Clinical Trial Laboratory Setup Plan
Setup plan that begins by determining which standard actually governs, because good clinical laboratory practice exists in the gap between nonclinical GLP and the diagnostic standards and neither fits trial sample analysis. Covers a quality system built around the trial rather than the specimen, run acceptance criteria fixed before use, competence evidenced per method, equipment with its failure impact on results, and an end-to-end data path. 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.
Good clinical laboratory practice exists because of a gap. Nonclinical GLP governs safety studies and does not fit trial sample analysis; the diagnostic standards govern testing for the care of an individual patient and do not fit it either. Which standard governs your laboratory is your determination, and setting up under the wrong one produces a well-run laboratory that cannot support the trial.
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) and the EMA reflection paper EMA/INS/GCP/532137/2010 set the expectations for laboratories analysing samples from clinical trials — an activity governed by neither nonclinical GLP nor the diagnostic laboratory standards. Neither document accredits a laboratory, chooses your acceptance criteria, or decides that an existing accreditation is sufficient for trial work; that determination is the laboratory’s and the sponsor’s to make and evidence. The plan structure is SPEQ practitioner synthesis.