SOPREFERENCE OUTLINE

Clinical Trial Laboratory Manual

The site-facing manual that acts at the moment the sample is taken, where most trial sample problems are created and become irreversible. Specifies tube, additive and order of draw per assessment, processing steps with permitted time windows, labelling that keeps blinding intact and survives storage temperature, storage and shipping with excursion handling, and an explicit statement of what is time-critical. Maps to WHO GCLP (2009).

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.

CHECKING ACCESS

Checking your Professional access…

REGULATIONS MAPPED
WHO GCLP (2009)
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

The manual stands between a protocol and dozens of sites collecting samples in ways nobody anticipated. Most sample problems are created before the laboratory ever sees the tube, and they are irreversible — this is the only control that acts at the moment the sample is taken. What is genuinely time-critical, and what merely looks urgent, is the sponsor’s determination and must be stated rather than implied.

What's Inside

✓Version control with site distribution, receipt confirmation and withdrawal of superseded copies
✓Tube, additive, volume, order of draw and inversions specified per assessment rather than per visit
✓Processing steps with a permitted time window measured from collection, not from arrival at the laboratory
✓Labelling that preserves blinding and survives the storage temperature, including deep frozen conditions
✓Storage and shipping conditions, with what a site does when a shipment cannot leave as planned
✓An explicit statement of what is time-critical and what is not, so sites triage correctly under pressure
✓Query and contact routes, so a site with a question does not improvise at the chair

How to Use It

1Write collection instructions per assessment rather than per visit, because a site draws for assessments and reads the manual at the chair.
2Never omit the order of draw — additive carryover produces results that are plausible and wrong, so nobody thinks to question them.
3Give every processing step a time window measured from collection, or the step is left to whatever the clinic schedule allows.
4Qualify label stock and ink for the storage temperature, including deep frozen; ink that fails turns an identified sample anonymous.
5State plainly which steps are time-critical, so a site under pressure sacrifices the right thing rather than the load-bearing one.
6Confirm receipt and withdrawal of superseded versions at every site after any sampling change, or two manuals run in parallel.
DOCUMENT CONTENTS

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.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and Version Control
2Collection — Tube, Additive and Order of Draw
3Processing — With Time Windows
4Labelling and Blinding
5Storage and Shipping
6What Is Time-Critical
REGULATORY CONTEXT

WHO Good Clinical Laboratory Practice (2009) sets the expectations for the collection, handling, processing, storage and transport of clinical trial samples, and for the documented instructions under which site staff perform them. It does not specify your tubes, your time windows, your label stock, or which steps in your assay chain are genuinely time-critical — those follow from the assay and are the sponsor’s and laboratory’s determination to make and justify. The manual structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
WHO GCLP (2009)
Browse the standards catalog →