Frequently Asked Questions (FAQs)

Adhering to the QMS not only ensures regulatory and ethical compliance but also enhances the quality and credibility of your research. It supports your personal and professional development while protecting both the university and the participants involved in your research.

Listed below are some of the key reasons to follow the UoB QMS.

1. Ensures Compliance with University and Regulatory Standards

• Following the QMS ensures that your research is compliant with both internal policies and external regulations, reducing the risk of legal or ethical violations.

2. Protects Research Integrity

• Adherence to the QMS assures that your research follows established standards, helping ensure the accuracy, reliability, and reproducibility of your results.

3. Safeguards Participant Safety

• The QMS ensures that participant safety is prioritised by providing SOPs and QCDs for informed consent, risk assessments, and adverse event reporting. Failing to follow these QMS documents could lead to participant harm and reputational damage.

4. Prepares for Audits and Inspections

• Universities are regularly audited by regulators, funding bodies, and accrediting agencies. By adhering to the QMS, you ensure that your research is fully prepared for inspections and audits. This also makes it easier to respond to requests for documentation or evidence of compliance.

5. Improves Research Outcomes

• When you follow the QMS, you gain expert advice, and resources for quality assurance. This can improve your research outcomes and help you solve problems that arise during the project.

6. Facilitates Funding and Collaboration Opportunities

• Many funding agencies and potential collaborators require adherence to a formal QMS as part of their eligibility criteria. Compliance with the QMS may enhance your chances of securing grants and fosters trust in collaborative projects.

7. Minimises Risks of Delays or Rejections

• Deviating from the QMS can lead to delays in approvals or even the rejection of your project by ethics committees or regulatory bodies. Adhering to the system ensures that all necessary processes are followed, reducing the risk of setbacks.

8. Consistency in Processes

• Following the standard operating procedures (SOPs) ensures that all research team members follow the same protocols, promoting uniformity across the project and reducing variability in research activities.

 9. Contributes to Continuous Improvement

• Following the QMS also means contributing to its refinement. Your adherence provides feedback to the university, helping improve processes and fostering a culture of continuous improvement in clinical research quality.

10. Ethical Responsibility

• Following the QMS will help you to conduct research in an ethical, transparent, and accountable manner.

To efficiently find the documents you need in the Quality Management System (QMS), follow the steps below.

1. Understand the Document Code

• Code Structure: each QMS document has a unique code that helps you identify its topic and type e.g. UoB-PEI-SOP-001.How it Helps: the code helps you locate and understand the document’s focus area within the QMS.

  • Part 1: "UoB" signifies that it's a University of Birmingham document.
  • Part 2: three letters representing the QMS topic area (e.g. "PEI" for participant engagement and informed consent in the example given).
  • Part 3: three letters identifying the document type (e.g. "SOP" for standard operating procedure).
  • Part 4: a unique three-digit number (e.g. "001").

2. Understand the Overall QMS Structure

The QMS is divided into six broad categories:

1. Governance Infrastructure: research governance and compliance policies.

2. Study/Trial Management: procedures for setting up and managing clinical research projects.

3. Participant Safety: requirements for ensuring participant safety.

4. Data Integrity: standards for data management and accuracy.

5. Intervention: documents related to interventions and medical oversight in research.

6. Clinical Research in the Laboratory: procedures for setting up and managing a laboratory.

3. Identify the Relevant Category

• Start by determining which category applies to your specific query or research task.

  • Example: if you are working on setting up a study, go to the Study/Trial Management category.

4. Choose the Topic-Based Subsection

•  Within each category, there are subsections that focus on more specific tasks.

  • Example: for clinical study setup, go to the project set-up subsection within Study/Trial Management.

5. Access the Documents (Policies, SOPs, QCDs)

• Once you select the relevant subsection, you’ll find documents within it.
  • Policies: high-level guidelines and principles.
  • SOPs (standard operating procedures): detailed, step-by-step procedures.
  • QCDs (quality control documents): tools to monitor and document adherence to the SOPs.
• Recommendation: follow this reading order—Policy --- SOP --- QCD—to understand both the overarching framework and the specific steps required.

