Laboratory Manual
Guideline
Purpose and use of this guideline document
The purpose of this document is to provide guidelines for the set up, maintenance and distribution of a
laboratory manual. The laboratory manual, or relevant sections of it, can be distributed to investigator
sites, in order to achieve consistency in sample collection, handling and analysis.
The laboratory manual should be readily accessible to all members of staff who require it during the
trial, and should be archived with the rest of the trial documentation when the trial closes.
Guidelines
Distribution of laboratory manuals
 Set up laboratory manuals for each site where appropriate.
 Include the procedures that are relevant to the activities at that site i.e. some clinical sites may
only require procedures associated with sample collection, processing and transport, whereas
laboratories will require written assay procedures.
 Ensure all staff using the laboratory manual at all sites are trained.
Version control
 Take the necessary steps to ensure that only the current version of any written procedure
contained within the laboratory manual is being followed.
o If new versions are generated, ensure these are distributed to each site
o Instruct sites to confirm receipt of the new version (e.g. by e-mail)
o Instruct sites to confirm that any copies of the superseded version have been destroyed
(e.g. by e-mail)
 Organise further training if appropriate.
Layout (include sections below where relevant to the site using the manual)
 Front cover page providing the following details:
o Name of trial.
o Name and address of the Chief/Principal Investigator.
o Name and address of the trial Sponsor.
 Analytical plan.
o Consider including a document depicting the overall analytical plan at the front of the
laboratory manual (a template is available see UoB-CLN-LAB-QCD-035 Analytical plan).
 Scope.
o Detail the sites to which the laboratory manual (or appropriate sections) will be sent and
used.
o It is possible that some sites will receive the whole manual whereas others will only
receive the sections relevant to their activities e.g. sample collection, processing and
transport at clinical sites, or analytical procedures at laboratories carrying out sample
analysis or evaluation
 Consumables
o Consider including a list of all consumables e.g. syringes, tubes, blood containers,
preservatives, fixatives, transport medium etc. involved with sample collection, receipt,
processing, transport, storage and analysis. Include the source and catalogue number.
o If this is not included as a section here, then ensure that this is included with individual
written procedures
 Written procedures.
o Laboratory and equipment maintenance.
o Sample collection and transfer.
o Sample receipt and traceability.
o Receipt, labelling and storage of reagents.
UoB-CLN-LAB-QCD-014 Laboratory Manual v1.0 (EAv0.1)
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Laboratory Manual
Guideline
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Management and storage of analytical standards.
Sample analysis.
Handling and maintaining raw data.
Review and release of results.
Repeat analysis.
Adverse events (equipment failure or calibration failure, failure of a storage unit,
analytical assay failure).
 Contact details
Related documents
 UoB-CLN-LAB-SOP-001 Procedures for GCP compliance in the laboratory
 UoB-CLN-LAB-QCD-035 Analytical plan
UoB-CLN-LAB-QCD-014 Laboratory Manual v1.0 (EAv0.1)
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