Last updated on 12 November 2024
The University is one of the leading centres for clinical research in the UK. It is committed to supporting clinical research, and it aims for clinical research to be conducted to a high quality standard. For this purpose it has set up a QMS to reflect any applicable regulations, standards and University policies.
All research at the UoB must adhere to the UoB Code of Practice for Research (PDF - 479 KB).
By adhering to the QMS any staff member working in clinical research and the UoB as an institution can be assured that the rights and wellbeing of the individuals participating in clinical research are protected and the data collected is credible. Also, that the clinical research is conducted in compliance with the approved protocol/amendment(s), the applicable regulatory requirements, standards and University policies for designing, conducting, recording and reporting clinical research that involve the participation of human subjects.
The QMS consists of Quality Manuals, Policies, Standard Operating Procedures (SOPs) and associated Quality Controlled Documents (QCDs). The SOPs provide detailed written instructions that must be followed to ensure compliance with the application regulations and standards. While, QCDs can consist of template documents, checklists or guidelines that can be used as a tool to help you follow the SOPs. The use of QCDs may be optional or mandatory; this will be detailed below and in the QCD and/or the related SOP. See also the Glossary of Terms for more information.
For information on selecting the most appropriate public registry for your research, please see the UoB position paper on clinical research registration (PDF - 218 KB).
* Please note that some of our documents are currently under review and links to these documents have temporarily been removed. If you wish to access them please contact us at crct@contacts.bham.ac.uk. If required, you can also access previous versions of documents by contacting us.
Governance Infrastructure
Clinical Research Quality Manual
The purpose of this quality manual is to explain the University of Birmingham’s (UoB) framework for conducting clinical research.
- Type: Quality Manual (applicable to clinical studies and clinical trials)
- QMS code: UoB-CQM-POL-001
- Version: 2.0
- Effective date: 20-Jan-2023
UoB Principles of GCP for Clinical Research
This policy describes the set of University of Birmingham (UoB) principles of Good Clinical Practice (GCP) for the designing, conducting, recording and reporting of research that involves human participants.
- Type: Policy (applicable to clinical studies and clinical trials)
- QMS code: UoB-GCP-POL-001
- Version: 2.0 (EAv1.0)
- Effective date: 02-Mar-2020
UoB Clinical Research Definitions
This policy outlines the UoB definitions for clinical research, differentiating between a clinical trial (CTIMP versus non-CTIMP) and a clinical study. You will also find the MHRA's algorithm to help you determine whether your clinical research projects is a CTIMP, non-CTIMP or clinical study.
- Type: Policy (applicable to clinical studies and clinical trials)
- QMS code: UoB-DEF-POL-001
- Version: 1.0
- Effective date: 21-Aug-2023
Sponsor Oversight for Clinical Research
The procedures for granting initial Sponsor approval for and retaining Sponsor oversight of clinical research within the UoB.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-SPO-SOP-001
- Version: 1.0
- Effective date: 10-Oct-2022
- Type: QCD (optional template, but content is mandatory for clinical trials managed through a UoB CTU)
- QMS code: UoB-SPO-QCD-001
- Version: 1.0
- Effective date: 22-Aug-2022
- Type: QCD (optional tool)
- QMS code: UoB-SPO-QCD-002
- Version: 1.0
- Effective date: 27-Jan-2023
QMS Development and Management
The SOP describes describes why and how a quality management system (QMS) is developed for clinical research at the UoB. This SOP also includes how a QMS is managed, the role of stakeholders, and how documents are prepared, reviewed, authorised and implemented.
