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

1.
  Overview of IMPAACT Network, Version 2.1, 31 May 2019  
2.
  Network Groups, Version 2.0, 12 April 2019    
3.
  IMPAACT Operational Components  
4.
  IMPAACT Protocol Teams, Version 2.1, 31 May 2019  
5.
  Community Partnership, Version 2.0, 20 November 2018  
6.
  Network Meetings and Communication, Version 2.0, 20 November 2018  
7.
  General Policies and Procedures  
8.
  Human Subjects Considerations, Version 2.0, 20 November 2018  
9.
 

Protocol Development and Modifications, Version 2.0, 20 November 2018

 
10.
 

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

 
11.
 

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

  • IMPAACT Template Site-Specific Activation Checklist, November 2017
  • IMPAACT Template Delegation of Duties Log, October 2017
  •  
    12.
     

    Study Implementation, Version 2.1, 31 May 2019

  • IMPAACT Protocol Deviation Training, March 2017
  •  
    13.
     

    Study Oversight, Version 2.1, 31 May 2019

     
    14.
      Study Close-out  
    15.
     

    Ancillary Studies and Investigations, 12 August 2016

  • IMPAACT Ancillary Studies Overview, June 2018
  •  
    16.
      Training, Version 2.0, 20 November 2018  
    17.
      Laboratory Considerations, Version 2.0, 20 November 2018
  • MiPAL Site Lab Guide, 11 March 2018
  •  
    18.
     

    Network Evaluation, Version 2.0, 20 November 2018

     
    19.
     

    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.