An Integrated DAIDS Laboratory Oversight Framework: Application of the DAIDS GCLP Guidelines.

Area of Science:

• Clinical Laboratory Science
• Regulatory Compliance
• Global Health Research

Background:

• The Division of AIDS (DAIDS) established Good Clinical Laboratory Practice (GCLP) Guidelines to ensure quality in laboratories supporting clinical research.
• Effective laboratory oversight is critical for data integrity, participant safety, and regulatory adherence in clinical trials.

Purpose of the Study:

• To describe the application of DAIDS GCLP Guidelines and the Integrated Laboratory Oversight Framework.
• To assess laboratory staff experiences with GCLP implementation through surveys in 2017 and 2023.
• To identify areas for improvement in laboratory oversight and GCLP implementation.

Main Methods:

• Analysis of data from two self-administered online surveys (2017, 2023) of laboratory staff.
• Description of the DAIDS Integrated Laboratory Oversight Framework and collaborative oversight team efforts.
• Monitoring of over 175 participating laboratories worldwide.

Main Results:

• Survey results informed changes in GCLP audit activities and promoted harmonization in laboratory oversight.
• A key finding is the preference for hybrid GCLP training (face-to-face and online modules).
• Both surveys indicated satisfaction with GCLP implementation but noted a need for improved dissemination of oversight requirements.

Conclusions:

• The collaborative oversight approach and integrated framework enhance knowledge-sharing and accountability.
• Systematic oversight activities provide valuable lessons for improving laboratory performance and quality.
• Continued focus on information dissemination and training is essential for strengthening GCLP compliance globally.