GCP compliance in the laboratory
Checklist
Introduction
Samples collected from clinical trial participants that undergo analyses or evaluations which drive
clinical care (e.g. safety and eligibility screening), or which monitor the efficacy of Investigational
Medicinal Products (IMPs) and therefore impact on the evaluation of trial outcomes, are required to be
conducted to Good Clinical Practice (GCP) in the Laboratory standards. This is to ensure that sample
analysis is performed to an acceptable standard so that patient safety is not compromised and that
data produced is reliable and accurately reported. The MHRA has responsibility for monitoring
laboratories that perform these types of analytical assays and will carry out inspections.
You may be involved in developing analytical assays or evaluations using clinical trial samples which
are required to be performed to GCP standards, and which will be carried out within a laboratory at
the University of Birmingham. Below is a checklist of procedures which, if implemented, will enable
you to conduct sample analyses or evaluations in a manner which is compliant with GCP regulations.
How to use this checklist
You are advised to consider the implementation of the procedures listed. The relevant Quality Control
Document (QCD) which can help with the development of written procedures and associated
proforma are referenced.
It is recommended that a trial-specific Laboratory Manual is produced which contains the overall
analytical plan and associated written procedures. Templates for the analytical plan and the
Laboratory Manual are available (see UoB-CLN-LAB-QCD-035 Analytical Plan and UoB-CLN-LABQCD-014 Laboratory manual).
Checklist
PROCEDURE
ADVICE/COMMENTS
RELEVANT QCD
ORGANISATION
Define and document the roles and
responsibilities of the named
individuals involved and reporting
lines, including back up
arrangements
Produce an organogram
Ensure the trial protocol (or relevant
sections) is readily accessible to
laboratory staff
Keep a copy in the laboratory
Ensure current versions of written
procedures are readily accessible to
laboratory staff
Keep hard copies in the
laboratory within a Laboratory
Manual or easily accessible
electronically; ensure superseded
documents are stored separately
for reference and are archived
with all other trial documents
Ensure mechanisms are in place to
ensure that the laboratory is informed
if consent is withdrawn to ensure that
no further data is generated or
collected
Written procedure recommended
to indicate lines of communication
Restrict access to the laboratory, or
laboratory area, to appropriate
personnel
UoB-CLN-LAB-QCD-001 GCP Compliance in the laboratory checklist v1.0 (EAv1.0)
UoB-CLN-LABQCD-014
UoB-CLN-LABQCD-004
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GCP compliance in the laboratory
Checklist
UoB-CLN-LABQCD-005
v Maintain and document laboratory
housekeeping regimes
UoB-CLN-LABQCD-026
Ensure the risk assessments
associated with laboratory procedure
are in place
Carry out regular internal audits or
quality checks
UoB-CLN-LABQCD-017
STAFF
Ensure laboratory staff have a signed
and dated copy of their job
description which clearly defined their
roles and responsibilities with respect
to the analysis
Ensure laboratory staff have received
appropriate GCP training
Set up training records
UoB-CLN-LABQCD-020
Ensure laboratory staff have been
adequately trained to undertake their
respective tasks and records of
training and competency are set up
and available for inspection
Set up training records; these
need to be readily available and
archived with all other trial
documents
UoB-CLN-LABQCD-020
EQUIPMENT
UoB-CLN-LABQCD-002
UoB-CLN-LABQCD-003
Ensure ALL equipment which used
during the analyses is maintained,
regularly serviced and calibrated
Written instructions should be
produced to enable this and
records must be kept and
available for inspection; service
records may be held centrally by
senior technical staff but ensure
that they could be found at
inspection
UoB-CLN-LABQCD-021
UoB-CLN-LABQCD-022
UoB-CLN-LABQCD-023
UoB-CLN-LABQCD-024
UoB-CLN-LABQCD-025
UoB-CLN-LABQCD-031
Ensure equipment which is shared
with other researchers analysing nonclinical trial samples is maintained to
a standard that will not compromise
the integrity of clinical trial samples
Written procedure recommended
UoB-CLN-LAB-QCD-001 GCP Compliance in the laboratory checklist v1.0 (EAv1.0)
UoB-CLN-LABQCD-006
UoB-CLN-LABQCD-027
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GCP compliance in the laboratory
Checklist
Ensure storage units housing
samples and key reagents, controls
and standards are separate and
secure, preferably under restricted
access
Ensure computer systems are
validated and documentation
demonstrating this is available
ASSAY VALIDATION
Properly validate analytical assay
with defined acceptance criteria prior
to the start of clinical trial sample
analysis and document this process
Produce an assay validation plan
and report and consider getting
these documents reviewed and
signed off by an appropriate
person
UoB-CLN-LABQCD-008
UoB-CLN-LABQCD-033
UoB-CLN-LABQCD-034
CONDUCT DURING SAMPLE ANALYSIS
Ensure samples are assessed upon
receipt into the laboratory and that
action will be taken if integrity or
viability has been compromised, or if
samples are missing, unexpected or
mislabelled
Ensure receipt of all samples is
properly logged, that appropriate
anonymisation processes are in
place, that they are processed, stored
and analysed according to the trial
protocol and that all samples remain
traceable throughout their life cycle
Ensure analytical procedures are
followed by trained staff
Written procedures should be
produced
UoB-CLN-LABQCD-007
Written procedures should be
produced
Precise written instructions
should be available and it is
recommended that these are
contained within the Laboratory
Manual
UoB-CLN-LABQCD-012
Ensure key reagents, controls and
standards used during sample
analysis are stored and managed
appropriately
Written procedure recommended
Ensure raw analytical data produced
(either electronic or hard copy) is
stored safely and securely
Written procedure recommended
UoB-CLN-LABQCD-013
UoB-CLN-LABQCD-030
UoB-CLN-LAB-QCD-001 GCP Compliance in the laboratory checklist v1.0 (EAv1.0)
UoB-CLN-LABQCD-011
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GCP compliance in the laboratory
Checklist
Ensure analytical data produced can
be traced back to original raw data
and the procedures and materials
used
Develop worksheets to record the
relevant information for each
analytical run
Ensure analytical results are reported
accurately
Written procedures should be
produced which include
instructions for data handling and
all necessary steps to ensure
accuracy, for example crosschecking, review, validation of
any data manipulations
UoB-CLN-LABQCD-015
Ensure electronic data is stored
securely and backed up
ADVERSE EVENTS
UoB-CLN-LABQCD-009
Ensure procedures are in place in the
event of laboratory adverse events
such as security breaches,
equipment failure or calibration
failure, analytical failure, breaches in
GCP, deviations from the trial
protocol or written procedures
Written procedures should be
produced which enable adverse
events to be dealt with and
recorded in a timely manner and
which define reporting lines
clearly
UoB-CLN-LABQCD-016
UoB-CLN-LABQCD-019
UoB-CLN-LABQCD-028
UoB-CLN-LABQCD-032
UoB-CLN-LABQCD-009
Ensure that the risk or impact to
patient safety or sample and data
integrity is assessed following
adverse events and that corrective
and preventative measures are
implemented
UoB-CLN-LABQCD-010
Records should be kept and
available for inspection
UoB-CLN-LABQCD-028
UoB-CLN-LABQCD-029
UoB-CLN-LABQCD-032
Ensure circumstances for the repeat
analysis of samples where, for
example, out of range or aberrant
results are obtained are clearly
defined and implemented
Written procedures should be
produced
UoB-CLN-LAB-QCD-001 GCP Compliance in the laboratory checklist v1.0 (EAv1.0)
UoB-CLN-LABQCD-018
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