Certification/Disclosure of Financial Interests and Arrangements of Clinical Investigators
The HPTN form for Certification/Disclosure of Financial Interests and Arrangements of Clinical Investigators is required for all HPTN product studies (for both IND and non-IND product studies). This document should be completed and signed prior to study activation and filed in the central files and study files on site, per DAIDS Essential Document SOP and 21 CFR 312.53(c).
Certification/Disclosure of Financial Interests and Arrangements of Clinical Investigators form (Word document)
For more information on financial disclosure requirements, please reference 21 CFR 312.53(c), ICH E6 8.2.4, and the DAIDS Essential Documents SOP
Additional information and guidance on financial disclosure may be found at:
