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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:

• Harmonized Governance Tools for Data Sharing (Info Sheet)

Sponsor Resources:

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