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.
HPTN Protocol Deviation Reporting
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
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
FDA Forms - Contains multi-format versions of FDA forms, including 1572s.
Please forward suggestions for additions to this list to: firstname.lastname@example.org