Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework

Abstract

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.

Keywords: Clinical Trials; Collaboration; DAIDS GCLP Guidelines; GCLP audit; GCLP training; Laboratory Quality Improvement.

FIG. 1.

The figure includes a listing of commercial external quality assurance (EQA) providers used by the Division of AIDS Quality Assurance contractor to provide a customized approach to ensure the reliability of protocol-related tests. The bulleted text below each provider details the types of assays/methods/analytes tested for each. Also included in the table is the International Organization for Standardization accreditation obtained by each EQA provider.

FIG. 2.

The schematic diagram illustrates a clustered column chart with average agreement percentages of post-face-to-face Good Clinical Laboratory Practice training feedback aggregated from 342 respondents in 6 events conducted in 2023. Percentage of agreement for workshop content relevant to job or role is shown in blue. Percentage of agreement for new knowledge or skills gained from the workshop is shown in orange. The percentage of agreement that the workshop will contribute to their job performance is shown in gray.