ASSESSMENT OF GCP COMPLIANCE WITHIN THE LABORATORY
Some clinical trials have laboratory-based primary or secondary analytical end-points defined in the
trial protocol. These analyses would be expected to be carried out to Good Clinical Practice
standards in the laboratory so that the data produced are reliable and fully documented.
Your site may be involved in carrying out laboratory-based primary or secondary analytical endpoints for a clinical trial sponsored by the University of Birmingham. This questionnaire is designed
as a self-assessment tool to enable you to assess standards within your facility and identify any
actions required to achieve compliance.
For MHRA guidance as to what standards are required please visit:
http://www.mhra.gov.uk/home/groups/is-insp/documents/websiteresources/con051910.pdf
Please note that the list of requirements identified in the questionnaire will be included in the
contractual agreement between the Sponsor and the laboratory site.
NAME OF CLINICAL TRIAL:
CLINICAL TRIAL SITE:
LABORATORY LOCATION(S):
LABORATORY CONTACT DETAILS:
For questions related to the completion of this self–assessment questionnaire please contact the
Research Support Group at the University of Birmingham
researchgovernance@contacts.bham.ac.uk
1. ANALYTICAL FACILITIES AND LABORATORY AREAS
Compliant
Noncompliant
Are under restricted access.
Are sufficiently clean and orderly to preclude contamination and
mix-ups.
Contain equipment which is adequately tested, calibrated and
maintained, and records of this are kept.
Have secure and controlled areas for the storage of raw data.
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2. PERSONNEL WORKING WITHIN THE FACILITY
Compliant
Noncompliant
Compliant
Noncompliant
Compliant
Noncompliant
Are adequately trained for the function they perform and this
training is documented.
3. QUALITY MANAGEMENT
A document control system is in place to manage the review,
authorisation, distribution, withdrawal and archive of laboratory
documents.
Basic general principles of quality assurance are applied, making use
of a combination of formal training, controls, quality checks and
audit.
Records can be easily identified and are available for review when
required.
Deviations from approved procedures are properly authorised and
documented.
An organogram (or equivalent) exists which identifies the individuals
responsible for the management of studies using the facility.
4. SAMPLE HANDLING AND STORAGE
Samples are properly logged, stored and identified throughout.
Written procedures describing sample receipt, storage and tracking
practices are followed.
Adequate sample storage areas exist which are monitored for
compliance (e.g. temperature).
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5. ANALYTICAL PROCEDURES
Compliant
Noncompliant
Compliant
Noncompliant
If you are developing the analytical method please confirm that an
analytical method validation plan and report can be prepared prior
to the initiation of sample analysis.
If you are developing the analytical method please confirm that an
assay run acceptance SOP will be developed.
Documented, validated and approved analytical methods and
associated SOPs will be used.
Safe and secure storage is available for reagents and solutions to be
used in the analysis.
6. HANDLING ANALYTICAL DATA
Data resulting from analysis can be recorded directly, promptly and
permanently.
All analytical data can be traced back to original records of data and
the procedures and materials used to obtain that data.
Systems are in place for review and verification of data results,
calculations and reports.
If you are developing the analytical method please confirm that data
handling SOPs will be produced and that standard procedures will
be in-place to describe the handling of unexpected or out of range
results and repeat analysis.
Computer software used in the analysis has been adequately tested
to ensure consistently accurate and reliable results.
The facility maintains sufficient backup systems to prevent data loss
in the event of a major system failure.
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