Sample Chain of Custody Record
Custody record accounting for every sample from the participant to the result and its disposal. Unique identifiers never reused, every transfer recorded with person, time and condition, transit excursions assessed against analyte stability, receipt reconciled against expected, aliquots inheriting the parent chain, and a documented end state for each sample. 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.
Chain of custody records that a sample analysed in the laboratory is the sample taken from a specific participant at a specific visit, and that its condition never left the range the assay requires. It is unusual among trial controls in that it can only be built forwards: a gap found later cannot be filled, because the missing evidence is the record nobody made at the time.
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 expectations for sample identification, handling, storage and traceability, and the EMA reflection paper EMA/INS/GCP/532137/2010 addresses inspection of trial-related laboratory activity and the records supporting it. Neither defines your identifier scheme, your acceptable transit conditions, or the stability data an excursion is judged against — those follow from your assay and belong to the sponsor and laboratory. The record structure is SPEQ practitioner synthesis, and renders as a spreadsheet because custody is a register.