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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HPTN010 Site Access to Data During Conduct of a Trial (RETIRED, SUPERCEDED BY HPTN017)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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This page was last updated: July 30, 2008