Includes: Clinical Site Monitoring (CSM) system, DAIDS Adverse Event Reporting System (DAERS), DAIDS Protocol Registration System (DPRS), SiteHub, Protocol Management, and Master Contact
DAIDS Clinical Research Policies and Standard Operating Procedures Documents
The Difference Between Clarification Memos and Protocol Amendments In DAIDS-Sponsored Trials
DAIDS Regulatory Compliance Center (RSC)
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 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
NIH provides Certificates of Confidentiality automatically to any NIH-funded recipients conducting research applicable to the NIH Policy for Issuing Certificates of Confidentiality, for which all HPTN research is applicable. Certificates will be issued to recipients for applicable research regardless of the country where the investigator or the protected information resides. However, Certificates may not be effective for data held in countries outside of the US.
For more information on the CoC, refer to: https://grants.nih.gov/policy/humansubjects/coc.htm.
Other Regulatory Resources
FDA Forms - Contains multi-format versions of FDA forms, including 1572s.
International Federation of Pharmaceutical Manufacturers Association
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