Manual of Procedures

This Manual of Procedures (MOP) describes the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network structure; operating policies; roles and responsibilities of entities and individuals within the IMPAACT Network; protocol development and approval processes; site selection; process; standardized study operations procedures; data and specimen collection and processing procedures; and quality management, monitoring and evaluation of trials conducted by IMPAACT. The IMPAACT MOP is to be used as a reference document for current IMPAACT policies and procedures. Clinical Trial Units are expected to maintain a hard copy of the current IMPAACT MOP at all clinical research sites.

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

• If this Network MOP is inconsistent with the study-specific MOP, the study-specific MOP must be followed.
• If the study-specific MOP is inconsistent with the study protocol, the protocol must be followed.

IMPAACT 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 IMPAACT Operations Center Clinical Research Manager (CRM), the study-specific statistician and data manager, and the IMPAACT Laboratory Center (ILC) Quality Assurance/Quality Control Group.