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PBMC Laboratory Readiness Guide and Resources

​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.

In addition to the comments provided here, laboratory personnel will find it helpful to review the DAIDS Clinical Research Policies and Standard Procedures Documents, especially the DAIDS Good Clinical Laboratory Practices (GCLP) Standards. Online GCLP training is available through the DAIDS Learning Management System.

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