Info Sheet
Presented on: December 5, 2018
Presented at: MRCT Center
Focus Area: Quality & Transparency
Data Sharing and Informed Consent
Presentation
Presented on: November 5, 2014
Presented at: Harvard Catalyst
Towards Streamlined Consent Processes and Participant Understanding
Presentation
Presented on: January 28, 2016
Presented at: CBI Conference: Clinical Trial Data Disclosure and Transparency, Philadelphia, PA
HHS Finalizes Comprehensive Revisions to the Common Rule
Publication
Published on: January 26, 2017
Published in: Bloomberg BNA Life Sciences Law & Industry Report
Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study
Publication
Published on: May 18, 2018
Published in: Pediatric Research
Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov
Publication
Published on: February 18, 2020
Published in: PLOS l ONE
Comments to Docket No. FDA-2013-N-0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data
Public Comments
Comments provided on: August 5, 2013
Comments provided to: Food and Drug Administration
Submission of comments on ‘Policy 0070 on publication and access to clinical-trial data’
Public Comments
Comments provided on: September 30, 2013
Comments provided to: European Medicines Agency
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Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance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