The DAIDS Clinical Laboratory Oversight Team (DCLOT), made up of DAIDS laboratory staff from the Vaccine, Therapeutic and Prevention Programs at DAIDS, is responsible for lab establishment, oversight and implementation of laboratory policies, evaluation of lab performance, and follow-up on lab-related issues. DCLOT members serve as Point of Contacts (POC) to each of the funded clinical trial Networks. Working closely with the respective DCLOT POC, each Network has a laboratory management and oversight team that also supports Network site laboratories, focusing on protocol-related laboratory issues.
DAIDS and Network Laboratory Contacts
|DCLOT POC||Daniella Livnat firstname.lastname@example.org||Usha Sharma email@example.com||Nina Kunwar Nina.firstname.lastname@example.org||Naana Cleland email@example.com|
|Network Lab Center||ACTG.firstname.lastname@example.orgemail@example.comfirstname.lastname@example.orgemail@example.com|
The Network, together with DCLOT, has the final word on a laboratory’s readiness to participate in a study. Ensuring quality laboratory testing requires laboratories to perform testing in compliance with Good Clinical Laboratory Practices (GCLP) and generate reliable test results. To ensure GCLP compliance, DAIDS has developed guidelines and monitors laboratories’ compliance with GCLP through periodic visits/audits performed by NIAID DAIDS HIV Clinical Research Support Services (CRSS) contractors. Because clinical laboratories operating in the US must adhere to CLIA regulations, which are similar to GCLP and include regular inspections, annual GCLP audits are generally not performed but DAIDS may perform periodic visits or for-cause audits at US clinical labs.
Ensuring reliable laboratory test results is accomplished through the monitoring of results obtained by laboratories on proficiency testing samples. DAIDS employs a few laboratory quality assurance contracts that work closely with DCLOT, the Networks and site laboratories to help ensure the quality of testing:
DAIDS Laboratory Quality Assurance Contracts
|Contract Name||Target Support|
|IQA||The Immunology Quality Assessment contract (IQA), administered by Duke University, provides proficiency testing services for CD4 testing and PBMC cryopreservation. The contract also assists US specimen processing and End- point laboratories resolve GCLP audit observations.|
|VQA||The Virology Quality Assurance contract (VQA), administered by Duke University, provides proficiency testing services for virological testing.|
|SMILE||Patient Safety Monitoring in International Laboratories (SMILE) provides proficiency testing services for all other testing mandated by study protocols (e.g. safety and diagnostic tests) at international laboratories. SMILE also helps laboratories resolve observations resulting from the GCLP assessments at international laboratories.|
The laboratories that will be used for Network studies will be supported by one or more of the above resources. US clinical laboratories must perform proficiency testing according to CLIA regulations; therefore, proficiency testing is not provided by DAIDS for US clinical laboratories.
Related Training Courses on the DLP
|Name||Description and Audience|
|Good Clinical Laboratory Practice (GCLP) – English||
This training describes the standards to be followed by laboratories that process or perform analysis or evaluation of clinical trial samples. Training is required for international clinical laboratory staff involved in specimen processing and testing.
Training is available in English, Spanish, French, Portuguese, and Thai.
|GCLP Training Curriculum Recertification – 2021 (English)||Training for those laboratory staff who have already completed the initial GCLP training and need to recertify. The frequency of this training must be sufficient to ensure that employees remain familiar with the requirements applicable to them – it is up to the discretion of the lab management.|
|Preparation for Regulatory Inspections at Laboratories||This module is intended for staff of laboratories that are participating in DAIDS-supported and/or sponsored clinical trials so that they may prepare themselves and their laboratories for regulatory inspections|
|Inspection Awareness & Preparedness for CRS Inspections||Three modules giving an overview of what regulatory inspections at a CRS involve, what can be expected, and how to prepare. All personnel who would expect to be involved with a site inspection should take this training.|
Please see the below links for additional LDMS resources and training.