DAIDS PUBLIC COMMENT PERIOD: Protocol Registration Manual and Policy
The Division of AIDS seeks your input on the updates to the DAIDS Protocol Registration Manual and Policy. This policy and manual describes the protocol registration requirements for National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS)-supported and/or -sponsored clinical research that is reviewed and approved by a DAIDS Scientific Review Committee.
The manual and policy have been reviewed for accuracy and updated to meet 508 compliance guidelines. Several sections of the manual have been updated to be consistent with current NIAID (DAIDS) requirements. Key changes to note in this version of the manual include:
- DAIDS requirement of Protocol Signature Page (PSP) to document the commitment of the Investigator of Record (IoR) to conduct the trial in compliance with regulations/Laws.
- The requirement to submit translation certificate (or translation documentation) for local language documents.
- Clarification regarding staff that must be listed on the Form FDA 1572 an/or DAIDS IoR Forms in compliance with U.S. regulations and ICH E6 standards.
- Information regarding protocol specific Delegation of Duties logs.
- Formatting changes and hyperlinks added to improve navigation of the manual. The policy and manual are available at the links above.
Please submit comments via email by December 11, 2017. Include the following information: the name of the document, line number(s) and/or section number that corresponds. Comments will only be accepted in the specified format.
Division of AIDS Policies
Policies and procedures are essential to any clinical research enterprise. In this regard, the Division of AIDS (DAIDS) has standardized and harmonized operational procedures across research. Accordingly, all human subjects research supported and/or sponsored by NIAID must be compliant with these policies and standard operating procedures in addition to the NIAID Clinical Terms of Award; all National Institutes of Health (NIH) clinical research policies; and 45 CFR 46, subparts B-D. These documents also serve as resources for DAIDS collaborators and staff to refer for division requirements on the conduct of DAIDS research.
The applicability of each policy and standard operating procedure to different types of human subject research (i.e., clinical research, observational research, or clinical trials) is outlined in the document’s statement of Scope.
DAIDS expects compliance with all applicable policies and procedures within 30 days of the “effective date” stated on each document. DAIDS may, at its discretion, request the Clinical Site Monitoring Group (CSMG) monitors to spot-check documentation for compliance to these policies and standard operating procedures during monitoring visits.
- Event Reporting and Safety Monitoring
Links to policies and standard procedures relating to the reporting and monitoring of study progress and safety in DAIDS-funded and/or -sponsored clinical trials.
- Laboratory and Specimens Management
Links to policies and standard procedures relating to requirements for laboratories associated with DAIDS-funded and/or -sponsored clinical trials.
- Pharmacy and Study Products Management
Links to policies and standard procedures relating to requirements for pharmacies associated with DAIDS-funded and/or -sponsored clinical trials.
- Protocol and Informed Consent Development
Links to policies and standard procedures relating to the content of protocol and informed consent documents for DAIDS-funded and/or -sponsored clinical research.
- Site Implementation and Operations
Links to policies and standard procedures relating to site operations, monitoring, quality management, and training at clinical research sites conducting DAIDS-funded and/or -sponsored clinical research.
- Glossary of DAIDS Terms
(Currently under revision)
Definitions of clinical research terms used by DAIDS.
- DAIDS Clinical Research Policy Archive
These documents are accessible to the public for reference purposes and should not be regarded as reflecting current U.S. Department of Health and Human Services or DAIDS policy.
- List of DAIDS Acronyms
- List of Frequently Asked Questions
A list of Frequently Asked Questions (FAQs) and DAIDS responses.