About CPQA’s Assay Peer Review Program
CPQA’s blinded peer review program assures the quality and acceptability of the bioanalytical methods used by a clinical pharmacology laboratories (CPL). A laboratory’s assay validation report (AVR) and subsequent method standard operating procedure (SOP) methods are reviewed according to CPQA’s Guidelines for Chromatographic Method Development and Validation . Using these guidelines assures that methods are reviewed using a consistent set of standards.
The method review process is blinded—reviewers do not know which laboratory’s documents they are reviewing and laboratories do not know the names of reviewers. The process of blinded, peer review provides laboratories with objective, unbiased feedback of laboratory-developed tests. Reviewers are hand-selected by CPQA based on their knowledge, expertise, and experience in pharmacology assay method development.
The method peer review program has performed reviews from laboratories across the world. The peer review program was implemented using a custom-built web application specifically designed for method reviews. Method submission and review are handled through the secure application, which allows CPLs to submit method documents and follow the submission throughout the review process. Reviewers also use the web application to complete reviews and provide the CPLs with comments and a score.
For more information about the review process refer to AVR/SOP Guidance (Analytical Validation Report/Standard Operating Procedure Guidance)
Peer Review Process
Process for AVR/SOP submission and review is easy
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Submit
- CPL submits through web-based CPQA AVR SOP Submission Utility
- CPL receives email verification of submission
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Assign
- CPQA receives email notification and assigns to reviewer using the online utility
- Reviewers are blinded
- Reviewer confirms assignment using the online utility
- CPL receives email notification that submission is in review
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Score
Reviewer completes review using online utility, and assigns one of the following scores: accept or revise.
CPL receives email notification that the review has been completed.
Accept: The method accepted and no revisions needed
OR
Revise: The method tentatively accepted but requires minor revisions or the method has not been accepted and requires major revision. In both cases, the CPL will need to re-submit the method with the revisions
Approved AVRs are reviewed by CPQA leadership. Approved methods are also posted in the CPQA Drug Assay Directory.
Drug Assay Directory
CPQA compiles details for samples, analysis, and performance of all CPQA-approved methods in the Drug Assay Directory, which can be used by network leadership, protocol teams, committees, and support staff to determine what drug testing and methods are available at participating laboratories.
