The Cross-Network Cold Chain Guidelines describe guidance for utilizing and maintaining optimal cold chain temperature of specimens during retrieval or shipment. These guidelines are meant to supplement the Cross-Network PBMC Processing SOP.
The Cold Chain Guidelines are meant to supplement the Cross-Network Peripheral Blood Mononuclear Cell (PBMC) Processing Standard Operating Procedure (SOP). This document is intended to be used by all HIV/AIDS Clinical Trials Networks of the National Institute of Allergy and Infectious Diseases (NIAID). Network protocol-specific instructions supersede those present in this guidelines document.
This document describes guidelines for utilizing and maintaining optimal cold chain temperature of specimens during the retrieval process within the laboratory or upon shipment to an external laboratory/repository.
Version 1.0 of the Cold Chain Guidelines is effective as of April 26, 2018.
In certain circumstances (e.g., analyzer repair or breakdown, lack of available consumables, lack of required reagents or control material, continued failure in an EQA program), a laboratory may need to use back-up equipment or a back-up laboratory for testing and reporting study specimen results. To ensure the safety of research subjects and the quality of data produced using back-up equipment, the primary testing laboratory must be able to demonstrate acceptable testing proficiency and equivalency between the primary and back-up instruments and/or laboratories for the relevant analyte(s) using tools such as laboratory audit reports, EQA history, instrument validations and reference ranges.
The development and approval of a back-up plan that demonstrates equivalency between back-up instruments and/or laboratories is the responsibility of the director of the primary testing laboratory.
These guidelines are intended to provide information for the directors of DAIDS-sponsored clinical laboratories that perform testing for DAIDS-sponsored clinical trials. They outline the most thorough and ideal approach to developing and approving a back-up plan. However, the director of the primary laboratory may need to deviate from these guidelines depending on the analyte and the testing options available.
The purpose of the “PBMC Laboratory Readiness Guide and Resources” is to help PBMC processing laboratories prepare to meet Good Clinical Laboratory (GCLP) standards and/or for a DAIDS audit. This document is based on a PBMC laboratory audit shell, and helpful guidance was added by experienced members of the ACTG/IMPAACT Laboratory Technologist Committee (LTC).
The PBMC laboratory audit shell does evolve over time, and so this resource might not address every question in the audit shell. However, the differences will be minor. It is recommended that laboratory staff thoroughly review the audit shell sent by the auditor in advance of the visit. This document is intended for ACTG/IMPAACT laboratories but may be useful for other networks.
Please note that the guidance and resources in this document were not developed by DAIDS or PPD.
Use of the Cross-Network PBMC Processing SOP is required for all laboratories cryopreserving PBMC for ACTG, IMPAACT, HPTN, HVTN and MTN.
The TB Sourcebook details essential technical components (Key Elements) of mycobacteriology laboratory procedures for laboratories participating in TB clinical trials sponsored by the ACTG and IMPAACT.
The Mycobacteriology Laboratory Sourcebook for Harmonization and Support of Tuberculosis (TB) Clinical Trials was developed to ensure high quality results and comparability of data across laboratories participating in TB clinical trials sponsored by the AIDS Clinical Trials Group (ACTG) and International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Networks.
The Sourcebook was developed as a reference for all laboratorians participating in TB clinical studies; however, it will also be informative for clinical staff involved in studies and those developing study protocols. Checklists consisting of the Key Elements and other important technical points for each of the laboratory procedures are included to assist the laboratories in performing self-assessments and auditors in assessing procedures for quality elements.
Mycobacteriology Laboratory Sourcebook for Harmonization and Support of Tuberculosis (TB) Clinical Trials v1.0
Version 1.0 of the Mycobacteriology Laboratory Sourcebook is effective as of March 07, 2018.
The purpose of the “Decision Tree to Mitigate Recurring Reagent and Supply Shortages” is to help DAIDS-supported and/or sponsored laboratories mitigate reagent and supply shortages.
This document was prepared by the Division of AIDS Clinical Laboratory Oversight Team (DCLOT) and Cross-Network Laboratory Focus Group (LFG) and represents a consensus from the Laboratory Centers of the HVTN, HPTN, MTN, ACTG, IMPAACT, and DCLOT.