Central Laboratory Qualification Record
Qualification record assessing a central laboratory against the trial you are running rather than its brochure: the specific assays and matrices in scope, accreditation verified against the schedule rather than the certificate, empirical cross-site comparability, logistics tested with real shipments before the trial, data transfer and reconciliation agreed in writing, and escalation with an audit before commitment. Maps to WHO GCLP (2009) and EMA/INS/GCP/532137/2010.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A central laboratory promises comparability across every region a trial runs in. Qualification establishes whether that promise holds for your assays, your matrices and your logistics — sponsors who qualify the organisation rather than the specific service discover the gap when one region behaves differently. Whether the comparability data is adequate for your endpoints is the sponsor’s determination, and it cannot be delegated to the laboratory.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
WHO Good Clinical Laboratory Practice (2009) sets the quality expectations for laboratories generating data in clinical trials, and the EMA reflection paper EMA/INS/GCP/532137/2010 addresses sponsor oversight of laboratories used in trials, including contracted ones. Neither qualifies a laboratory for you, defines adequate comparability for your endpoints, or decides which regional facilities you may use. Those determinations stay with the sponsor, who remains accountable for the data. The qualification structure here is SPEQ practitioner synthesis, not an accreditation or an endorsement.