Example

• If you need guidance on adverse event reporting:
  1. navigate to the Participant Safety category
  2. select the adverse event reporting subsection
  3. access the SOP that outlines the reporting process
  4. review any relevant QCDs for documentation and quality checks.

6. Follow Document Links and References

• Internal references: the QMS documents often reference other documents, such as related SOPs or policies. Following these links can lead you to additional resources, ensuring you have complete information.

7. Ask for Help

• If you are unable to locate the necessary documents or are unsure about specific procedures, reach out to the Clinical Research Compliance Team (CRCT) for assistance.

By understanding the QMS structure and using the document codes, categories, and internal links, you’ll efficiently find the necessary documents and ensure compliance with relevant guidelines.

Policies

• Policies provides a high-level overview of the rules, principles, and governance frameworks that guide clinical research at the university. These documents will help you understand the general expectations, ethical standards, and regulatory requirements that apply to your research project.
• Note: The Clinical Research Quality Manual (UoB-CQM-POL-001) is used to collate several policies relating to the UOB QMS and its development.
• How policies help you: policies set the foundation for compliance and guide your overall approach to managing the research project. 

Standard Operating Procedures (SOPs)

• SOPs break down the policies into actionable steps and detailed procedures for carrying out specific tasks. If you’re dealing with questions about how to perform a specific action (e.g. adverse event reporting), SOPs provide the step-by-step guide you need.

• • How SOPs help you: SOPs ensure that you perform tasks consistently and in compliance with regulations and policies, protecting the integrity of your research.

 Quality Control Documents (QCDs)

• QCDs are a useful tool to verify and monitor that the procedures outlined in the SOPs are being followed correctly. They help ensure that outputs meet quality standards and provide documentation e.g. for audits, training, or delegation of tasks. Some QCDs are mandatory, see ‘How do I know if a QMS document is applicable to my project?’ to learn how you can identify mandatory vs optional QCDs.
•  How QCDs help you: QCDs are your tools for ongoing monitoring, providing evidence that your project adheres to expected quality standards and that the SOPs are followed correctly.

To determine whether a QMS document (such as a SOP, policy, or QCD) is applicable to your clinical research, follow the steps below.

1. SOPs and Policies

A. Review the SCOPE Section

• The SCOPE section in a SOP or policy will specify the types of projects it applies to. Check whether your project fits into any of the categories listed.
  • University of Birmingham-Sponsored Clinical Research: if your project is sponsored by the UoB, the SOP/Policy will be mandatory.
  • Externally Sponsored Clinical Research: if your project is sponsored by another institution, the SOP/Policy is relevant unless it conflicts with the agreement between the UoB and the sponsor.
  • Research Approved by a UoB Research Ethics Committee (REC): if your project has received UoB REC approval, and the committee requires compliance with the UoB Principles of Good Clinical Practice (GCP) for Clinical Research (UoB-GCP-POL-001), the SOP/Policy applies.

B. Check Sponsorship and Ethical Approval

• University of Birmingham-Sponsored Clinical Research: if your project is sponsored by the UoB, the SOP/Policy will be mandatory.
• Externally Sponsored Clinical Research: if your project is sponsored by another institution, the SOP/Policy is relevant unless it conflicts with the agreement between the UoB and the sponsor.
• Research Approved by a UoB Research Ethics Committee (REC): if your project has received UoB REC approval, and the committee requires compliance with the UoB Principles of Good Clinical Practice (GCP) for Clinical Research(UoB-GCP-POL-001), the SOP/Policy applies.

C. Check Sponsorship and Ethical Approval

• University-Sponsored Research: if the UoB directly sponsors your research, the SOP/Policy is generally mandatory unless there’s a stated exception.

• Other Sponsors: for externally sponsored projects, ensure there are no conflicts between the SOP/Policy and the sponsor's contractual terms.

• UoB REC Requirements: If the UoB REC mandates adherence to the UoB Principles of GCP for Clinical Research (UoB-GCP-POL-001), the SOP/Policy becomes compulsory.

