Manual of Operations

This 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 of trials conducted by the HPTN. The HPTN MOP is to be used as a reference document for current HPTN policies and procedures. Clinical Trial Units are expected to maintain a hard copy of the current HPTN MOP at all clinical research sites.

The HPTN MOP does not replace the study-specific procedures (SSP) manual that is developed for each HPTN study. The SSP contains detailed guidance on study implementation. All study procedures within the HPTN must be conducted in accordance with the study protocol, the SSP manual, and this MOP. In the event that there are inconsistencies between these documents, the precedence that must be followed is:

  • If the MOP is inconsistent with the SSP, the SSP must be followed.
  • If the SSP is inconsistent with the study protocol, the protocol must be followed.


HPTN members are encouraged to contact the relevant individuals within the Network with procedural questions. For study-specific questions related to proper implementation, data collection, and laboratory concerns for a study protocol, contact the HPTN Leadership and Operations Center (LOC) Clinical Research Manager (CRM), the HPTN Statistical and Data Management (SDMC) Project Manager (PM), and the HPTN Laboratory Center (LC) Quality Assurance/Quality Control Coordinator.

Combined file with all MOP Sections

Section 1: Overview

Section 2: HPTN Leadership

Section 3: HPTN Operational Components

Section 4: HPTN Working Groups, Committees, and Protocol Teams

Section 5: Community Participation in the HPTN

Section 6: Network Meetings and Communication

Section 7: HPTN Funding, Conflict of Interest and Certificate of Confidentiality

Section 8: Human Subjects Considerations

Section 9: Protocol Development

Section 10: Study Specific Pre-Implementation, Site Activation, and Study Initiation

Section 11: Training

Section 12: Study Implementation

Section 13: Laboratory Component

Section 14: Safety Considerations

Section 15: Study Oversight

Section 16: New Site Requirements

Section 17: Ancillary Studies/Investigations

Section 18: Clinical Research Site Study Specific Close-out

Section 19: Network Evaluation

Section 20: Selection of Sites

Section 21: Publications Policy

 

Ancillary Study

Application Form

Laboratory Center Resources Form

Leadership and Operations Center Resources Form

Proposed Activity Form

Statistical and Data Management Center Resources Form

 

Site Selection

Site Selection Committee Scoring Examples

Site Selection Scoring - MSM study Examples

Template for Site Questionnaire

DAIDS Site Expansion Information Sheet

 

Protocol/Concept Template

HPTN Protocol Template

Clarification Memo Template

Letter of Amendment Template

Summary of Changes Template

 

Other

HPTN PI Agreement

Confidentiality Agreement

Financial Disclosure Form

HPTN Laboratory Assessment Checklist

HPTN Network Laboratory Assessment Visit Report Form

Material Transfer Agreement

Procedure: Quality Assurance Policy/Quality Assessment Policy

Quality Control Policy

SOAP Example for Chart Notes

Study Specific Procedure Manual Table of Contents Template

Study Closeout Checklist Sample

HPTN Concept Template

HPTN Critical Event Reporting Form

SSP Section Template

Publication Guidance and Request Document