These high-level policies define DAIDS' minimum requirements for the conduct of DAIDS' clinical research as defined in the scope of each policy to ensure compliance with applicable regulations, guidelines, and policies. These policies and other information serve as resources for DAIDS collaborators and staff for the Division's requirements for the conduct of DAIDS' clinical research.
DAIDS expects compliance with all applicable policies within 30 days of the “effective date” stated on each document unless otherwise defined.
Please note that as DAIDS policy documents undergo revisions and are transferred to the new DAIDS Quality Management System, they will be updated to high-level policies and the version numbering will begin with version 00 to mark the first version within the new quality system. The prior versions are archived.
Policies
- DAIDS Policy Table of Contents
- Event Reporting and Safety Monitoring
- Laboratory and Specimens Management
- Pharmacy and Study Products Management
- Protocol and Informed Consent Development
- Site Implementation and Operations
Resources
- COVID-19 Resources
- Glossary of DAIDS Terms
- List of Frequently Asked Questions
- NIAID Clinical Research Standards
- DAIDS TMF Manual