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

1.
  Overview of IMPAACT Network  
2.
  IMPAACT Leadership  
3.
  IMPAACT Operational Components  
4.
  IMPAACT Protocol Teams  
5.
  Community Partnership  
6.
  Network Meetings and Communication  
7.
  General Policies and Procedures  
8.
  Human Subjects Considerations  
9.
 

Protocol Development and Modifications, 12 August 2016

 
10.
 

Site Selection for IMPAACT Studies, 12 August 2016

 
11.
 

Study Specific Pre-Implementation Activities, 12 August 2016

 
12.
 

Study Implementation, 4 January 2017

 
13.
 

Study Oversight, 12 August 2016

 
14.
  Study Close-out  
15.
 

Ancillary Studies and Investigations, 12 August 2016

 
16.
  Training  
17.
  Laboratory Considerations  
18.
 

Network Evaluation, 12 August 2016

 
19.
 

Publications Requirements and Procedures, 9 February 2017

Appendix I. Unblinding Procedures, Final Draft, 12 August 2016

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.