DAIDS Regulatory Compliance Center - Safety and Pharmacovigilance


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What does the DAIDS/RCC Safety and Pharmacovigilance team do?

The RCC Safety team receives adverse events reported by sites participating in DAIDS-supported studies, processes the events for review by the DAIDS Medical Officer, and prepares the reports for submission to the Food and Drug Administration (FDA), if required. They work closely with the OPCRO Safety and Pharmacovigilance Team (SPT) to establish internal procedures and develop Safety and EAE training for the clinical research sites.

	DAIDS Adverse Event Grading Tables Current:
	Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0 - December 2004 (Clarification dated August 2009)

	Memo Regarding the Clarification to the Table for Grading Severity of Adult and Pediatric Adverse Events

	Addendum 1-Female Genital Grading Table for Use in Microbicide Studies

	Addendum 2-Male Genital Grading Table for Use in Microbicide Studies

	Addendum 3-Rectal Grading Table for Use in Microbicide Studies

	Previous:
	Table for Grading Severity of Adult Adverse Experiences August 1992

	Table for Grading Severity of Pediatric Adverse Experiences less than 3 months of age April 1994

	Table for Grading Severity of Pediatric Adverse Experiences greater than 3 months of age April 1994

	Expedited Reporting Manual Current:
	Manual for Expedited Reporting of Adverse Events to DAIDS Final 1.0, 6 May 2004

	Previous:
	SAE Reporting Manual - HPTN 1 Jun 2001

	SAE Reporting Manual - HVTN 15 Nov 2000

	SAE Reporting Manual - ACTG, AIEDRP, CPCRA, IMPAACT, and IRP 1 Aug 1998

	Expedited Reporting of AEs Electronic Reporting - DAERS:
	Site Users Guide

	Frequently Asked Questions (FAQs)

	Administrative

	DAERS URL - https://daidses.niaid.nih.gov/phoenix/Login.aspx

	DAERS IT Help - DAIDSESSupport@niaid.nih.gov

	DAERS Reporting Help - RCCSafetyOffice@tech-res.com

	DAERS Emergency Information - Frequently Asked Questions

	Updating Your Site's DAERS Users

	Instructions for Completion of DAERS User Information Sheet and Physician Attestation and Agreement for Electronic Signature Documents

	DAERS User Information Sheet

	Physician Electronic Signature Attestation Form

	DAERS System for Submission of EAE Information 30 January 2008

	Paper Reporting: Current:
	Division of AIDS Safety Office Expedited Adverse Event (EAE) Form Version 1.1, 25 Oct 2004

	Completion Instructions for the DAIDS EAE Form Final 1.0, 25 Oct 2004

	Previous:
	SAE Form - HPTN 6 July 2004

	SAE Form - HVTN 6 July 2004

	SAE Form - ACTG, AIEDRP, CPCRA, IMPAACT, and IRP 6 July 2004

	Training
	Safety Workshop Basic Principles

	Safety Workshop EAE Module

	EAE Core Slide Set

	DAERS Training Slide Set

	Administrative

	Training Resource Information Memo

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