D. Consult the Clinical Research Compliance Team (CRCT)

• If unsure about the relevance of a document, consult the CRCT or the university’s Research Governance, Ethics and Integrity team (REGI). They can confirm whether a specific QMS document is mandatory for your project.

Summary for SOPs and Policies

• Scope Section: check if your research falls under UoB sponsorship, external sponsorship, or UoB REC approval.

• Sponsorship: determine if your study is UoB-sponsored or backed by another institution.

• Ethics Committee Requirements: verify if adherence to specific standards is required by the UoB REC.

• Consultation: reach out to the CRCT/REGI for confirmation and guidance.

2. Quality Control Documents (QCDs)

• Mandatory vs Optional: most QCDs are optional for all types of research projects, unless otherwise stated within the document. If a QCD is mandatory, this will be explicitly mentioned.

Understanding Mandatory vs. Recommended Procedures in QMS Documents

When navigating QMS documents like SOPs, policies, and QCDs, it’s essential to recognise whether certain procedures are mandatory or recommended.

1. Specificity to Research Type

• Application to Specific Projects: certain procedures may only apply to specific types of research, such as clinical trials or studies. These distinctions are clearly noted in the document. For example, a certain section of a SOP might only apply to clinical trials and not observational studies.

2. Language Used in SOPs and Policies

• The terminology within the documents determines whether compliance is mandatory or recommended.

Mandatory Requirements

• Terminology: QMS documents use the word “will” in place of strict terms like "must," "required," "requirement," and "shall" to convey a non-negotiable action.
• Example: “The CI (or delegate) will confirm that all relevant local approvals are in place...”.
• Meaning: This implies that the action must be completed without exception.

• Guidance Terminology

  • Terminology: the phrase “it is expected” replaces softer terms like "should," suggesting that the action is strongly advised but not obligatory.
  • Example: “for project using profiling or automatic decision making, it is expected that UoB Legal Services is contacted for advice on how to include the necessary working for the privacy notice”.
  • Meaning: there is flexibility in how this requirement can be met, but it is recommended.

• Good Practice Terminology

  • Terminology: “Recommended” is used to indicate best-practice advice that is not mandatory but supports better outcomes.
  • Example: “It is recommended to use a site initiation checklist template to document that site-initiation activities undertaking and provide a reference point for site initiation”.
  • Meaning: Following this advice enhances project quality, but it is optional.

Key Takeaways

1.  SOP/Policy Relevance

   • Check the SCOPE section of the document to verify whether it applies to your project, based on factors like sponsorship, ethical approval, or project type.
   • If unsure, consult the Clinical Research Compliance Team (CRCT) or Research Governance, Ethics and Integrity (REGI).

2.  QCD Applicability

   • Most Quality Control Documents (QCDs) are optional, except where stated otherwise. Check the document for specific project applicability (e.g. clinical trials).

3.  Mandatory vs. Recommended Actions

   • Mandatory Actions: look for the term “will” to identify strict requirements that must be followed.
   • Guidance Actions: look for the phrase “it is expected” to identify recommendations that allow some flexibility.
   • Best Practice Recommendations: look for the term “recommended” to spot actions that are advised for better outcomes but not required.

By recognising these distinctions, you can ensure compliance with mandatory procedures and understand when guidance or best practice is encouraged but not required for your clinical research project.

You should start using the QMS as early as possible, and ideally at the beginning of the research process. You should continue to use it throughout the entire lifecycle of your project, as it will guide you from protocol development, participant recruitment, and data collection through to monitoring, reporting, and project closure. It ensures compliance, maintains quality, and reduces risks at every stage of the project.

See the clinical research e-Pathway for a roadmap to help you navigate the regulatory requirements from your initial idea to getting your project published. The e-Pathway will help signpost you to key documents and systems and connect you to the teams that can help.

Please note that the Clinical Research QMS does not cover pre- and post-award procedures such as grant applications, setting up contracts & awards or budget monitoring. Please contact your College Research Support Hub (UoB login required) for support with this.

