| Autor: |
Nguyen L; PPD, Part of Thermo Fisher Scientific, Wilmington, North Carolina, USA., Leach A; Patient Safety Monitoring in International Laboratories (pSMILE), Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA., Piwowar-Manning E; HIV Prevention Trials Network LC, Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA., Marzinke M; HIV Prevention Trials Network LC, Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA., Levesque A; Westat, Rockville, Maryland, USA., Gregorio C; Westat, Rockville, Maryland, USA., Skinner K; Department of Surgery and Center for AIDS Research, Duke University Medical Center, Durham, North Carolina, USA., Towindo T; PPD, Part of Thermo Fisher Scientific, Wilmington, North Carolina, USA., Hanes H; Patient Safety Monitoring in International Laboratories (pSMILE), Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA., Sarpong K; Infectious Diseases Institute (IDI) Core Lab, Kampala, Uganda., Kasongo C; The Aurum Institute, Johannesburg, South Africa., Samsunder N; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Berea, South Africa., Aldrovandi G; International Maternal Pediatric Adolescent AIDS Clinical Trials and AIDS Clinical Trials Group, University of California, Los Angeles, California, USA., Ferbas KG; International Maternal Pediatric Adolescent AIDS Clinical Trials and AIDS Clinical Trials Group, University of California, Los Angeles, California, USA., Engelbrecht A; HIV Vaccine Trials Network LC, Cape Town, South Africa., Stirewalt M; HIV Vaccine Trials Network LC, Cape Town, South Africa.; HIV Vaccine Trials Network LC, Seattle, Washington, USA., Anyango E; Kenya Medical Research Institute, Nairobi, Kenya., Ubolyam S; HIV Netherlands Australia Thailand (HIV-NAT) AIDS Research Centre, Bangkok, Thailand., Lankford-Turner P; Emory Infectious Diseases Clinic Research Laboratory, Decatur, Georgia., Sarzotti-Kelsoe M; Patient Safety Monitoring in International Laboratories (pSMILE), Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA. |
| Abstrakt: |
The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide. |
