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Collaborators

Collaborators 2010-06-17.gifHANC coordinates the efforts of a variety of individuals and organizations in order to set and meet objectives.

Network Laboratory and Operations Center Personnel

Each network (ACTG, IMPAACT, HPTN, HVTN and MTN) has one or more Network Laboratories, which perform the central processing for the network and support the activities of the more than 100 independent network-affiliated laboratories all over the world. In addition, some of the networks utilize the services of operation centers at Social and Scientific Systems, Inc. (SSS). Network Laboratory Principal Investigators (PIs) and Managers and key operation center personnel are extremely active members of most HANC-coordinated laboratory working groups and committees.

DAIDS Clinical Laboratory Oversight Team

The DAIDS Clinical Laboratory Oversight Team (DCLOT) is a cross-DAIDS team that includes staff from the Therapeutics Research Program (TRP), Vaccine Research Program (VRP) and Prevention Research Program (PSP). DCLOT’s purpose is to provide central guidance to DAIDS entities (e.g. OCSO, OPCRO, MO’s) in clinical laboratory matters, harmonize approaches to laboratory operations among DAIDS trial networks, provide a platform to discuss lab issues among DAIDS, network laboratory and operations center personnel and HANC, and optimize the use of DAIDS laboratory-related contractual resources. Key activities include:

  • Formulate and disseminate laboratory-related requirements to determine readiness of lab/site to open a trial and determine quality while trial is on-going.
  • Discuss and resolve issues related to:
    • Laboratory audits
    • Laboratory performance in External Quality Assurance programs
    • Backup labs
    • Instrument/kit validations
    • Assistance and training

Quality Assurance Contractors

DAIDS contracts with several quality assurance providers to conduct quality assessment for Network-affiliated laboratories:

The quality assurance contractors work with network laboratory personnel, operations center personnel, DCLOT and individual site-affiliated laboratories to ensure they are able to process quality specimens and generate reliable data for use in network studies. Their activities include:

  • Quality assurance (QA), which involves the management of all aspects of the testing process, including a broad spectrum of plans, policies and procedures which provide a structure whereby the laboratory can achieve quality data.  QA is brought about by the standardization of laboratory tests, the use of common reagents, the standardization of routine laboratory procedures, and evaluation of overall laboratory performance.
  • Quality control (QC) is comprised of techniques and procedures that monitor performance standards.  It usually includes various measurements that are used to monitor particular sources of errors, to estimate the magnitude of errors and to alert laboratory personnel to deteriorating quality.  QC is achieved by the production and distribution of standardized reagents and real-time check samples.
  • Quality assessment (also called proficiency testing (PT) or external quality assurance (EQA)) is achieved by supplying samples with known quantities to the laboratories, where they are tested in a manner similar to a study participant's specimens. The laboratories' results are compared to the known quantities. If a laboratory's results aren't sufficiently accurate, the program will proactively help a laboratory to determine the source of error so that the problem can be corrected.
  • Validation of new testing technologies.
  • Other laboratory-related activities such as training and personnel safety.

Statistical and Data Management Centers

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

SDMC personnel work with a variety of working groups to provide guidance for the statistical analysis of proficiency testing and study data or develop or modify systems for the management of data.

Laboratory Technicians

Laboratory technicians are the staff of the network site-affiliated laboratories that perform the actual testing or specimen processing. They provide invaluable insight into how policies and tools will affect everyday laboratory activities and inform their development.

Researchers

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.

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