At the end of each SOP, there is a list of expected outputs that summarises in an easy-to-use list, the specific results or deliverables that must be achieved. These outputs are benchmarks to confirm compliance with the SOP.

By using the list of expected outputs, you cantrack that your project meets all the required standards and compliance measures.

1. Align Project Activities with Expected Outputs

• Ensure that project activities are structured around achieving the listed outputs.

• Ensure that your research tasks and processes (e.g. ethical approvals, data collection, safety reporting) are designed to meet the specific requirements outlined in the SOP’s outputs section. The use of associated QCDs can help with this task.

2. Create a Checklist Based on Expected Outputs

• Use the expected outputs to create a checklist. This makes it easier to track progress and ensure that nothing is overlooked.

• As you move through your project, you can use this checklist to confirm that each output has been completed or is on track.

3. Consult with Your Research Team

• If the expected outputs require actions from multiple team members, make sure everyone is aware of the outputs they are responsible for. Coordination and delegation are key to ensuring that all outputs are achieved.

4. Review Outputs Before Submitting or Closing a Project

• Before you submit any reports or close your project, revisit the expected outputs section to verify that all required outputs have been met.

• This final check helps avoid missing important steps that could compromise your project’s compliance or quality.

Following this approach ensures that your project adheres to the SOP’s requirements and meets the expected standards for quality, compliance, and regulatory adherence.

To ensure you have the latest version of a QMS document and to track updates, see below for the steps and key elements to look for.

1. Check the Document’s Cover Page for Effective Date and Version Control

• Effective Date: look for the effective date on the cover page that indicates when the document was last issued.

• Version Number: check the version number of the document that you are using (e.g. v1.0, v2.0, v3.0). Where a revision to the document has been made that does not affect the key content and/or requirements outlined in the document, the version number will follow with an ‘editorial amendment’ version number (e.g. v1.0 (EAv1.0), v1.0 (EAv2.0), v1.0 (EAv3.0).

• How It Helps: this information allows you to confirm if your document is current by comparing it with other documents.

2. Check the QMS Document Repository

• Access the Repository: visit the online QMS document repository where the latest documents are stored.

• Compare Versions: ensure that the version number and effective date on your document match the latest one available online. Please note that QMS documents are controlled documents, and any unauthorised prints/downloads of these documents will be classed as uncontrolled.

• How It Helps: the repository is always up to date, so this ensures you are working with the most recent version of any QMS document.

3. Contact the CRCT Team

• If you’re unsure or cannot access the repository, contact the Clinical Research Compliance Team (CRCT) for clarification. They can confirm the document’s version and direct you to the latest copy.

• How It Helps: the CRCT maintains the QMS and provide real-time verification if needed.

4. Review Internal Documentation

• Conduct regular internal reviews to check that the version numbers and effective dates of the documents you’re using match those in the repository.

• How It Helps: this ensures compliance with the most current procedures and avoids accidental use of outdated documents.

By following these steps, you can confidently confirm that you have the most up-to-date version of any QMS document and know how to locate or check updates within the system.

Regularly checking the QMS is essential for staying compliant with regulations, ensuring participant safety, maintaining data integrity, preparing for audits, and keeping up with continuous improvements. It helps you avoid errors, prevent issues from escalating, and ensures that your research aligns with university and regulatory standards.

Ensure Compliance with Regulatory Changes

• Regulations governing clinical research, such as Good Clinical Practice (GCP), HRA, MHRA guidelines, and UoB QMS or institutional policies, are frequently updated. Regularly checking the QMS helps ensure that your project adheres to the most current legal and ethical requirements.

Stay Up-to-Date with Policies and SOPs

• The CRCT periodically revise standard operating procedures (SOPs) and policies to reflect new standards, technologies, or regulatory requirements. Regular checks ensure you’re always using the latest and most relevant procedures.

Prepare for Audits and Inspections

• External audits by regulatory bodies or internal audits by the CRCT are a standard part of clinical research. By regularly checking the QMS, you ensure that your project always remains audit-ready.

