DAIDS Regulatory Support Center - Safety and Pharmacovigilance


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Safety Information pertains to the safety profile of study agents (drug, vaccine, or device) and is intended for use by the clinical research sites that are involved in DAIDS-sponsored/supported studies. Information conveyed through the DAIDS RSC Safety Information Center (RIC) comes from drug company collaborators (Investigator Brochures and Package Inserts), from findings in DAIDS studies (IND safety reports and MedWatch reports), from studies being conducted by the pharmaceutical company using the same study agent as in a DAIDS-sponsored/supported study (Safety Memos), as well as publicly available safety information (Safety Alerts and Safety Notices).

Distribution of safety information is part of sponsor’s responsibilities in accordance with 21 CFR 312.32 and 21 CFR 312.55 as well as DAIDS policies and procedures.

The DAIDS Safety Information Resources memo and the new DAIDS RSC Safety Information Web page clarify safety information distributed through the DAIDS Regulatory Support Center (RSC). The DAIDS RSC Safety Information Center processes and distributes safety information on behalf of DAIDS under the oversight of the DAIDS Safety and Pharmacovigilance Team (SPT).

Safety Information Type Distributed by DAIDS

This table summarizes ALL types of safety information distributed by RIC. It also provides information on the format of distributions and to whom information is sent. NOTE: Safety Information is ONLY distributed to a DAIDS-approved distribution list which includes site leaders/CTU PIs, site/CTU coordinators and IoRs from relevant sites as well as the DAIDS Medical Officers and the Operations Centers.

	Package Insert (PI) Information prepared by the manufacturer of a drug. (see table for more information)

	Package Insert - Distribution Email

	Investigator Brochure (IB) Information prepared by the manufacturer about a study agent under clinical development, either not yet approved by the FDA or being investigated for other uses. (see table for more information)

	Investigator Brochure - Distribution Email

	IND Safety Reports and MedWatch Reports A safety report written by DAIDS and submitted to the FDA, notifying the agency that a serious adverse event (SAE) meeting reporting criteria has occurred on a study sponsored/supported by DAIDS. (see table for more information)

	IND Safety Report - Distribution Email

	MedWatch Report - Distribution Email

	Safety Memo A safety report prepared by the drug company and submitted to the FDA notifying the agency that a reportable event has occurred on a drug company-sponsored study, which is provided to DAIDS for distribution to sites. (see table for more information)

	Safety Memo - Distribution Email

	Safety Alert Safety information that DAIDS has determined to be of sufficient concern to warrant expedited distribution to sites. (see table for more information)

	Safety Alert - Distribution Email

	Safety Notice Publicly available safety information that DAIDS has determined to be of sufficient concern to warrant distribution to sites, but does not need to be distributed in an expedited timeframe. (see table for more information)

	Safety Notice - Distribution Email

	Data and Safety Monitoring Board (DSMB) Memo A memo from the DAIDS Biostatistics Research Branch (BSB) containing the decision of the DSMB following a review of a particular protocol. (see table for more information)

	DSMB Memo - Distribution Email

	Monthly Comprehensive Safety Distribution Report A monthly report listing all safety information types that were distributed to sites by the DAIDS RSC Safety Information Center (RIC) during the previous twelve (12) month period. (see table for more information)

	Comprehensive Safety Distribution Report - Distribution Email

Safety Information Resources

	Safety Information Resource Memo

	RSC Safety Information Center - Frequently Asked Questions

	RSC Safety Information Contacts

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