Procedures for GCP compliance in the laboratory
UoB QMS reference number: UoB-CLN-LAB-SOP-001
Purpose:
The analysis or evaluation of samples collected from subjects participating in clinical trials forms a key
part of the clinical trials process. The purpose of this SOP is to describe procedures which will ensure
that sample analyses or evaluations which drive clinical care (e.g. safety and eligibility screening), or
which monitor the efficacy of Investigational Medicinal Products and therefore impact on the
evaluation of trial outcomes, are performed to an acceptable standard which will ensure that patient
safety is not compromised, that data is reliable and accurately reported, and in accordance with
accepted principles of GCP, with applicable law, and with established policies of the University of
Birmingham.
Scope:
This SOP applies to all laboratories within the University of Birmingham that undertake clinical trial
sample analyses or evaluations which drive clinical care (e.g. safety and eligibility screening), or
which monitor the efficacy of Investigational Medicinal Products and therefore impact on the
evaluation of trial outcomes.
Implementation plan:
This template will be implemented directly after the implementation date.
Date of implementation:
01-Mar-2016
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Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
Print Date:
12-Mar-16
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Procedures for GCP compliance in the laboratory
Responsibilities:
Individual clinical trials must identify named individual(s) who assume responsibility for conducting the
scientific analyses, for reporting the results of the analysis or evaluation, for assessing risks to sample
and data integrity following adverse events, for reporting any deviations from written procedures or
the clinical protocol and for reporting serious breaches in GCP.
They must also identify the personnel responsible for laboratory and equipment management and for
monitoring GCP compliance.
Responsibilities and reporting lines will be established and documented prior to the initiation of
analytical work, for example, by the production of an organogram.
Procedure:
Develop and implement written procedures and the appropriate documents for record keeping (see
below). Consider using the QCDs developed as part of the UoB Laboratory QMS in order to produce
these. The QCDs include checklists, guidelines, templates, and example proforma. They are listed at
the end of this SOP. The GCP in the laboratory checklist (see UoB-CLN-LAB-QCD-001) lists the
relevant tools against specific tasks.
Consider developing a version-controlled Laboratory Manual which contains the overall analytical plan
and all trial-specific procedures pertaining to the analytical process (see UoB-CLN-LAB-QCD-014
Laboratory Manual).
Prior to the start of clinical trial sample analysis
 Define and document the roles and responsibilities of the named individuals involved (see
‘Responsibilities’ section above). Ensure that reporting lines are clear.
 Properly validate analytical assays with defined acceptance criteria. Document the assay
validation process.
 Ensure that laboratory staff are appropriately trained on procedures, on relevant policies and
SOPs, on current relevant MHRA guidelines, and on GCP. Record training and competencies.
 Ensure that the appropriate laboratory risk assessments are in place.
Throughout clinical trial sample analysis
 Ensure there is a mechanism in place to ensure that the laboratory is informed in a timely
manner if consent is withdrawn so that no further data is generated or collected.
 Ensure that a copy of the trial protocol, or as a minimum, the sections of the clinical protocol
which are relevant to the activities undertaken in the laboratory (and amendments relevant to
the laboratory analyses), is always available to laboratory staff.
 Ensure that current versions of the trial-specific written procedures and associated
documentation (e.g. proforma) relevant to the analytical procedures are readily available to
laboratory staff.
 Restrict access to the laboratory, or laboratory area, to appropriate personnel as far as
possible.
 Maintain and document laboratory housekeeping regimes.
 Ensure that all equipment is monitored, maintained and calibrated. Ensure that records of this
are maintained and stored safely and securely. These records should be archived
appropriately at the end of the clinical trial.
 Ensure that equipment which is shared with other researchers analysing non-clinical trial
samples is maintained to a standard that will not compromise the integrity of clinical trial data.
 Store and manage key reagents, controls and standards involved in the analysis according to
trial-specific procedures.
 If it is necessary to use batches (or lots) of key reagents, controls and standards different to
those used during the initial validation, consider re-validation of the assay and document this
as an amendment to the original validation report.
 Maintain accurate records associated with sampling kits sent to sites for the purposes of
sample collection to enable traceability of all components.
Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
Print Date:
12-Mar-16
Page:
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Procedures for GCP compliance in the laboratory
 Ensure clinical trial samples received into the laboratory are processed, stored and analysed
according to trial-specific procedures and remain traceable throughout their life cycle.
 Ensure that records are kept which evidence that samples have been processed, stored and
analysed according to the trial-specific procedures.
 Maintain raw analytical data produced safely and securely, either electronic or hard copy.
 Review and report analytical results according to trial-specific procedures.
 Ensure that the circumstances under which an analysis may be repeated for a particular
sample, for example if an out of range or aberrant result is obtained, are clearly defined and
implemented.
 Ensure electronic data is stored securely and backed up.
 Carry out internal audits/quality checks as and when appropriate. Document the results and
any corrective and preventative actions (which may require updating written procedures).
Laboratory adverse events
 Ensure that laboratory adverse events are dealt with and reported in a timely manner
according to trial-specific procedures.
 Always assess the risk of the adverse event on patient safety, sample and data integrity and
document this.
 Document and implement any corrective and preventative actions (which may require
updating written procedures).
Related documents:
 University of Birmingham Good Clinical Practice in the Laboratory Quality Manual
 UoB-CLN-LAB-QCD-001 GCP compliance in the laboratory checklist
 UoB-CLN-LAB-QCD-002 Equipment maintenance and calibration checks
 UoB-CLN-LAB-QCD-003 Temperature monitoring
 UoB-CLN-LAB-QCD-004 Laboratory access
 UoB-CLN-LAB-QCD-005 Laboratory housekeeping
 UoB-CLN-LAB-QCD-006 Management of shared equipment
 UoB-CLN-LAB-QCD-007 Receipt and traceability of trial participant samples
 UoB-CLN-LAB-QCD-008 Analytical assay validation
 UoB-CLN-LAB-QCD-009 Analytical assay failure
 UoB-CLN-LAB-QCD-010 Impact assessment of equipment failure or equipment calibration failure
 UoB-CLN-LAB-QCD-011 Handling and maintaining raw data
 UoB-CLN-LAB-QCD-012 Receipt, labelling and storage of reagents
 UoB-CLN-LAB-QCD-013 Management and storage of analytical standards
 UoB-CLN-LAB-QCD-014 Laboratory Manual
 UoB-CLN-LAB-QCD-015 Review and release of results
 UoB-CLN-LAB-QCD-016 Adverse events in the analytical laboratory
 UoB-CLN-LAB-QCD-017 Laboratory audit and quality checks
 UoB-CLN-LAB-QCD-018 Repeat analysis
 UoB-CLN-LAB-QCD-019 Procedures following failure of storage unit
Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
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12-Mar-16
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Procedures for GCP compliance in the laboratory
 UoB-CLN-LAB-QCD-020 Laboratory training record
 UoB-CLN-LAB-QCD-021 Equipment maintenance record
 UoB-CLN-LAB-QCD-022 Single channel pipette calibration check record
 UoB-CLN-LAB-QCD-023 Multi channel pipette calibration check record
 UoB-CLN-LAB-QCD-024 Thermometer and temperature probe calibration check record
 UoB-CLN-LAB-QCD-025 Balance calibration check record
 UoB-CLN-LAB-QCD-026 Housekeeping record
 UoB-CLN-LAB-QCD-027 Training record for shared equipment
 UoB-CLN-LAB-QCD-028 Analytical failure report
 UoB-CLN-LAB-QCD-029 Impact assessment of equipment failure or equipment calibration failure
report
 UoB-CLN-LAB-QCD-030 Reagent receipt and storage record
 UoB-CLN-LAB-QCD-031 Temperature monitoring record
 UoB-CLN-LAB-QCD-032 Adverse event report
 UoB-CLN-LAB-QCD-033 Analytical assay validation plan
 UoB-CLN-LAB-QCD-034 Analytical assay validation report
 UoB-CLN-LAB-QCD-035 Analytical plan
 UoB-CLN-LAB-QCD-036 Self-assessment of GCP compliance in the laboratory
 UoB-CLN-LAB-QCD-037 Samples collected during clinical trial
 UoB-CLN-LAB-QCD-038 Laboratory Good Clinical Practice
 UoB-CLN-LAB-QCD-039 Blood processing record
 UoB-CLN-LAB-QCD-040 Record of sampling kit
References:
 European Medicines Agency (EMA): Reflection paper for laboratories that perform the
analysis or evaluation of clinical trial samples Guidance on the maintenance of regulatory
compliance in laboratories that perform the analysis or evaluation of clinical trial samples
(2012):
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideli
ne/2012/05/WC500127124.pdf
 Good Clinical Laboratory Practice. A quality system for laboratories that undertake the
analyses of samples from clinical trials v2 2012. BARQA:
http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Dow
nloads/Good_Clinical_Laboratory_Practice_GCLP.pdf
Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
Print Date:
12-Mar-16
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Procedures for GCP compliance in the laboratory
Abbreviations and Definitions:
Term
Description
GCP
Good Clinical Practice guidelines
Laboratory
A facility that conducts manipulation, analysis or evaluation of samples
collected as part of a clinical trial; such analysis or evaluation may include the
generation of pharmacokinetic or pharmacodynamic data, safety data, primary
efficacy data, histopathology data or data used to support any other stated
primary or secondary end point.
