HPTN Regulatory Resources
DAIDS Regulatory Compliance Center (RSC)
All HPTN-specific 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.
DAIDS SOPs
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DAIDS Clinical Research Policies and Standard Operating Procedures Documents
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The Difference Between Clarification Memos and Protocol Amendments In DAIDS-Sponsored Trials (Memorandum)
HPTN Protocol Deviation Reporting
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See Section 12.4.9 and Appendix 2 of the HPTN Manual of Operations
Financial Disclosure and Conflict of Interest Guidelines Standard Operating Procedure
The HANC-facilitated Financial Disclosure Working Group is
pleased to announce version 1.0 of the
“NIAID (DAIDS)-supported and/or Sponsored HIV/AIDS Clinical Trials Networks
Financial Disclosure
and Conflict of Interest Guidelines.” The guidelines are intended to
identify significant financial interests of network-affiliated researchers
and avoid conflicts of interest, or the appearance of such conflicts, in
activities of the networks. Network Leaders approved the guidelines on the
April 2010 Network Leaders call and the document has been adopted as
standard operating procedure (SOP) for all networks effective 15 April
2010.
Certificate of Confidentiality
The HPTN has been granted a certificate of confidentialty (COC) for the Network. Under the terms of the HPTN COC, each US site wishing to be covered under the certificate must request coverage for a specific study. An investigator interested in coverage under the HPTN should contact CORE staff for information on how to apply.
For background information on certificates of confidentiality, visit the NIH Certificates of Confidentiality Kiosk.
Other Regulatory Resources
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FDA Forms - Contains multi-format versions of FDA forms, including 1572s.
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International Federation of Pharmaceutical Manufacturers Association
Please forward suggestions for additions to this list to: hptn@fhi.org
