HIV Prevention Trials Network

Manual of Operations

March 2007

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 (see Appendix 9: Template Table of Contents for HPTN Study-Specific Procedures Manual). All study procedures within the HPTN must be conducted in accordance with the study protocol, the study-specific procedures (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 and data collection for a study protocol, contact the HPTN Coordinating and Operations Center (CORE) Clinical Research Manager/Protocol Specialist (CRM/PS) and the HPTN Statistical and Data Management (SDMC) Project Manager (PM).