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.

Manual of Procedures Sections

Combined file with all MOP sections, May 2019

IMPAACT Network MOP Overview of Section Contents and Identification of Current Section Versions, May 2019

  Overview of IMPAACT Network, Version 2.1, 31 May 2019  
  Network Groups, Version 2.0, 12 April 2019    
  IMPAACT Operational Components  
  IMPAACT Protocol Teams, Version 2.1, 31 May 2019  
  Community Partnership, Version 2.0, 20 November 2018  
  Network Meetings and Communication, Version 2.0, 20 November 2018  
  General Policies and Procedures  
  Human Subjects Considerations, Version 2.0, 20 November 2018  

Protocol Development and Modifications, Version 2.0, 20 November 2018


Site Selection for IMPAACT Studies, Version 2.0, 20 November 2018


Study Specific Pre-Implementation Activities, Version 2.0, 20 November 2018

  • IMPAACT Template Site-Specific Activation Checklist, November 2017

    Study Implementation, Version 2.1, 31 May 2019

  • IMPAACT Protocol Deviation Training (for sites), March 2017
  • IMPAACT Protocol Deviation Training (for Clinical Site Monitors), September 2019
  •     >> View video of webinar presentation

    Study Oversight, Version 2.1, 31 May 2019

      Study Close-out  

    Ancillary Studies and Investigations, 12 August 2016

  • IMPAACT Ancillary Studies Overview, June 2018
      Training, Version 2.0, 20 November 2018  
      Laboratory Considerations, Version 2.0, 20 November 2018
  • MiPAL Site Lab Guide, 11 March 2018

    Network Evaluation, Version 2.0, 20 November 2018


    Publications Requirements and Procedures, 31 July 2018


    Appendix I. Unblinding Procedures, Version 2.0, 10 December 2018

  • IMPAACT 2018 Unblinding Training Webinar slides – 10 December 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.