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HPTN Manual of Operations
&
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 March 2007.

HPTN Operating Policies

HPTN001	Manual of Operations Distribution and Modifications (Revised Aug 07) MOP Revision History Form
HPTN002	Selection/Expansion of Executive Committee Members (RETIRED)
HPTN003	Site Expansion for Performance Sites
HPTN004	HPTN Procedures for Responding to Initiation and Monitoring Visit Reports (RETIRED)
HPTN005	Testing Specimens Collected and Stored for Possible Future Research Testing in HPTN Studies (RETIRED) Notification of Testing of HPTN Stored Specimens for the HPTN PLG HPTN Material Transfer Agreement
HPTN006	Principal Investigator Initiated Termination of Participants from an HPTN trial
HPTN007	Over-enrollment and Under-enrollment in HPTN Studies
HPTN008	Site Expansion for Subsites Affiliated with Existing Performance Sites
HPTN009	HPTN Operating Policies
HPTN010	Site Access to Data During Conduct of a Trial (RETIRED, SUPERCEDED BY HPTN017)
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
HPTN012	HPTN Financial Disclosure and Conflict of Interest Guidelines (Revised Jun 08) Referenced Appendices for HPTN012:  HIV Prevention Trials Network Related Products and Manufacturers Guidelines for Completing Statement of Financial Equity and Patent Interests HIV Prevention Trials Network Statement of Financial Equity and Patent Interests See Other section below.
HPTN013	Participant Unblinding (Revised Aug 07)
HPTN014	Study Close-Out Sample Study Close-Out Checklist
HPTN015	Reporting of Protocol Events (RETIRED)
HPTN016	QA and Verification of HIV Test Results (RETIRED)
HPTN017	Release of HPTN Data from the SDMC (Revised Aug 07)
HPTN019	HIV Endpoint Determination (RETIRED)

Other

Central Lab HIV Status Verification Policy

Certification/Disclosure of Financial Interests and Arrangements of Clinical Investigators

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