Our Resources include public comments, presentations, proceedings, articles and publications, reports and guidance documents, templates, and training materials.
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Type
Resource
Project
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Presentation
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Proceedings
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Publication
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Presentation
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Proceedings
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Training
October 22, 2024
Ethics and Review of Interventional Clinical Research
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Publication
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Publication
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Publication
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Presentation
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Proceedings
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Framework
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Framework
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Publication
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Framework
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Public Comments
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Framework
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Framework
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Presentation
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Proceedings
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Public Comments
August 22, 2022
Draft of New Drugs, Medical Devices and Cosmetics Bill
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Publication
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Training
June 1, 2022
IRB Health Literacy in Clinical Research
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Presentation
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Proceedings
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Training
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Publication
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Publication
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Publication
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Presentation
June 1, 2020
JTF Core Competency Framework Slides
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Framework
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Training
February 1, 2020
Interpretation and Application of ICH E6(R2) E-Learning
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Framework
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Publication
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Presentation
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Framework
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Framework
December 5, 2018
Core Competencies Leveling Summary Version 3.0
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Publication
December 3, 2018
The Evolving Regulatory Landscape for Clinical Trials in India
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Publication
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Public Comments
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Meeting Summary
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Proceedings
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Framework
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MRCT Sponsor Resource
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Public Comments
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Case Study
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Meeting Summary
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Presentation
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MRCT Sponsor Resource
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Presentation
October 26, 2015
ICH E17 Scientific and Regulatory Workshop Slides
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Publication
October 21, 2015
Indian Ministry Amends Informed Consent Rules
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MRCT Sponsor Resource
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Presentation
October 14, 2015
India: Progress and Opportunities
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Public Comments
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Public Comments
August 11, 2015
Comments to China FDA on resolving the backlog
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Publication
January 23, 2015
India’s Proposed Amendments to the Drug and Cosmetics Act
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Public Comments
January 11, 2015
Drugs and Cosmetics Amendment Bill Comments and Recommendations
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Presentation
December 3, 2014
Harvard MRCT India Regulatory Update, Causality and Compensation
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Publication
November 25, 2014
CT Regulation in India: Science of Social Justice?
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Publication
November 3, 2014
Clinical Trials, a Lost Opportunity for India
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Presentation
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Public Comments
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Publication
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Presentation
January 31, 2014
Harmonized Core Competencies for the Clinical Research Professional
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Proceedings