IMPAACT 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 Trials Specialist (CTS), the study-specific statistician and data manager, and the IMPAACT Laboratory Center (ILC) Quality Assurance/Quality Control Group.

The IMPAACT Network MOP is undergoing a complete reorganization; updated documents will be posted here as they become available.  More information and updated webpages will be posted to this website.  Please check back soon!

Manual of Procedures Sections

  Overview of IMPAACT Network  
  IMPAACT Leadership  
  IMPAACT Operational Components  
  IMPAACT Protocol Teams  
  Community Partnership, 3 October 2017  
  Network Meetings and Communication, 7 April 2017  
  General Policies and Procedures  
  Human Subjects Considerations  

Protocol Development and Modifications, 17 March 2017


Site Selection for IMPAACT Studies, 12 August 2016


Study Specific Pre-Implementation Activities, 31 January 2018

  • IMPAACT Template Site-Specific Activation Checklist, November 2017
  • IMPAACT Template Delegation of Duties Log, October 2017

    Study Implementation, 10 April 2017

  • IMPAACT Protocol Deviation Training, March 2017

    Study Oversight, 12 August 2016

      Study Close-out  

    Ancillary Studies and Investigations, 12 August 2016

  • IMPAACT Ancillary Studies Overview, June 2018
      Laboratory Considerations, 4 April 2018
  • MiPAL Site Lab Guide, 11 March 2018

    Network Evaluation, 12 August 2016


    Publications Requirements and Procedures, 31 July 2018


    Appendix I. Unblinding Procedures, 25 July 2018

  • IMPAACT 2018 Unblinding Training Webinar slides – 31 July 2018

    IMPAACT Network MOP Sections – 31 July 2018

    Training Materials and Resources

    Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.