Laboratory
adverse events
A laboratory adverse event refers to any event which may compromise patient
safety, sample or data integrity. Examples include security breaches,
equipment failure or calibration failure, analytical failures, or the production of
aberrant or out of range results.
Policies
Policies are developed to describe the approach of the UoB on areas that
heavily regulated. Policies may also be developed when there is ambiguity in
how regulatory requirements should be implemented in the QMS or when
procedures to be captured in the QMS address areas controversial within the
UoB at the time of implementation. Policies explain why the UoB has its
procedures, especially when they seem to deviate from the regulatory
requirements. Policies should be read in conjunction with the relevant SOP.
Policies that are not part of a Quality Manual are coded up as ‘POL’.
QCD
See “Quality Control Documents”
QMS
Quality Management System
Quality Control
Documents
Quality Control Documents can be instructions, forms, templates or checklists.
They are developed to share best practices, promote standardisation to
guarantee quality standards are maintained and reduce resources otherwise
needed to develop similar documents. Unless indicated otherwise in the
relevant SOP, QCDs are not mandatory and are designed to be an optional aid
to UoB staff.
Quality
Management
System
A Quality Management System (QMS) is a system that includes procedures
and policies to describe how certain tasks should be performed and that
encapsulate any standards and/or regulatory requirements that may apply to
those tasks. By adhering to the Quality Management System, the user and the
UoB will be assured that applicable regulations are adhered to.
SOP
See “Standard Operating Procedures”
Standard
Operating
Procedures
Standard Operating Procedures are detailed written instructions to achieve
uniformity in the performance of a specific function. They define tasks, allocate
responsibilities, detail processes, indicate documents and templates to be used
and cross-reference to other work instructions and guidance or policy
documents. They are standards to which the UoB may be audited or inspected.
UoB
University of Birmingham
See Glossary of Terms
Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
Print Date:
12-Mar-16
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Procedures for GCP compliance in the laboratory
Development summary:
Author:
Name:
Jane Steele
Function:
Director, Advanced Therapies Facility
Date:
See original copy
Reviewed by:
Clinical Trials Oversight Committee
Signature:
See original copy
Signature:
See original copy
Signature:
See original copy
Authorised by:
Name:
Wilma van Riel
Function:
Head of Clinical Research Compliance
Date:
See original copy
Name:
Professor Julian Bion
Function:
Chair of the Clinical Trials Oversight
Committee
Date:
See original copy
Issue date:
Supersedes:
Procedures for GCP compliance in the laboratory v1.0 (EAv1.0)
Reason for update:
Findings and recommendations following MHRA inspection 23rd – 25th June 2015; clarification
included regarding record keeping in relation to samples and assays.
Review of final version:
Date:
Reviewed by:
Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
Signature:
Outcome:
Print Date:
12-Mar-16
Page:
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Procedures for GCP compliance in the laboratory
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Document code:
UoB-CLN-LAB-SOP-001
Version no:
2.0
Print Date:
12-Mar-16
Page:
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