OHRP Federal-Wide Assurance Application (FWA)
"Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions.
Institutional Review Boards and Informed Consent (46 CFR)
The IRB should ensure that all human subject research that is regulated by the Food and Drug Administration (FDA), and for which the IRB provides review and oversight, complies with FDA regulations at Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56).
NIDA Drug Supply Program (Chemistry & Physiological Systems Research Branch) provides chemicals and research probes that are either unavailable, difficult to obtain, or very expensive to buy to researchers. In addition, this program also provides analytical services for the analysis of researchers experimental samples.
For Reporting Serious Adverse Events (SAEs) and Adverse Events (AEs)
Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers - 1/15/2003 - (Text) (FDA Web Site)