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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:
http://www.fda.gov/cder/about/smallbiz/financial_disclosure.htm
and
http://www.fda.gov/oc/guidance/financialdis.html
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