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Lab Working Group Objectives and Activities
 
Laboratory Coordination Objectives for the Year 2018 are available here.​

 

​Objectives ​Example Activities

The Lab Focus Group (LFG) 

  •  Identify where economies of scale can be achieved by sharing resources, shared pricing agreements, technician training opportunities, laboratories, etc. and address these opportunities in existing or new working groups as necessary.
  • Identify and address opportunities to harmonize laboratory processes and procedures to reduce redundancy, increase efficiency and clarify expectations, especially at shared site laboratories.
  • Identify areas in lab operations and processes to incorporate principles of GCLP and ensure that data generated of highest quality, including but not limited to timelines, accuracy, and clinical appropriateness. GCLP guidelines will be reviewed in an annual basis.
  • Identify laboratory issues that require input from all the networks, in collaboration with DAIDS Clinical Laboratory Oversight Team (DCLOT), to assure that network labs are implementing quality and efficient lab processes.

 

  • Explore more inexpensive methods of obtaining IQA-approved quality fetal bovine serum (FBS) for distribution in African labs, especially South Africa.
  • Develop a cross network method for acute HIV diagnosis.

The ACTG/IMPAACT Laboratory Technologist Committee (LTC)

  • Promote uniform handling, processing, labeling, storage, and tracking of specimens (according to consensus procedures) across all clinical sites and laboratories; maintaining a regularly updated laboratory manual of consensus procedures readily available for access by all ACTG/IMPAACT laboratories.
  • Serve as a resource to the NIAID/Division of AIDS, Statistical and Data Analysis Center, Data Management Center, Operations Center, and Clinical Site Monitoring Group; acting as a liaison between site personnel, laboratories, clinics and the leadership of the ACTG/IMPAACT and its contractors as well as facilitating communication and networking among the laboratories, clinics and Data Management Center.
  • Provide information and education for laboratory personnel in the areas of protocol implementation, collection and regular export of quality data, regulatory requirements, new procedures and policies.

 

  • Share technical expertise and resolve laboratory issues including but not limited to assay/processing procedures, LDMS use, and laboratory operations. Topics may also include discussions on protocol complexity as well as upcoming novel/esoteric assays.
  • Reviews and updates harmonized laboratory standard operating procedures (SOP)s posted in the ACTG/IMPAACT Lab Manual.

 

The TB Laboratory Diagnostics Working Group (TBLDWG)

  • Serve as resource to network protocol teams.
  • Support institution of cross-network international specialty and regional TB laboratories.

 

  • Maintain a list of US and non-US labs with reliable TB diagnostic capacity.
  • Recommend new testing methods and assays when applicable to the conduct of clinical studies.
  • Recommend and implement relevant EQA and QC approaches to ensure the quality of study data.
  • Create and disseminate standard guidelines for sample collection, processing, transport, and diagnostics.
  • Support implementation of key elements in TB labs, including TB Sourcebook.
  • Support development and implementation of the TB Infection Control Training Module for Health Care Workers network clinical research sites engaged in TB research.

The Virology Quality Assurance Advisory Board (VQAAB)

  • Reviews data from external quality assurance (EQA) programs and provides input and guidance on new issues/ideas/programs identified by Virology Quality Assurance (VQA) program.
  • Provide an open forum for discussing new topics raised by members during monthly teleconferences.

 

  • Review and approve proposed scoring from VQA proficiency testing (PT) analyses which include programs for Quantitative HIV- RNA testing, Qualitative HIV-Total NA testing (whole blood), Qualitative HIV Total NA on Dried Blood Spots (DBS)), Genotypic HIV Drug Resistance testing for reverse transcriptase (RT), protease (PR) and integrase (INT) gene regions.
  • Establish monitoring standards that differentiate between missing data, transcriptional or computational errors, and technical problems.
  • Review and approve proposed changes in policies or procedures to promote quality assurance in virology assay testing.

The Clinical Pharmacology Quality Assurance (CPQA) :

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. erves 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 (CPQAAB)
  • The Regulatory Requirements Working Group (RRWG)
  • The CPQA HIV Monoclonal Antibodies and Small Molecule Tissue Pharmacology Working Group (CPQAmAb)
  • The CPQA Cross-Network Clinical Pharmacology Laboratory Forum (CNCPL Forum)
  • Bioanalytical Revision Assay Group (BRAG)
 
  • Draft a best practice document for DAIDS that summarizes the state of the art for collection, processing and bioanalysis of HIV broadly neutralizing antibodies and small molecule ARVs in tissue pharmacology protocols.​
  • Revising the CPQA AVR Assay method Guidelines to incorporate the changes made by the FDA, published in the draft version of the 2013 Bioanalytical Assay Validation Method Guidelines and consensus paper from the corresponding Crystal City meeting.

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