Framework
Developed on: March 23, 2015
Developed by : ICF/Data Sharing Workgroup
This document is available for MRCT Sponsors in Microsoft Word. Click here.
Language: English
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 Contributor Agreement
Framework
Developed in: November 2018
Developed by: MRCT Center/PCORI Open Science Pilot Project
This document is available for MRCT Sponsors in Microsoft Word. Click here.
Data Anonymization – A Key Enabler for Clinical Data Sharing
Proceedings
Report published on: Dec 05, 2018
Co-authored with: European Medicines Agency
Research, Development, and Regulatory Roundtable Info Sheet
Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis, published in Clinical and Translational Report
Publication
Published on: April 8, 2022
Published in: Clinical and Translational Report
Deborah Zarin, MRCT Center Program Director, co-authored “Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis,” published in Clinical and Translational Report. The authors conclude that “clinical trial protocols undercite accessible, relevant trials and do not document systematic searches for relevant clinical trials. Consequently, ethics review committees often receive an incomplete picture of the research landscape if they review protocols similar to those deposited on ClinicalTrials.gov.”
Disclosure and Transparency for Clinical Data Summit
Presentation
Presented on: August 13, 2018
Presented at: Disclosure and Transparency for Clinical Data Summit, Philadelphia, PA
Return of Individual Research Results Resources: Resources for Participants
Tools
Published on: June 2022
Developed by: MRCT Center Return of Individual Results Task Force
Related Resources
Additional Resources, maintained on our project specific
Return of Individual Research Results website:
IRB Approval Checklist for Returning IRR
Healthcare Provider Contact Form Template
Return of Individual Research Results Resources: Informed Consent Sample Language
Tools
Developed on: June 2022
Developed by: MRCT Center Return of Individual Results Task Force
Related Resources
Additional Resources, maintained on our project specific website:
Return of Individual Results
IRB Approval Checklist for Returning IRR
Healthcare Provider Contact Form Template
Return of Individual Research Results Resources: IRR Information Sheet for Participants Template
Tools
Developed on: June 2022
Developed by: MRCT Center Return of Individual Results Task Force
Related Resources
Additional Resources, maintained on our project specific
Return of Individual Research Results website:
IRB Approval Checklist for Returning IRR
Healthcare Provider Contact Form Template