Laboratory

Supporting Laboratory Working Groups and Committees

HANC supports several cross-network laboratory working groups and committees with the aim of harmonizing processes and procedures, ensuring standard quality assurance for protocol-specified assays, and ensuring laboratory preparedness for network clinical trials.

Working Groups and Committees

HANC coordinates the Lab Focus Group and provides support to the ACTG/IMPAACT Lab Technologist Committee and the DAIDS EQA Provider Working Groups.

Objectives

Laboratory Coordination Work Plan

Expand All

The ACTG/IMPAACT LTC is a joint ACTG/IMPAACT committee. Voting members serve on protocol teams and provide those teams with technical expertise in the development of the laboratory components of protocols as well as standardizing the handling, processing, labeling, and storage of clinical specimens across all ACTG/IMPAACT clinical sites and laboratories. The LTC also posts resources, including the ACTG/IMPAACT Laboratory Manual.

The Lab Focus Group (LFG) is comprised of Network Laboratory Leadership and management staff. It oversees all cross-network laboratory activities, including policy and process development and follow-up work to complete cross-network projects and tasks that address laboratory training, operations, and support issues.

The PBMC SOP Working Group is charged with developing, publishing and reviewing the Cross-Network PBMC Processing SOP for all network-affiliated labs that process PBMC.

The current version of the SOP in English, Spanish, Portuguese, and Thai are posted and available on the Cross-Network PBMC Processing SOP page.

The Virology Quality Assurance Advisory Board (VQAAB) serves as an external group that reviews data generated for the Virology Quality Assurance (VQA) proficiency testing programs, provides input and guidance on new issues/ideas/programs, and provides an open forum for discussing new topics raised by other VQAAB members during monthly teleconferences.

The VQAAB is comprised of non-voting representatives from the VQA Laboratory, the VQA Data Management Group, the VQA Statistical Analysis Group, DAIDS, the Statistical & Data Analysis Center, and a voting representative from each of the respective NIH-funded HIV Research networks.

CPQA Advisory Board

The Clinical Pharmacology Quality Assurance (CPQA) program serves as a forum for the networks to communicate their pharmacology quality assurance needs to the CPQA program, and provides oversight for the activities of the CPQA. The CPQA Advisory Board includes the directors of the Network Pharmacology Specialty Laboratories, DAIDS, statisticians, the CPQA and other experts who meet during monthly teleconferences.

Cross-Network Clinical Pharmacology Laboratories Forum (CNCPL Forum)

Cross Network Clinical Pharmacology Laboratories Forum is composed of technical representatives from each network pharmacology laboratory (supervisors, technicians) and an open forum facilitating communications between the CPQA program and pharmacology laboratories.

Partnerships

HANC works with a variety of partners to create a more integrated and collaborative approach to laboratory operations across the NIH-funded HIV/AIDS Clinical Trials Networks. These partners include:

Expand All

The DAIDS Clinical Laboratory Oversight Team (DCLOT) is a cross-DAIDS team who provide central guidance to DAIDS entities on clinical laboratory matters, harmonize approaches to laboratory operations among DAIDS trial networks, and optimize the use of DAIDS laboratory-related contractual resources.

The HIV/AIDS Clinical Trials Networks Laboratories work to continually improve the quality and efficiency of protocol-related testing under a laboratory Total Quality Management (TQM) Program. The TQM Program is supported by representatives from the DAIDS Clinical Laboratory Oversight Team and the network laboratory centers and QA/QC contractors.

The quality assurance providers conduct quality assurance, quality control, quality assessment (proficiency testing and external quality assurance), validation, and training for Network-affiliated laboratories:

Clinical Pharmacology Quality Assurance (CPQA) for testing of antiretroviral drug levels in the blood, spinal fluid, or tissue
External Quality Assurance Program Oversight Laboratory (EQAPOL) for the characterization of viral diversity
Immunology Quality Assurance (IQA) for the integrity and usefulness of blood samples after PBMC cryopreservation
Patient Safety Monitoring and International Laboratory Evaluation (pSMILE) for patient safety
United Kingdom National External Quality Assessment Service (UK NEQAS) for immunology
Virology Quality Assurance (VQA) for the measurement of HIV levels

The statistical and data management centers (SDMCs) collect and analyze the scientific data that is generated by the laboratories for clinical trials.

Laboratory technicians (LTs) perform highly technical biological specimen testing in the network-affiliated lab sites and provide invaluable insight into the development of policies and procedures that affect critical, on-the-ground laboratory activities.

Researchers are members of protocols teams who drive the development and implementation of network studies. They provide invaluable subject area expertise to the various working groups and committees.