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Resource
Project
  • Publication
May 1, 2023
Data sharing in the context of community-engaged research partnerships
Data Sharing
  • Annual Report
December 15, 2022
2022 MRCT Center Annual Report
Advancing the Quality of Clinical Trial Enterprise , Data Sharing , Diversity, Inclusion, and Equity in Clinical Research , Health Literacy in Clinical Research , Post-Trial Responsibilities , Promoting Global Clinical Research in Children , Oversight and Implementation of Decentralized Clinical Trials , Bioethics Collaborative , Research, Development, & Regulatory Roundtable (R3) , Return of Aggregate Results , Return of Individual Results
  • Proceedings
December 14, 2022
MRCT Center 2022 Annual Meeting Proceedings
Data Sharing , Diversity, Inclusion, and Equity in Clinical Research , Research, Development, & Regulatory Roundtable (R3) , Training & Education
  • Presentation
March 21, 2022
Future of Clinical Trial Data Sharing Slides Day 1
Data Sharing
  • Public Comments
February 24, 2022
The MRCT Center Submitted Public Comments to the National Institutes of Health (NIH)
Data Sharing
  • Annual Report
December 7, 2021
2021 MRCT Center Impact Report
Advancing the Quality of Clinical Trial Enterprise , Data Sharing , Diversity, Inclusion, and Equity in Clinical Research , Return of Individual Results , Promoting Global Clinical Research in Children , Research, Development, & Regulatory Roundtable (R3) , Bioethics Collaborative
  • Public Comments
September 28, 2021
MRCT Center submits comments to National Institutes of Health (NIH) on Developing Consent Language for Future Use of Data and Biospecimens
Data Sharing
  • Publication
February 18, 2020
Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov
Data Sharing
  • Public Comments
January 7, 2020
Comments to NIH on Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance
Return of Aggregate Results , Data Sharing
  • Annual Report
December 4, 2019
2019 MRCT Center Impact Report
Global Regulatory Engagement , Real World Evidence , Impact of Privacy Laws on Clinical Research , Promoting Global Clinical Research in Children , Health Literacy in Clinical Research , Diversity, Inclusion, and Equity in Clinical Research , Bioethics Collaborative , Research, Development, & Regulatory Roundtable (R3) , Proactive Safety Surveillance: A Global Approach , Data Sharing , Advancing the Quality of Clinical Trial Enterprise , Training & Education , Joint Task Force for Clinical Trial Competency
  • Publication
June 4, 2019
Credit Data Generators For Data Reuse
Data Sharing
  • Proceedings
December 5, 2018
Data Anonymization – A Key Enabler for Clinical Data Sharing
Data Sharing
  • Annual Report
December 5, 2018
2018 MRCT Center Impact Report
Training & Education , Joint Task Force for Clinical Trial Competency , Diversity, Inclusion, and Equity in Clinical Research , Health Literacy in Clinical Research , Bioethics Collaborative , Research, Development, & Regulatory Roundtable (R3) , Data Sharing , Global Regulatory Engagement
  • Other
December 5, 2018
Harmonized Governance Tools for Data Sharing
Data Sharing
  • MRCT Sponsor Resource
  • Tools
November 1, 2018
Data Use Agreement Word Document
Data Sharing
  • MRCT Sponsor Resource
  • Tools
November 1, 2018
Data Sharing Plain Language Informed Consent Form Section Word Document
Data Sharing
  • MRCT Sponsor Resource
  • Tools
November 1, 2018
Data Contributor Agreement Word Document
Data Sharing
  • Framework
November 1, 2018
Data Contributor Agreement
Data Sharing
  • Framework
  • MRCT Sponsor Resource
November 1, 2018
Data Use Agreement
Data Sharing
  • Framework
November 1, 2018
Data Sharing Plain Language Informed Consent Form Section
Data Sharing
  • Publication
May 18, 2018
Assessment of a Shortened Informed Consent Form for Pediatric Research: A Pilot Study
Data Sharing
  • Proceedings
April 9, 2018
Implementing A System to Enable Credit for Data Sharing
Data Sharing
  • Presentation
August 21, 2017
Advancing Data Sharing: Data Collection As a Key Component
Data Sharing
  • Publication
August 8, 2017
What Do Revised U.S. Rules Mean for Human Research
Data Sharing
  • MRCT Sponsor Resource
  • Presentation
