Registering a Site to a Protocol
Each CRS will complete the protocol registration process for all clinical research supported and/or sponsored by DAIDS that is reviewed by DAIDS Scientific Review Committees, namely the Prevention Sciences Review Committee (PSRC) and the Clinical Sciences Review Committee (CSRC), if it is determined that protocol registration is required. Upon receiving final IRB/EC and other applicable RE/Approving Entity approval(s), the CRS will submit all required registration documents to the DAIDS RSC PRO via the DPRS.
Enrolling Children in Clinical Research
Per the DAIDS Policy for Enrolling Children (including Adolescents) in NIAID (DAIDS)-supported and/or -sponsored Human Subject Clinical Research, for research studies including children or adolescents, DAIDS requires documentation of the IRB/EC designation of the pediatric risk or benefit category from the U.S. Federal regulations, 45 CFR 46.404-407 & 21 CFR 50.51-54 and IRB/EC approval for involvement of children based on the determination specified by that category.
IBC Oversight of Research with Recombinant DNA
Institutional Biosafety Committee (IBC)/Recombinant DNA Advisory Committee (RAC) Guidance
For more information, see the Protocol Registration process FAQs.