- Type: SOP (applicable to all QMSs that relate to clinical research)
- QMS code: UoB-QMS-SOP-001
- Version: 2.0 (EAv1.0)
- Effective date: 20-Jan-2023
This SOP describes how staff training should be performed and documented, with associated QCDs to help evidence staff training.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-TRN-SOP-001
- Version: 2.0
- Effective date: 08-Jan-2024
- Type: QCD (optional template)
- QMS code: UoB-TRN-QCD-001
- Version: 1.0 (EAv2.0)
- Effective date: 24-Nov-2021
- Type: QCD (optional template)
- QMS code: UoB-TRN-QCD-002
- Version: 1.0 (EAv1.0)
- Effective date: 24-Nov-2021
- Type: QCD (optional template)
- QMS code: UoB-TRN-QCD-003
- Version: 1.0 (EAv3.0)
- Effective date: 24-Nov-2021
This SOP describes the processes for ensuring quality in clinical research projects. This includes the approval of vendors, and the implementation and management of compliance programmes, such as the audit programme. The associated QCD provides an optional finding classification grid that can be used to grade audit findings. Whilst use of this specific QCD is optional, a predefined classification grid must be used to grade audit findings, as detailed in the Compliance Review SOP. The CRCT uses this finding classification grid when it carries out audits.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-CPR-SOP-001
- Version: 3.0
- Effective date: 08-Jan-2024
- Type: QCD (optional, but a predefined classification grid is required)
- QMS code: UoB-CPR-QCD-001
- Version: 1.0 (EAv1.0)
- Effective date: 25-Oct-2021
- Type: QCD (optional template)
- QMS code: UoB-CPR-QCD-002
- Version: 1.0 (EAv1.0)
- Effective date: 15-Aug-2022
Deviations and Serious Breach Reporting
This SOP describes the procedures to manage deviations relating to the study specific protocol and plans, good clinical Practice (GCP) or any other good practice guidelines (GxP), any applicable regulatory requirements and/or the UoB Quality Management System (QMS). The SOP also describes the procedure for serious breach reporting. The associated QCDs provide templates to evidence the management and reporting of deviations.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-DSB-SOP-001
- Version: 2.0
- Effective date: 20-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-DSB-QCD-001
- Version: 2.0
- Effective date: 15-Aug-2022
- Type: QCD (optional template)
- QMS code: UoB-DSB-QCD-002
- Version: 2.0
- Effective date: 15-Aug-2022
Study/Trial Management
This SOP describes the procedures for setting up, and obtaining the necessary approvals for, clinical research projects at the UoB. It also describes the process for making amendments to a project.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-SET-SOP-001
- Version: 2.0
- Effective date: 13-Dec-2023
Project Oversight and Quality Management
This SOP describes the procedures for establishing appropriate project oversight and quality management strategies, based on the type of the clinical research and associated risk.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-POS-SOP-001
- Version: 3.0
- Effective date: 08-Jan-2024
- Type: QCD (optional template)
- QMS code: UoB-POS-QCD-001
- Version: 1.0
- Effective date: 04-Dec-2023
Essential Documents Development and Maintenance
This SOP describes the procedure for the development, review, implementation and filing of Essential Documents, and provides further instructions and templates with regards to the development of a number of the Essential Documents, e.g. the Protocol.
- Type: SOP (applicable to both clinical trials and clinical studies)
- QMS code: UoB-ESD-SOP-001
- Version: 1.0
- Effective date: 04-Apr-2022
Protocol Template for CTIMPs *
- Type: QCD (optional template)
- QMS code: UoB-CLN-PRO-QCD-002
- Version: 1.0
- Effective date: 01-Feb-2017
- Type: QCD (optional tool)
- QMS code: UoB-ESD-QCD-003
- Version: 1.0
- Effective date: 27-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-ESD-QCD-004
- Version: 1.0
- Effective date: 27-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-ESD-QCD-005
- Version: 2.0
- Effective date: 07-Nov-2024
- Type: QCD (optional template)
- QMS code: UoB-ESD-QCD-006
- Version: 2.0
- Effective date: 07-Nov-2024
* Please note that some of our documents are currently under review and links to these documents have temporarily been removed. If you wish to access them please contact us at crct@contacts.bham.ac.uk.
This SOP explains the process of obtaining a peer review for clinical research conducted within the UoB, and provides an associated peer review letter and form template that can be used to invite and document the peer review.
- Type: SOP (applicable to both clinical trials and clinical studies)
- QMS code: UoB-PRV-SOP-001
- Version: 2.0
- Effective date: 22-Jun-2022
- Type: QCD (optional template)
- QMS code: UoB-PRV-QCD-001
- Version: 1.0
- Effective date: 15-Aug-2022
Investigator Site Management
This SOP describes the procedures involved in the set-up, initiation and closure of investigator sites. Note: for laboratories, please refer to the Laboratory Set Up and Management SOP (UoB-CRL-SOP-001).
