Quality Management System (QMS)

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.

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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. 

 Glossary of Terms

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@contact.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.

Clinical Research Quality Manual (Word - 567 KB)

  • 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.

UoB Principles of GCP for Clinical Research (Word - 303 KB)

  • 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. 

UoB Clinical Research Definitions (Word - 89 KB)

  • Type: Policy (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CRG-POL-002
  • Version: 1.0 (EAv1.0)
  • Effective date: 06-Jun-2019 

Sponsor Oversight for Clinical Research

The procedures for granting initial Sponsor approval for and retaining Sponsor oversight of clinical research within the UoB.

Sponsor Oversight for Clinical Research (Word - 324 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-SPO-SOP-001
  • Version: 1.0 
  • Effective date: 10-Oct-2022

Clinical Trials Task Delegation (Word - 309 KB)

  • Type: QCD (mandatory for clinical trials managed through a UoB CTU)
  • QMS code: UoB-SPO-QCD-001
  • Version: 1.0
  • Effective date: 22-Aug-2022

Sponsor Review Tool (Word - 330 KB) 

  • 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.

QMS Development and Management (Word - 366 KB) 

  • Type: SOP (applicable to all QMSs that relate to clinical research)
  • QMS code: UoB-QMS-SOP-001
  • Version: 2.0
  • Effective date: 20-Jan-2023 

Training

This SOP describes how staff training should be performed and documented, with associated QCDs to help evidence staff training.

Training (Word - 82 KB) 

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-TRN-SOP-001
  • Version: 1.0
  • Effective date: 26-Jul-2021

Employee CV Template (Word - 113 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-TRN-QCD-001
  • Version: 1.0 (EAv1.0)
  • Effective date: 24-Nov-2021

Employee Training Record Template (Word - 114 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-TRN-QCD-002
  • Version: 1.0
  • Effective date: 24-Nov-2021

Training Attendance Log (Word - 105 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-TRN-QCD-003
  • Version: 1.0 (EAv1.0)
  • Effective date: 24-Nov-2021

Compliance Review

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 findings classification grid when it carries out audits.

Compliance Review (Word - 323 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CPR-SOP-001
  • Version: 2.0
  • Effective date: 20-Jan-2023

Finding Classification Grid (Word - 125 KB)

  • Type: QCD (optional, but a predefined classification grid is required)
  • QMS code: UoB-CPR-QCD-001
  • Version: 1.0
  • Effective date: 25-Oct-2021

Site Visit Log (Word - 287 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CPR-QCD-002
  • Version: 1.0
  • 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. 

Deviations and Serious Breach Reporting (Word - 313 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-DSB-SOP-001
  • Version: 2.0
  • Effective date: 20-Jan-2023

Deviation Management (Word - 294 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-DSB-QCD-001
  • Version: 2.0
  • Effective date: 15-Aug-2022

Deviation Form (Word - 303 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-DSB-QCD-002
  • Version: 2.0
  • Effective date: 15-Aug-2022

Study/Trial Management 

Project Set-up

This SOP describes the procedures for setting up, and obtaining the necessary approvals for, clinical research projects at the University of Birmingham (UoB). It also describes the process for making amendments to a project.

Project Set-up (Word - 347 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-SET-SOP-001
  • Version: 1.0
  • Effective date: 04-Apr-2022

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. 

Project Oversight and Quality Management (Word - 337 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-POS-SOP-001
  • Version: 2.0
  • Effective date: 20-Jan-2023

Risk Assessment Template *

  • Type: QCD (optional template)
  • QMS code: UoB-CLN-TQM-QCD-001
  • Version: 1.0
  • Effective date: 10-Nov-2014

* 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@contact.bham.ac.uk. 

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. 

Essential Documents Development and Maintenance (Word - 401 KB)

  • 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

Protocol Development Tool for non-CTIMPs and Studies (Word - 320 KB)

  • Type: QCD (optional tool)
  • QMS code: UoB-ESD-QCD-003
  • Version: 1.0
  • Effective date: 27-Jan-2023

Protocol Template for non-CTIMPs and Studies (Word - 301 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-ESD-QCD-004
  • Version: 1.0
  • Effective date: 27-Jan-2023

Essential Documents Checklist (Word - 304 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-ESD-QCD-005
  • Version: 1.0
  • Effective date: 27-Jan-2023

Version Control Log (Word - 316 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-ESD-QCD-006
  • Version: 1.0
  • Effective date: 27-Jan-2023

* 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@contact.bham.ac.uk. 

Peer Review

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. 

Peer Review (Word - 363 KB)

  • Type: SOP (applicable to both clinical trials and clinical studies)
  • QMS code: UoB-PRV-SOP-001
  • Version: 2.0
  • Effective date: 22-Jun-2022

Peer Review Letter and Form Template (Word - 86 KB)

  • 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 UoB-CRL-SOP-001 Laboratory Set Up and Management.

