DAIDS Regulatory Support Center - Regulatory Information


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What does the DAIDS/RSC Regulatory team do?

The Regulatory Team reviews Protocol Documents for regulatory compliance, and prepares and files new Investigation New Drug Applications (INDs) and amendments to existing INDs in compliance with the procedural and substantive requirements of 21 CFR § 312. Examples of submissions to the FDA include original IND Applications, Annual Reports, Safety Reports, and Responses to FDA Requests for Information.

	Regulatory Guidance - DAIDS HIPAA Policy

	DAIDS Policy # DWD-POL-CL-013.03, Expedited Adverse Event Reporting, dated 28 April 2010

	Latest DAIDS Policies and SOPs

	National Institutes of Health (NIH)
	NIH Revitalization Act of 1993

	NIH Brochure - Research on Human Specimens

	Guidance on Data and Safety Monitoring for Phase I and II Trials

	Notice to Grantees/Contractors re: FDA-NIH Interaction

	Guidelines on Inclusion of Women/Minorities as Clinical Research Subjects

	Required Education in Protection of Human Research Participants

	IND and Clinical Research Regulations and Guides
	21 CFR Part 312 - Investigational New Drug Application

	21 CFR Part 312.32 - IND Safety Reports

	21 CFR Part 54 - Financial Disclosure by Clinical Investigators

	FDA Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators

	International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice

	Human Subjects Protection
	The Belmont Report

	21 CFR Part 50 - Protection of Human Subjects

	45 CFR Part 46--Protection of Human Subjects

	2003 - Certificates of Confidentiality

	2003 - Guidance on Approving Research Involving Prisoners

	1997 - Storage of Tissue/Cell Repositories

	1988 - PHS Policy on Informing Those Tested About HIV Serostatus

	1984 - Guidance for Institutional Review Boards for AIDS Studies

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