Policies and standards are essential to any clinical research enterprise. In this regard, all clinical research funded and/or sponsored by NIAID must be compliant with these policies and standards in addition to the NIAID Clinical Terms of Award.
Division of Allergy, Immunology, and Transplantation (DAIT) Clinical Research Policies and Standards documents serve as resources for DAIT collaborators and staff, in addition to National Institutes of Health clinical research policies and 45 CFR 46, subparts B–D. Section 2 of each document, Scope, outlines the applicability of each policy and standard to different types of human subjects research (i.e., clinical research, observational research, or clinical trials).
DAIT expects compliance with all applicable policies within 30 days of the “effective date” stated on each document. DAIT may, at its discretion, request site monitors to spot-check documentation for compliance to these policies and procedures during monitoring visits.
- Requirements for Essential Documents at Clinical Research Sites Conducting DAIT Funded and/or Sponsored Clinical Research
- Requirements for Pharmacy Facilities at DAIT Supported Clinical Research Sites
- Requirements for Source Documentation in DAIT Funded and/or Sponsored Clinical Research
- DAIT Protocol Documents Template
Site Implementation and Operations
This section provides links to policies and standard procedures related to the implementation, monitoring, quality management, and training at clinical research sites conducting DAIT-supported and/or -sponsored clinical research.