Investigator Site Management (Word - 318 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-SMA-SOP-001
  • Version: 1.0
  • Effective date: 14-Mar-2022

Site Signature and Delegation Log (Word - 296 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-SMA-QCD-001
  • Version: 1.0
  • Effective date: 24-Jun-2022

Site Initiation Checklist (Word - 295 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-SMA-QCD-002
  • Version: 1.0
  • Effective date: 22-Jun-2022

Skeletal Muscle Biopsies

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.

Skeletal Muscle Biopsies (Word - 309 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-SMB-SOP-001
  • Version: 1.0 (EAv1.0)
  • Effective date: 20-Jul-2020

Biopsy Training Programme and Record (Word - 102 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-SMB-QCD-001
  • Version: 1.0
  • Effective date: 20-Jul-2020

Biopsy Sampling Permission Form (Word - 103 KB)

  • Type: QCD (mandatory form)
  • QMS code: UoB-SMB-QCD-002
  • Version: 1.0
  • Effective date: 20-Jul-2020

Anaesthetic Stock Control Form (Word - 104 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-SMB-QCD-003
  • Version: 1.0
  • Effective date: 20-Jul-2020

Biopsy Record Form (Word - 102 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-SMB-QCD-004
  • Version: 1.0
  • Effective date: 20-Jul-2020

Project Closure

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.

Project Closure (Word - 77 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CLO-SOP-001  
  • Version: 1.0
  • Effective date: 22-Mar-2021

Archiving

This SOP describes the procedures for archiving material relevant to clinical research projects and the activities undertaken by the archivist.

Archiving (Word - 198 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-ARC-SOP-001
  • Version: 1.0
  • Effective date: 29-Mar-2021

Archiving Plan (Word - 104 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-ARC-QCD-001
  • Version: 1.0
  • Effective date: 29-Mar-2021

Archive Label (Word - 102 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-ARC-QCD-002
  • Version: 1.0
  • Effective date: 29-Mar-2021

Guide to Retention Times (Word - 104 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-ARC-QCD-003
  • Version: 1.0
  • Effective date: 29-Mar-2021

Participant Safety

Adverse Event Reporting

This SOP describes the processes involved in adverse event reporting, and provides a number of templates to help document these processes/events.

Adverse Event Reporting (Word - 459 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-AES-SOP-001
  • Version: 2.0
  • Effective date: 20-Jan-2022

Serious Adverse Event (SAE) Form Template (Word - 312 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-AES-QCD-001
  • Version: 1.0
  • Effective date: 15-Aug-2022

Internal Process Example for Serious Adverse Event (SAE) Handling (Word - 318 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-AES-QCD-002
  • Version: 1.0
  • Effective date: 15-Aug-2022

Pregnancy Notification Form (Word - 294 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-AES-QCD-003
  • Version: 1.0
  • Effective date: 15-Aug-2022

Development Safety Update Report (DSUR) Template (Word - 164 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CLN-AES-QCD-004
  • Version: 3.0
  • Effective date: 01-Jan-2016

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.

Participant Engagement and Informed Consent (Word - 130 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-PEI-SOP-001
  • Version: 1.0 (EAv1.0)
  • Effective date: 23-Sep-2019

Informed Consent Procedure for Site Staff *

  • Type: QCD (guidance document)
  • QMS code: UoB-CLN-ESD-QCD-004
  • Version: 1.0
  • Effective date: 17-Jun-2015

* 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@contact.bham.ac.uk. 

Healthy Volunteers and Medical Oversight

This SOP describes the procedures for the recruitment, management and medical oversight of healthy volunteers in clinical research.

Healthy Volunteers and Medical Oversight (Word - 308 KB)

  • 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 trials.

CRF Development (Word - 123 KB)

  • Type: SOP (applicable to clinical trials only)
  • QMS code: UoB-CRT-CRF-SOP-001
  • Version: 1.0 (EAv3.0)
  • Effective date: 24-May-2017

Guide to CRF Development (Word - 102 KB)

  • Type: QCD (supplementary guidance to CRF Development SOP)
  • QMS code: UoB-CRT-CRF-QCD-001
  • Version: 1.0 EAv1.0
  • Effective date: 10-Apr-2018

Randomisation and Blinding

This SOP describes the procedures for randomisation and blinding in clinical research and describes the documentation of these procedures.

Randomisation and Blinding (Word - 370 KB)

  • 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

Data Management

This SOP describes the data management procedures that need to be followed for a clinical research project.

Data Management (Word - 316 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-DMA-SOP-001
  • Version: 1.0
  • Effective date: 03-Jan-2023

Statistics

This SOP describes the statistical procedures involved in clinical research conducted within the UoB.

Statistics (Word - 379 KB)

  • 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).

Medicinal Product Management (Word - 406 KB)

  • 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. 