July 25, 2017
Guiding Principles for Clinical Trials 2017
Return of Individual Results , Data Sharing
  • Other
June 28, 2017
About Vivli
Data Sharing
  • Publication
March 29, 2017
Data Authorship as an Incentive to Data Sharing
Data Sharing
  • Presentation
January 31, 2017
CBI Clinical Data Disclosure and Transparency Conference
Return of Aggregate Results , Data Sharing
  • Publication
January 26, 2017
HHS Finalizes Comprehensive Revisions to the Common Rule
Data Sharing
  • Presentation
January 23, 2017
Clinical Trial Data Sharing
Data Sharing
  • Other
December 7, 2016
Introducing Vivli
Data Sharing
  • MRCT Sponsor Resource
  • Presentation
December 7, 2016
MRCT Center 2016 Annual Meeting Slides
Return of Individual Results , Data Sharing
  • Presentation
September 28, 2016
CDISC International Interchange
Data Sharing
  • Publication
May 11, 2016
A Global, Neutral Platform for Sharing Trial Data
Data Sharing
  • Presentation
May 6, 2016
A Vision from the MRCT Center to Promote Clinical Trial Data Sharing
Data Sharing
  • Presentation
May 3, 2016
Global Data Sharing and Transparency Initiatives
Data Sharing
  • Presentation
March 22, 2016
Future of Clinical Trial Data Sharing Transparency Slides Day 2
Data Sharing
  • Proceedings
March 21, 2016
Future of Clinical Trial Data Sharing Transparency
Data Sharing
  • Presentation
January 28, 2016
Responsible Clinical Trial Data Sharing
Return of Aggregate Results , Data Sharing
  • Presentation
January 28, 2016
Towards Streamlined Consent Processes and Participant Understanding
Data Sharing
  • Presentation
December 15, 2015
MRCT Center 2015 Annual Meeting Data Sharing Slides
Post-Trial Responsibilities , Data Sharing
  • Proceedings
December 15, 2015
MRCT Center Annual Meeting 2015
Global Clinical Trial Data Sharing , Post-Trial Responsibilities , Data Sharing
  • Presentation
November 12, 2015
FDLI Webinar Data Sharing Slides
Data Sharing
  • Presentation
November 3, 2015
Data Sharing Roundtable
Data Sharing
  • Presentation
September 28, 2015
Clinical Data Transparency Solutions for Sharing Participant Level Data
Data Sharing
  • Presentation
September 18, 2015
DIA Clinical Trial Data Sharing
Return of Aggregate Results , Data Sharing
  • Public Comments
September 7, 2015
Scientific Data – Editorial Comments
Data Sharing
  • Presentation
July 28, 2015
Executive and Steering Committee Meeting
Data Sharing
  • Proceedings
March 30, 2015
MRCT Center Promoting Clinical Trial Data Transparency Conference
Data Sharing
  • Presentation
March 30, 2015
MRCT Center Pre Conference Survey Slides
Global Regulatory Engagement , Data Sharing
  • MRCT Sponsor Resource
  • Tools
March 23, 2015
Informed Consent Form Word Template – No External Sponsor
Data Sharing
  • Framework
March 23, 2015
Informed Consent Template – No external Sponsor
Data Sharing
  • MRCT Sponsor Resource
  • Tools
March 23, 2015
Informed Consent Form Word Template – External Sponsor
Data Sharing
  • Framework
March 23, 2015
Informed Consent Template – External Sponsor
Data Sharing
  • Framework
March 1, 2015
Data Use Agreement
Data Sharing
  • Presentation
November 5, 2014
Data Sharing and Informed Consent
Data Sharing
  • Public Comments
September 11, 2014
Comments to Docket 2006-D-0031, Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
Data Sharing
  • Presentation
February 3, 2014
Guiding Principles for Clinical Trials 2014
Return of Aggregate Results , Data Sharing
  • Publication
October 24, 2013
Preparing For Responsible Sharing of Clinical Trial Data
Return of Aggregate Results , Data Sharing
  • Public Comments
September 30, 2013
Submission of comments on ‘Policy 0070 on publication and access to clinical-trial data’
Data Sharing
  • Public Comments
August 5, 2013
Comments to Docket No. FDA-2013-N-0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data
Data Sharing
  • Publication
July 17, 2013
EMA Draft Policy on Publication and Access to Clinical Trials Data Provides Broad Researcher Access to Participant-Level Data
Data Sharing
  • Presentation
May 17, 2013
Issues and Case Studies in Clinical Trial Data Sharing
Data Sharing
  • Proceedings
May 17, 2013
Issues and Case Studies in Clinical Trial Data Sharing
Data Sharing