Administration
Focus Area: Quality & Transparency
Submission of comments on ‘Policy 0070 on publication and access to clinical-trial data’
Public Comments
Comments provided on: September 30, 2013
Comments provided to: European Medicines Agency
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Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance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.
Informed Consent Template – No 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 Use Agreement
Presentation
Developed on: March 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.
Data Use Agreement
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