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Tools for Data Sharing
Focus Area: Current Project
Focus Area: Transparency
Frameworks:
- Informed Consent Template – No external Sponsor (Template)
- Informed Consent Template – External Sponsor (Template)
- Data Use Agreement (Template)
- Data Use Agreement (Template)
- Data Sharing Plain Language Informed Consent Form Section (Template)
Proceedings, Publications, & Public Comments:
- Submission of comments on ‘Policy 0070 on publication and access to clinical-trial data’ (Public Comments)
- HHS Finalizes Comprehensive Revisions to the Common Rule (Publication)
- Comments to Docket No. FDA-2013-N-0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data (Public Comments)
- Comments to Docket 2006-D-0031, Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Public Comments)
- Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study (Publication)
Presentations:
- Towards Streamlined Consent Processes and Participant Understanding (Presentation)
- Data Sharing and Informed Consent (Presentation)
Other Resources:
Sponsor Resources:
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