The HPTN has four key standing Network oversight committees: the Science Review Committee (SRC), Study Monitoring Committee (SMC), Manuscript Review Committee (MRC), and the Performance Evaluation Committee (PEC).
Science Review Committee
The SRC is responsible for providing the HPTN Executive Committee (EC) with a thorough scientific, ethical and operational assessment of protocols. The SRC ensures that study protocols are statistically, operationally, and ethically sound as well as accurate, consistent, complete and, to the extent possible, standardized relative to other HPTN protocols.
Sten H. Vermund
Study Monitoring Committee
The SMC functions as an arm of the EC to provide a review of the conduct of all HPTN studies. Active HPTN studies are typically reviewed by the SMC within the first four to six months of study implementation and thereafter, approximately every six months including prior to Data and Safety Monitoring Board (DSMB) reviews. The Statistical and Data Management Center (SDMC) Principal Investigator (PI) in collaboration with HPTN Leadership will determine the need for and frequency of SMC reviews for each study.
Manuscript Review Committee
The MRC ensures that manuscripts containing data or statistically related content from HPTN studies are developed, reviewed, and endorsed for submission. The MRC is responsible for ensuring the timely development of manuscripts by the protocol team. It is responsible for the review (within five days of submission to the MRC) and provides written comments on the manuscript and specific rationale for any revisions requested. Reviews are conducted via conference calls on an as-needed basis upon manuscript submission. Conference calls are organized by the MRC Chair, Deborah Donnell.
Performance Evaluation Committee
The PEC is responsible for overseeing a continuous and comprehensive evaluation of the HPTN. The PEC designs and directs implementation and reporting of the internal evaluation of the HPTN. This includes assessing performance of the CTUs as well as key organizations and entities that are also part of the HPTN (e.g., Leaderships and Operations Center (LOC), SDMC, Laboratory Center (LC) and protocol teams).
The goal of the evaluation is to provide data to assist leadership in making any decisions or changes necessary to improve HPTN functioning. In regard to the CTUs, the primary purpose of the evaluation is to provide data to determine if the sites are contributing effectively to the protocols assigned and to elicit corrective action, if necessary, so that all sites are functioning at peak performance level.
Quarraisha Abdool Karim