Facilitate Continuous Improvement

• Regular engagement with the QMS allows you to contribute to and benefit from continuous improvement initiatives. By staying informed about updates, feedback, and best practice, you can improve the quality and efficiency of your research.

Protect University and Personal Reputation

• Your adherence to the QMS not only impacts the success of your research but also protects the reputation of both the university and you as a researcher. Regular checks ensure that you’re following the highest standards of quality and compliance.

To quickly see the changes made to a QMS document since its most recent revision, follow the steps outlined below.

Look for the Revision History

• Location: at the end of the QMS document there is a section titled "Document History".

• Content: this section lists all previous versions of the document, along with a brief summary of the changes made in each version.

• How it helps: by reviewing this section, you can quickly identify any updates or modifications, allowing you to adjust your project processes accordingly to ensure compliance.

Key Benefits

• Saves time: you can immediately see what’s new without having to reread the entire document and work out the differences between the versions.

• Ensures compliance: helps ensure that you are following the most current procedures, preventing errors or non-compliance in your research project.

This process makes it simple to stay informed about important updates in a QMS document.

If you notice conflicting statements in QMS documents, please follow the steps below.

Check the Effective Dates

• Review the effective dates of the conflicting documents. The document with the most recent effective date is considered to supersede the older one (unless otherwise indicated) as it reflects the most up-to-date procedures or policies.

 Inform the CRCT

• Inform the Clinical Research Compliance Team (CRCT) of the conflicting statements in QMS documents.
• If the conflict is unclear or if both documents seem equally applicable, the CRCT can also provide guidance on which document takes precedence and whether the older document is due to be updated.

Wait for Document Updates

• The CRCT will work to update the older document to reflect the most current information. Be sure to check for updates regularly to stay compliant with the latest requirements.

Key Steps

• Review the effective dates.

• Follow the latest document.

• Inform the CRCT (and consult with the CRCT if unsure).

• Monitor for updates.

This process ensures that you're following the most accurate and up-to-date guidance for your project.

If a change to a process/procedure in the QMS is required, a request should be made to the CRCT. 

Ethics review is one of the keyways in which the University seeks to protect all stakeholders in its research projects, including both participants and researchers.  As such, the requirement for appropriate ethics review is part of the University’s Code of Practice for Research. For more information, see ‘Research Ethics - what do I need to do?’. 

Broadly speaking, a clinical study uses human participants or human data to evaluate biomedical or health-related outcomes. Clinical studies are considered to be observation based and includes; studies administrating questionnaires/interviews, studies limited to working with human tissue samples and/or data and physiology studies involving human volunteers. 

In contrast, a clinical trial involves an intervention whereby you are changing what the participant would do in their normal setting. These are aimed at evaluating a medical, surgical, behavioural, and/or dietary intervention. Clinical trials can often further sub-divided into a CTIMP and non-CTIMP. Whereby a CTIMP is a clinical trial of an Investigational Medicinal Product to determine its safety, efficacy, clinical effectiveness, or pharmacological or pharmacodynamic effects.

For more information see the UoB Clinical Research Definitions (Word - 92 KB), where you will also find the MHRA's algorithm to help you determine whether your clinical research projects is a CTIMP, non-CTIMP or study. 

Yes, if your clinical research project is to be / has been approved by the Health Research Authority (HRA) as per the UoB Principles of GCP for Clinical Research (Word - 84 KB). 

This includes studies that go through UoB REC but still require HRA approval. All other research projects (without HRA approval) do not require registration on a public database though it is good practice.

The reason for this is to help avoid waste through unnecessary duplication of research. Therefore, information about research projects (other than those for educational purposes) is to be made publicly available before it starts (unless a deferral is agreed by or on behalf of the research ethics committee). 

The Clinical Trials Oversight Committee at the University has developed some guidance on the different types of registries available for UoB sponsored projects (PDF - 218 KB).  Please contact researchgovernance@contacts.bham.ac.uk for further information. 

