External & Regulatory Resources
DAIDS Regulatory Compliance Center (RSC)
Regulatory resources, including AE reporting manuals and forms, protocol registration materials, and toxicity tables, are available on the RSC website. There you will find the most current version of these resources, often with multiple format options. Some materials may be password protected.
Instructional videos have been posted to the RSC Website
How to Access Your Clinical Research Site (CRS) Profile Report through the DAIDS Protocol Registration System (DPRS) - view video
How to Modify Personnel at Your Site Using the DAIDS Adverse Experience Reporting System (DAERS) - view video
Financial Disclosure and Conflict of Interest Guidelines Standard Operating Procedure
Visit the HANC page for more details.
The ClinRegs website is designed to help the research community explore clinical research regulations within specific countries and compare regulatory requirements across countries.
FDA Financial Disclosure by Clinical Investigators
New Study-Specific FDA Financial Disclosure Form Issued
This form is based on the FDA Financial Disclosure by Clinical Investigators. All individuals listed on an FDA Form 1572 for an IMPAACT study conducted under an Investigational New Drug (IND) application with the US FDA must have on file at the site a completed financial disclosure form prior to enrollment of any participants in that study. Each CTS will follow-up with the study teams to complete these forms and to provide further instructions. View Sample Form
Other Regulatory Resources
FDA Forms - Contains multi-format versions of FDA forms, including 1572s.
Human Subject Protection Resources
Research Ethics Curriculum - A curriculum developed for international researchers conducting research that includes human participants and want to incorporate fundamental ethical considerations in the design and implementation of their research.
- WHO Guidelines for HIV
- WHO Guidelines for TB
- WHO Guidelines for Maternal, Reproductive and Women’s Health
- Antiretroviral Pregnancy Registry
NIAID and DAIDS Policies and Guidance Documents
- On Requirements for DAIDS Funded and/or Sponsored Laboratories in Clinical Trials Policy
- On Data and Safety Board Operations
- On Clinical Site Implementation and Operations
- On Clinical Research Event Reporting and Safety
- On Study Statuses and Milestones
- NIH Public Access Policy
- PubMed Central