Food and Nutritional Components (Word - 310 KB)

  • 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

Receipt and Storage Record (Word - 99 KB)

  • Type: SOP (optional template)
  • QMS code: UoB-FNC-QCD-001
  • Version: 1.0
  • Effective date: 20-Jul-2020

Accountability Log (Word - 101 KB)

  • 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.

Laboratory Set-Up and Management (Word - 360 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CRL-SOP-001
  • Version: 3.0
  • Effective date: 14-Mar-2022

Setting up a Laboratory Master File (Word - 297 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-001
  • Version: 3.0
  • Effective date: 03-Jan-2023

Laboratory Roles and Duties (Word - 297KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-002
  • Version: 3.0
  • Effective date: 03-Jan-2023

Laboratory Competencies (Word - 292 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-003
  • Version: 2.0
  • Effective date: 03-Jan-2023

Laboratory Contracts and Agreements Checklist (Word - 292 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-004
  • Version: 3.0
  • Effective date: 03-Jan-2023

Key Contracts (Word - 293 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-005
  • Version: 3.0
  • Effective date: 03-Jan-2023

Laboratory Facilities

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. 

Laboratory Facilities (Word - 357 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CRL-SOP-002
  • Version: 3.0
  • Effective date: 14-Mar-2022

Housekeeping Schedule (Word - 302 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-006
  • Version: 2.0
  • Effective date: 03-Jan-2023

Temperature Monitoring (Word - 296 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-007
  • Version: 3.0
  • Effective date: 03-Jan-2023

Refrigerator or Freezer Failure Management (Word - 295 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-008
  • Version: 2.0
  • Effective date: 03-Jan-2023

Equipment Fitness for Use and User Acceptance Testing (Word - 296 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-009
  • Version: 3.0
  • Effective date: 03-Jan-2023

Equipment Maintenance Schedule (Word - 297 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-010
  • Version: 2.0
  • Effective date: 03-Jan-2023

Calibration of Balances (Word - 296 KB)

  • 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

Calibration of Thermometers (Word - 295 KB)

  • 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

Calibration of Single-channel and Multi-channel Pipettes (Word - 302 KB)

  • 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

Computerised System and User Access Levels (Word - 294 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-014
  • Version: 2.0
  • Effective date: 03-Jan-2023

Sample Management

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.

Sample Management (Word - 359 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CRL-SOP-003
  • Version: 3.0
  • Effective date: 14-Mar-2022

Clinical Sample Kits (Word - 302 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-015
  • Version: 2.0
  • Effective date: 03-Jan-2023

Managing Withdrawal of Consent in the Laboratory (Word - 292 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-016
  • Version: 2.0
  • Effective date: 03-Jan-2023

Sample Transport (Word - 292KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-017
  • Version: 2.0
  • Effective date: 03-Jan-2023

Sample Receipt, Labelling, Tracking and Storage (Word - 294KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-018
  • Version: 2.0
  • Effective date: 03-Jan-2023

Processing of Damaged, Unexpected or Mislabelled Samples (Word - 294 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-019
  • Version: 2.0
  • Effective date: 03-Jan-2023

Laboratory Analysis

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.

Laboratory Analysis (Word - 306 KB)

  • Type: SOP (applicable to CTIMPs)
  • QMS code: UoB-CRL-SOP-004
  • Version: 4.0
  • Effective date: 03-Jan-2023

Assay Validation (Word - 298 KB)

  • Type: QCD (mandatory for clinical trials)
  • QMS code: UoB-CRL-QCD-020
  • Version: 2.0
  • Effective date: 03-Jan-2023

Computerised System Validation Plan (Word - 293 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-021
  • Version: 2.0
  • Effective date: 03-Jan-2023

Analytical Plans (Word - 299KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-022
  • Version: 2.0
  • Effective date: 03-Jan-2023

Review and Release of Results (Word - 291 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-023
  • Version: 2.0
  • Effective date: 03-Jan-2023

Assay Validation Flow Cytometry Guidance (Word - 303 KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-026
  • Version: 1.0
  • Effective date: 03-Jan-2023

Reportable Issues

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.

Reportable Issues (Word - 302 KB)

  • Type: SOP (applicable to CTIMPs)
  • QMS code: UoB-CRL-SOP-005
  • Version: 3.0
  • Effective date: 14-Mar-2022

Reportable Issues (Word - 292 KB)

  • 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.

External Laboratory Set-up and Oversight (Word - 365 KB)

  • Type: SOP (applicable to CTIMPs)
  • QMS code: UoB-CRL-SOP-006
  • Version: 1.0
  • Effective date: 14-Mar-2022

External Laboratory Self-Assessment Questionaire (Word - 309KB)

  • Type: QCD (optional template)
  • QMS code: UoB-CRL-QCD-025
  • Version: 1.0
  • Effective date: 03-Jan-2023