Public Comments
Comments provided on: July 20, 2020
Comments provided to: Food and Drug Administration (FDA)
Language: English
Response to FDA’s request for comments on strategic priorities for the Office of Minority Health and Health Equity (OMHHE)
Public Comments
Comments provided on: June 29, 2020
Comments provided to: Food and Drug Administration (FDA)
Observational Patient Evidence for Regulatory Approval and understanding Disease (OPERAND)
Presentation
Presented on: June 18, 2020
Presented by: Barbara E. Bierer, MD
Presented at: DIA 2020 Virtual Global Annual Meeting
Communicate and co-create with patients across the medicines development lifecycle: Principles and best practices
Presentation
Presented on: June 18, 2020
Presented by: Sylvia Baedorf Kassis
Presented at: DIA 2020 Virtual Global Annual Meeting
Issues in the registration of database studies
Publication
Published on: January 20, 2020
Published in: Journal of Clinical Epidemiology
Response to European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR)
Public Comments
Comments provided on: April 29, 2020
Comments provided to : European Commission
Writing and Design Workshop for Research and Practice
Presentation / Video
Presented on: April 17, 2020
Presented by: Sylvia Baedorf Kassis
Presented at: Tufts University School of Medicine Plain Language Workshop
Time for NIH to lead on data sharing
Publication
Published on: March 20, 2020
Published in: Science
Disruptive and Avoidable: GDPR Challenges to Secondary Use of Data
Publication
Published on: March 2, 2020
Published in: European Journal of Human Genetics
Leveled Core Competency Framework for the Clinical Research Professional Version 3.1 (English)
Framework
Released in: February 2020
Developed by: Joint Task Force for Clinical Trial Competency
