Clinical Laboratory Quality Management Systems
The University of Glasgow undertakes a variety of laboratory based clinical research activities, some of which may fall under specific regulations, such as Clinical Trials of Investigational Medicinal Products (CTIMPS).
The University of Glasgow has a clinical laboratory usage policy which you can access here: Policy on clinical laboratory definitions and categorisations
If you intend to store or analyse any sample derived from ANY Clinical Trial of an Investigational Medicinal Product, your laboratory must have a Quality Management System (QMS) in place.
Clinical research laboratories are required to follow the Good Clinical Practice (GCP). GCP is applicable to all laboratories performing analyses which contribute to the (primary, secondary and exploratory) endpoints of a clinical trial. The EMA reflection paper European Medical Agency - Reflection paper for laboratories that perform the analyses or evaluation of clinical trial samples provides a starting point as to the consideration of laboratory standards that are required when conducting CTIMP related laboratory work.
For CTIMPs, where the laboratory analysis is limited to exploratory endpoint analysis only, it is highly recommended that the research team consider during the trial design phase whether the exploratory analyses could be completed as a stand-alone clinical study with its own study protocol and ethical approval. Please contact the Research Regulation and Compliance Office if you are considering alterations to trial design.
If you are involved in Clinical Trials of Investigational Medicinal Products that are co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde you should be aware of, and comply with, the relevant sponsor Standard Operating Procedures which can be found here: https://www.glasgowctu.org/Home/sops/
Please note if you are involved in the storage and/or analysis of ANY samples derived from a Clinical Trial of an Investigational Medicinal Product you should contact the Research Regulation and Compliance Office to discuss your involvement in the study and to ensure the laboratory research is compliant with all relevant UK and expected standards. This includes trials sponsored or co-sponsored by other Universities, NHS Boards & Trusts and Commercial Partners.
All laboratories involved in CTIMP research must have an auditable Quality Management System in place. Laboratories of this type may be subject to external audit by the MHRA as part of the agency’s laboratory inspection programme. The University may also audit laboratories of this nature to ensure appropriate standards are in place.
The University Research Governance Office can provide templates and advice and guidance on the types of Standard Operating Procedures that will be required. These include:
- Laboratory Set-Up and Management
- Laboratory Facilities
- Sample Management
- Laboratory Analysis
- Reportable Issues
In addition, the University Research Regulation and Compliance Office can provide advice and guidance on the types of quality control documents you will require when establishing a laboratory quality management system including:
- Setting up a laboratory master file
- Laboratory roles and duties
- Laboratory competencies
- Laboratory contracts and agreements
- Key contacts
- Housekeeping schedule
- Temperature monitoring
- Refrigerator freezer failure management
- Equipment user acceptance testing
- Equipment maintenance
- Equipment calibration
- Computerised systems and user access levels
- Clinical sample kits
- Consent/withdrawal
- Sample receipt, labelling, tracking and storage
- Processes for damaged, unexpected or mislabelled samples
- Assay validation
- Computerised system validation plans
- Analytical plans
- Review and release of results
- Reportable issues
Once you have established your laboratory Quality Management System the University Laboratory Audit tool will be used by the Research Regulation and Compliance Office to review and approve the laboratory for any involvement in a CTIMP study.
You should not initiate CTIMP related laboratory work without prior agreement from the Research Regulation and Compliance Office.