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HPTN MOP Table of Contents

Introduction

Sections

  1. Overview

  2. HPTN Leadership

  3. HPTN Operational Components

  4. HPTN Working Groups, Committees, and Protocol Teams

  5. Community Participation in the HPTN

  6. Network Meetings and Communication

  7. Policies and Procedures

  8. Human Subjects Considerations

  9. Protocol Development

  10. Pre-Implementation, Site Activation, and Study Initiation

  11. Training

  12. Study Implementation

  13. Laboratory Issues

  14. Safety Considerations

  15. Study Oversight

  16. Monitoring

  17. Ancillary Studies/Investigations

  18. Study Close-out

Appendices

  1. HPTN 001-02: Manual of Operations Distribution and Modifications

  2. Protocol Deviation Form

  3. HPTN 011-03 Publication Policy

  4. HPTN 009-03: HPTN Operating Policies

  5. Study Visit Assessment Report Template

  6. HPTN 012-03: HPTN Financial Disclosure and Conflict of Interest Guidelines

  7. Material Transfer Agreement for Specimens from HPTN Clinical Trials

  8. HPTN 017-01: Release of HPTN Data from the SDMC

  9. Template Table of Contents for HPTN Study-Specific Procedures Manual

  10. HPTN 007-02: Overenrollment of HPTN Studies

  11. Guidelines and Examples on the SOAP Format for Chart Notes

  12. HPTN Laboratory Quality Assurance Policy

  13. HPTN Laboratory Quality Control Program

  14. HPTN Laboratory Assessment Checklist

Glossary