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HPTN Manual of Operations

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Operating Policies

HPTN Manual of Operations

The Manual of Operations (MOP) describes the HIV Prevention Trials Network (HPTN) structure; operating policies; roles and responsibilities of entities and individuals within the HPTN; protocol development and approval processes; standardized study operations procedures; data and specimen collection and processing procedures; and quality management, monitoring, and evaluation in trials conducted by the HPTN. The HPTN MOP is to be used as a reference document for current HPTN policies and procedures. All sections in the current issue of the MOP are dated June 2010.

HPTN Operating Policies

The following HPTN Operating Policies were retired and incorporated into the June 2010 version of the HPTN MOP.

HPTN001	Manual of operations Distribution and Modification (see Introduction to the HPTN Manual of Operations)
HPTN012	Financial Disclosure and Conflict of Interest (see Section 7.2 of HPTN Manual of Operations)
HPTN014	Study Close-out (see Section 18 of HPTN Manual of Operations)
HPTN017	Release of Data from the SDMC (see Section 12.5 of HPTN Manual of Operations)
	Operating and Other Policies still in affect
HPTN009	HPTN Operating Policies
HPTN011	HPTN Publication Policy Appendix A: International Committee of Medical Journal Editors "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publications" Section II.A "Authorship and Contributorship" Appendix B: Guidance on Acknowledgment of Support for Manuscripts resulting from HPTN-funded Studies Appendix C: HPTN Prevention Management Group Notification of Testing Form for HPTN Stored Specimens Appendix D: List of HPTN-related Cooperative Agreements
Other	Central Lab HIV Status Verification Policy