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-SMA-SOP-001
- Version: 2.0
- Effective date: 26-Aug-2024
- Type: QCD (optional template)
- QMS code: UoB-SMA-QCD-001
- Version: 2.0
- Effective date: 07-Aug-2024
- Type: QCD (optional template)
- QMS code: UoB-SMA-QCD-002
- Version: 2.0
- Effective date: 05-Aug-2024
This SOP describes the procedures for the oversight and conduct of skeletal muscle biopsies (not intended for diagnostic purposes) in participant, and provide further instructions and template with regards to evidencing compliance to these procedures. The mandatory Biopsy Sample Permission Form is to record the authorisation of a non-physician to perform a muscle biopsy and will be valid for three years.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-SMB-SOP-001
- Version: 2.0
- Effective date: 08-Jan-2024
- Type: QCD (optional template but declaration section is mandatory when the trainee technician is a non-physician)
- QMS code: UoB-SMB-QCD-001
- Version: 2.0
- Effective date: 08-Jan-2024
- Type: QCD (mandatory form when technician is a non-physician)
- QMS code: UoB-SMB-QCD-002
- Version: 2.0
- Effective date: 08-Jan-2024
- Type: QCD (optional template)
- QMS code: UoB-SMB-QCD-003
- Version: 1.0 (EAv1.0)
- Effective date: 20-Jul-2020
- Type: QCD (optional template)
- QMS code: UoB-SMB-QCD-004
- Version: 1.0 (EAv1.0)
- Effective date: 20-Jul-2020
- Type: QCD (optional template)
- QMS code: UoB-SMB-QCD-005
- Version: 1.0
- Effective date: 04-Dec-2023
The purpose of this SOP is to describe the requirements relating to project closure. This includes notification for the end of project, early termination, and abandoned projects. It outlines the requirements for the final report on research and publications including project reports, summary reports and reporting requirements for trial registries. Furthermore, it mentions procedures for samples at the end of the project and for archiving.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-CLO-SOP-001
- Version: 2.0
- Effective date: 21-Aug-2023
This SOP describes the procedures for archiving material relevant to clinical research projects and the activities undertaken by the archivist.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-ARC-SOP-001
- Version: 2.0
- Effective date: 21-Aug-2023
- Type: QCD (optional template)
- QMS code: UoB-ARC-QCD-001
- Version: 1.0 (EAv1.0)
- Effective date: 29-Mar-2021
- Type: QCD (optional template)
- QMS code: UoB-ARC-QCD-002
- Version: 1.0 (EAv1.0)
- Effective date: 29-Mar-2021
- Type: QCD (optional template)
- QMS code: UoB-ARC-QCD-003
- Version: 2.0
- Effective date: 21-Aug-2023
Participant Safety
This SOP describes the processes involved in adverse event reporting, and provides a number of templates to help document these processes/events.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-AES-SOP-001
- Version: 2.0
- Effective date: 20-Jan-2022
- Type: QCD (optional template)
- QMS code: UoB-AES-QCD-001
- Version: 2.0
- Effective date: 24-Oct-2024
- Type: QCD (optional template)
- QMS code: UoB-AES-QCD-002
- Version: 2.0
- Effective date: 24-Oct-2024
- Type: QCD (optional template)
- QMS code: UoB-AES-QCD-003
- Version: 2.0
- Effective date: 24-Oct-2024
Please note that some of our documents are currently under review and links to these documents have temporarily been removed. If you wish to access them please contact us at crct@contacts.bham.ac.uk.
Participant Engagement and Informed Consent
This SOP describes the processes involved in participant and public engagement, to include public involvement in the study/trial design, set up and management, the development and requirements of Informed Consent Forms (ICF) and Participant Information Sheets (PIS), participant recruitment and dissemination of study/trial results to participants.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-PEI-SOP-001
- Version: 2.0
- Effective date: 20-Aug-2024
- Type: QCD (optional guidance document)
- QMS code: UoB-PEI-QCD-001
- Version: 1.0
- Effective date:17-Jul-2024
Healthy Volunteers and Medical Oversight
This SOP describes the procedures for the recruitment, management and medical oversight of healthy volunteers in clinical research.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-HVM-SOP-001
- Version: 1.0 (EAv2.0)
- Effective date: 20-Jul-2020
Data Integrity
Case Report Form (CRF) Development
This SOP describes the processes for developing and implementing a CRF for use in clinical research project.
