The Regulatory Support Center (RSC) plays a key role in supporting a wide range of clinical research activities and programs administered by the Office for Policy in Clinical Research Operations (OPCRO), of the Division of AIDS (DAIDS). DAIDS is a major component of the National Institute of Allergy and Infectious Diseases (NIAID). The majority of the NIH research effort related to HIV infection and AIDS is managed by the NIAID.
The primary mission of the RSC is to provide regulatory support for all domestic and international clinical research programs supported by DAIDS and maintain an electronic database to schedule, track, report, store, modify, transmit, and process all regulatory work and work products related to this important research effort. This data system is part of the DAIDS Enterprise System (ES) that supports many of the clinical research management and oversight responsibilities of NIAID/DAIDS. The ES enables the RSC to exchange information directly with computer database systems utilized by the DAIDS-sponsored Group/Network Operations Offices, Data Management Centers, and other collaborators to assure efficient and effective integration of regulatory information in support of NIAID/DAIDS.
In addition to this critical MIS mission, the RSC maintains a reliable, efficient, and secure Internet Web Portal that serves as an information source for DAIDS staff and Investigator Group members and their associated staff anywhere in the world with Internet access. This RSC Portal provides easy access to all guidance documents, manuals, templates, forms and documentation related to regulatory issues of importance in DAIDS-sponsored clinical studies.
What does the 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 ยง 312. Examples of submissions to the FDA include original IND Applications, Annual Reports, Safety Reports, and Responses to FDA Requests for Information.
What does the RSC Human Subjects Protection Team do?
The RSC Human Subjects Protection (HSP) Team is responsible for reviewing all Informed Consents (ICs) during review at the P/CSRC, Regulatory Review, and Protocol Registration. These include ICs for DAIDS-sponsored network and investigator-initiated protocols supported through DAIDS' grants. The HSP Team is responsible for the translation of Sample ICs to Spanish.
What does the RSC Protocol Registration Team do?
The process of completing and submitting the informed consent, IRB/EC approval letter, FDA 1572 Form, and Investigator of Record C.V. is called Protocol Registration. Protocol registration may occur more than once during the course of the protocol. Subsequent protocol registrations are called amendment registrations.
What does the RSC Safety and Pharmacovigilance Team do?
The RSC Safety Team collects 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 transmittal 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 training for the clinical research sites.
What does the RSC Case Report Form Management Team do?
As part of the closeout process, sites send their case report forms (CRFs) to RSC for storage. The CRF team at RSC reviews the submitted documents before transporting them to a storage facility.
What does the RSC Clinical Study Information Office do?
The DAIDS Clinical Study Information Office (CSIO) at the RSC receives and abstracts protocol and/or contact information into the DAIDS-Enterprise System (DAIDS-ES) for use by the NIAID/DAIDS and their collaborators in support of DAIDS-supported and/or sponsored clinical trials.