QMS - eight new SOPs
Updates to the Standard Operating Procedures (SOPs) for Clinical Research
This Standard operating procedure (SOP) describes the product management processes for the use of medicinal products in clinical research, including Clinical Trials of Investigational Medicinal Products (CTIMP) and Advanced Therapy Investigational Medicinal Products (ATIMPs).
- Type: SOP (applicable to clinical trials and advanced therapy only)
- QMS code: UoB-MED-SOP-001
- Version: 1.0
- Effective date: 14-Mar-2022
This SOP describes the procedures involved in the set-up, initiation and closure of investigator sites. Note: for laboratories, please refer to UoB-CRL-SOP-001 Laboratory Set Up and Management.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-SMA-SOP-001
- Version: 1.0
- Effective date: 14-Mar-2022
This SOP describes the processes involved in setting up and managing a Good Clinical Practice (GCP) compliant laboratory.
- Type: SOP (applicable to clinical studies and non-CTIMP trials)
- QMS code: UoB-CRL-SOP-001
- Version: 3.0
- Effective date: 14-Mar-2022
The purpose of this SOP is to describe procedures which will ensure that equipment within laboratories (and the laboratories themselves) are maintained sufficiently to meet the appropriate standards to allow the handling, processing, receipt, storage or analysis of samples of human tissue for clinical studies or the analysis of human biomaterials which contribute to the (primary, secondary and/or exploratory) endpoints of clinical trials.
- Type: SOP (applicable to samples of human biomaterials which contribute to the (primary, secondary and/or exploratory) endpoints of Clinical Trials of Investigational Medicinal Products (CTIMPs) or of human tissue for clinical studies and non-CTIMP trials)
- QMS code: UoB-CRL-SOP-002
- Version: 3.0
- Effective date: 14-Mar-2022
The purpose of this SOP is to describe procedures which will ensure that human biomaterial management within laboratories (either for clinical trials or for clinical studies) is set up and managed correctly to meet the appropriate standard ensuring that patient safety is not compromised, that data is reliable and accurately reported, and in accordance with applicable law, and with established policies at UoB.
- Type: SOP (applicable to clinical studies and all clinical trials using human tissue)
- QMS code: UoB-CRL-SOP-003
- Version: 3.0
- Effective date: 14-Mar-2022
The purpose of this SOP is to describe procedures which will ensure that the analysis or evaluation of clinical trial samples are performed to Good Clinical Practice (GCP) in the laboratory standard ensuring that patient safety is not compromised, that data is reliable and accurately reported, and in accordance with applicable law, and with established policies at UoB.
- Type: SOP (applicable to all UoB staff involved in the analysis of human biomaterials for clinical trials of investigational medicinal products (CTIMPs) whether these are sponsored by the UoB or sponsored/co-sponsored by another institution)
- QMS code: UoB-CRL-SOP-004
- Version: 3.0
- Effective date: 14-Mar-2022
The purpose of this SOP is to describe the process for ensuring any issues that may impact on participant safety are reported without delay. These may include, but are not limited to, the reporting of unexpected or out of range results and significant deviations from the protocol or analytical plan.
- Type: SOP (applicable to all University of Birmingham (UoB) staff and laboratories performing analyses that contribute to the (primary, secondary and/or exploratory) endpoints of clinical trials of investigational medicinal products (CTIMPs) whether these are sponsored by the UoB or sponsored/co-sponsored by another institution)
- QMS code: UoB-CRL-SOP-005
- Version: 1.0
- Effective date: 14-Mar-2022
The SOP is applicable to all clinical trials of investigational medicinal products (CTIMPs) where the University of Birmingham (UoB) is the sponsor or takes on responsibility for assessing whether an external laboratory that will perform analysis of human biomaterial samples is set-up in compliance with Good Clinical Practice (GCP) laboratory standard. Where clinical research is (co-)sponsored by another institution, this procedure should be followed as far as possible, and in line with the contractual agreement between the UoB and the other institution.
- Type: SOP (applicable to clinical trials only)
- QMS code: UoB-CRL-SOP-006
- Version: 1.0
- Effective date: 14-Mar-2022
See the Quality Management System (QMS) for further details and to access the full UoB QMS for Clinical Research.