- Type: SOP (applicable to clinical Studies and clinical trials)
- QMS code: UoB-CRF-SOP-001
- Version: 1.0
- Effective date: 21-Aug-2023
- Type: QCD (supplementary guidance to CRF Development SOP)
- QMS code: UoB-CRF-QCD-001
- Version: 1.0
- Effective date: 21-Aug-2023
Randomisation and Blinding
This SOP describes the procedures for randomisation and blinding in clinical research and describes the documentation of these procedures.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-RND-SOP-001
- Version: 1.0 (EAv1.0)
- Effective date: 17-Aug-2020
This SOP describes the data management procedures that need to be followed for a clinical research project.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-DMA-SOP-001
- Version: 1.0
- Effective date: 03-Jan-2023
This SOP describes the statistical procedures involved in clinical research conducted within the UoB.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-STA-SOP-001
- Version: 1.0
- Effective date: 20-Jan-2023
Intervention
Medicinal Product Management
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 studies and clinical trials)
- QMS code: UoB-MED-SOP-001
- Version: 1.0
- Effective date: 14-Mar-2022
Food and Nutritional Components
This SOP describes the procedures for sourcing, storage, preparation and administration of food and/or nutritional components to participants. It includes repackaging and labelling of any bulk supplies, and the disposal of excess product.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-FNC-SOP-001
- Version: 1.0 (EAv1.0)
- Effective date: 20-Jul-2020
- Type: SOP (optional template)
- QMS code: UoB-FNC-QCD-001
- Version: 1.0
- Effective date: 20-Jul-2020
- Type: QCD (optional template)
- QMS code: UoB-FNC-QCD-002
- Version: 1.0
- Effective date: 20-Jul-2020
Clinical Research in the Laboratory
Laboratory Set-Up and Management
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 clinical trials)
- QMS code: UoB-CRL-SOP-001
- Version: 3.0
- Effective date: 14-Mar-2022
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-001
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-002
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-003
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-004
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-005
- Version: 3.0
- Effective date: 03-Jan-2023
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 clinical studies and clinical trials)
- QMS code: UoB-CRL-SOP-002
- Version: 3.0
- Effective date: 14-Mar-2022
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-006
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-007
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-008
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-009
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-010
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template, but content is mandatory where in-house calibration is being performed)
- QMS code: UoB-CRL-QCD-011
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template, but content is mandatory where in-house calibration is being performed)
- QMS code: UoB-CRL-QCD-012
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template, but content is mandatory where in-house calibration is being performed)
- QMS code: UoB-CRL-QCD-013
- Version: 3.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-014
- Version: 2.0
- Effective date: 03-Jan-2023
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 clinical trials)
- QMS code: UoB-CRL-SOP-003
- Version: 3.0
- Effective date: 14-Mar-2022
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-015
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-016
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-017
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-018
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-019
- Version: 2.0
- Effective date: 03-Jan-2023
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 CTIMPs)
- QMS code: UoB-CRL-SOP-004
- Version: 4.0
- Effective date: 03-Jan-2023
- Type: QCD (mandatory for clinical trials)
- QMS code: UoB-CRL-QCD-020
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-021
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-022
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-023
- Version: 2.0
- Effective date: 03-Jan-2023
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-026
- Version: 1.0
- Effective date: 03-Jan-2023
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 CTIMPs)
- QMS code: UoB-CRL-SOP-005
- Version: 3.0
- Effective date: 14-Mar-2022
- Type: QCD (optional template)
- QMS code: UoB-CRL-QCD-024
- Version: 2.0
- Effective date: 03-Jan-2023
External Laboratory Set-up and Oversight
This SOP describes the processes involved in assessing whether an external, non-UoB laboratory is set-up in compliance with the Good Clinical Practice (GCP) laboratory standard.
- Type: SOP (applicable to CTIMPs)
- QMS code: UoB-CRL-SOP-006
- Version: 1.0
- Effective date: 14-Mar-2022
- Type: QCD (mandatory questionnaire)
- QMS code: UoB-CRL-QCD-025
- Version: 1.0
- Effective date: 03-Jan-2023