See All Resources by Project
Proceedings, Publications, & Public Comments...
Presentations...
Return of Aggregate Results
Focus Area: Transparency
Items listed by newest to oldest in each category.
Frameworks:
- Return of Aggregate Results to Participants (Principles)
- Return of Aggregate Results to Participants Toolkit Version 3.1 (Toolkit)
- Return of Aggregate Results to Participants Guidance Document Version 3.1 (Guidance)
- Draft FDA Guidance on Provision of Plain Language Summaries (Guidance)
Proceedings, Publications, & Public Comments:
- Returning Aggregate Results of Clinical Trials (Publication)
- Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance (Public Comments)
- Summary of Clinical Trial Results for Laypersons – Comments to European Medicines Agency (Public Comments)
- Health Research Authority – Guidance on participant information at the end of a study (Public Comments)
- Harvard MRCT Annual Meeting (Proceedings)
- “Proposed Rule – Clinical Trial Registration and Results Submission” Comments to NIH (Public Comments)
- Compliance with Results Reporting at Clinical Trials.gov (Publication)
- Submission of comments on Draft proposal for an addendum, on transparency, to the ‘Functional specifications for the EU portal and EU database to be audited’ (Public Comments)
- Current and Ongoing Data Transparency Activities in the Pharmaceutical Industry (Public Comments)
- Preparing For Responsible Sharing of Clinical Trial Data (Publication)
Presentations:
- Expectations of ‘Good Lay Summary Practices’ (Presentation)
- Dissemination strategies and options for plain language summaries (Presentation)
- The Voice of the Patient – Returning Aggregate Results through Plain Language Summaries (Presentation)
- Disclosure and Transparency for Clinical Data Summit (Presentation)
- Fourth Clinical Regulatory Medical Writing Forum (Presentation)
- Using Data for the Public Good: Sharing Aggregate and Individual Results (Presentation)
- CBI Clinical Data Disclosure and Transparency Conference (Presentation)
- Ensure Efficient Return of Aggregate Trial Results with the MRCT Toolkit (Presentation)
- Third Clinical Regulatory Medical Writing Forum (Presentation)
- The New World of Transparency for Clinical Trial Results (Presentation)
- Responsible Clinical Trial Data Sharing (Presentation)
- Patient Participation in Clinical Trials (Presentation)
- Harvard MRCT Annual Meeting Return of Results Slides (Presentation)
- Return of Results Initiative (Presentation)
- Operational Planning for Plain Language Summaries and Return of Results (Presentation)
- Practical Implementation of Return of Results to Patients (Presentation)
- Sharing Clinical Trial Data with Research Participants: Regulatory, Operational and Ethical Considerations (Presentation)
- Toolkit and Guidance for Implementation of Returning Results to Research Participants (Presentation)
- Principles of Health Literacy and Numeracy in Returning Trial Results to Participants (Presentation)
- DIA Clinical Trial Data Sharing (Presentation)
- Health Literacy: Fostering Comprehension in Research and Clinical Care (Presentation)
- International Clinical Trials Data Sharing: Principles and Mandates (Presentation)
- Guiding Principles for Clinical Trial Data Sharing (Presentation)
Sponsor Resources:
Please log in to view Sponsor-only resources.