DAIDS Regulatory Support 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.
Please see https://rsc.niaid.nih.gov/clinical-research-sites/summary-resources for additional resources for Clinical Research Sites.
DAIDS Clinical Site Implementation and Operations
This page provides links to policies and standard operating procedures related to the implementation, monitoring, quality management, and training at clinical research sites conducting DAIDS-supported and/or -sponsored clinical research: https://www.niaid.nih.gov/research/daids-clinical-site-implementation-operations.
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
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. More information of IMPAACT Network policies and procedures for financial disclosure can be found in the Network Manual of Procedures, Section 7.
Other Regulatory Resources
- FDA Forms - Contains multi-format versions of FDA forms, including 1572s.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Website
- International Federation of Pharmaceutical Manufacturers & Association Website
Human Subject Protection Resources
- Office for Human Research Protections
- OHRP Policy and Guidance
- OHRP FAQs
- 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.
- Certificate of Confidentiality (CoC) is deemed issued under the IMPAACT Network NIH award. Documentation of NIH funding or support, the NIH CoC Policy (NOT-OD-17-109), the NIH Grants Policy Statement (See 18.104.22.168), and subsection 301(d) of the Public Health Service Act, serve as documentation of the issuance of a Certificate for a specific study. More information of IMPAACT Network certificate of confidentiality can be found in the Network Manual of Procedures, Section 7.
- 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
- Requirements for DAIDS Funded and/or Sponsored Laboratories in Clinical Trials Policy
- Data and Safety Board Operations
- Clinical Site Implementation and Operations
- Clinical Research Event Reporting and Safety
- Study Statuses and Milestones
- NIH Public Access Policy
- PubMed Central
- New Pharmacy Operations Monitoring Assessment (Dec 2019)