Publication
Published on: May 18, 2018
Published in: Pediatric Research
Language: English
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Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance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.
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.”