Currently, some projects submitted through IRAS are automatically registered on the ISRCTN Registry e.g. when Portfolio adapted (see the NIHR ISRCTN registration for more information) by the HRA.

Further information on project registration can also be found online:

• The HRA has guidance on Research registration and research project identifiers. 

• The HRA also produces guidance on Research Transparency.

Please contact researchgovernance@contacts.bham.ac.uk if you have any questions regarding project registration.

The university has insurance in place that provides cover for clinical trials in which the university participates, including those it sponsors. The term clinical trials is used here to refer to all types of clinical research projects i.e. studies and trials. Some exclusions apply to the university’s clinical-trials insurance cover, and these must be discussed with the Research Ethics, Governance and Integrity Team (REGI) prior to, or during, the sponsorship-review process.

The university’s insurance cover is renewed annually, at which time a new certificate is issued. For clinical research projects that fall under this standard clinical-trials insurance cover, the latest certificate can be downloaded from the intranet. See Clinical trials activities and Insurance Cover (PDF - 561 KB) for the latest certificate. For copies of previous certificates, please contact the REGI.

Where a project isn’t covered by the university’s standard clinical-trials insurance, the project-specific insurance certificate should be filed in the study/trial master file (S/TMF).

REGI

REGI stands for Research Ethics, Governance and Integrity Team. The team manages the University of Birmingham’s sponsorship of clinical research projects, in line with the principles of good practice set out in the UK Policy Framework for Health and Social Care Research. If you are interested in UoB sponsorship for a clinical research project, see Applying for University of Birmingham Sponsorship.

You should also contact the REGI if you have any queries regarding their other areas of responsibility, as listed below.

• Reporting: throughout the duration of the research, the REGI will monitor annual report submissions to the Research Ethics Committee (REC) and if applicable, to a competent authority such as the MHRA.

• Site agreement: the REGI is responsible for establishing agreements with participating sites.

• Insurance: the REGI ensures that research projects have appropriate insurance cover.

The REGI also facilitates the University’s research ethics processes for all staff and postgraduate student research projects. The team works with the University’s Humanities and Social Sciences (HASS) and Science, Technology, Engineering and Mathematics (STEM) research ethics committees to ensure that all research projects requiring University ethics review receive this as appropriate. For more information, see Research ethics – what do I need to do?

CRCT

CRCT stands for Clinical Research Compliance Team (CRCT). The CRCT helps to ensure clinical research projects, in particular clinical trials, are conducted in line with any applicable regulations, international standards, and the university’s own standards.

The CRCT develops and maintains the UoB Quality Management System (QMS), and supports researchers in developing their own documentation. The team also provides training and support to researchers, to help them to ensure that their clinical research projects comply with applicable regulations and standards.

The CRCT is responsible for carrying out compliance reviews across the university’s clinical research portfolio. The CRCT assesses a project’s compliance against applicable regulations and standards, using either the:

• sponsor support visit (SSV) programme

• audit programme.

For further detail about SSVs and audits, see the FAQ ‘What is the difference between an SSV and an audit?’

How does an NHS trust’s R&D department fit in?

R&D stands for research and development. If a clinical research project uses NHS premises, or involves NHS participants (staff or patients), researchers will need additional approval from the relevant NHS trust’s R&D department. This approval process is automatically included as part of the Health Research Authority (HRA) approval completed via the Integrated Research Application System (IRAS). However researchers are encouraged, at an early stage, to liaise directly with the relevant trust’s R&D department to ensure that the trust is able to facilitate the proposed research project. 

A Health and Safety Risk Assessment is required for all research prior to the research commencing. See Safety Services for more information.

In addition, for clinical research a separate project-specific risk assessment should be performed, which will include an assessment of the risks related to the research design and method, participant safety and reliability of the data/results.

Please see the UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB) for further details on carrying out a risk assessment. 

Within in the UoB Clinical Research QMS there are several tools you can use to help with the development of your essential documents. There are protocol templates for both CTIMPs and non-CTIMPs and studies (see also UoB Essential Document Development & Maintenance SOP (UoB-ESD-SOP-001) (Word – 401 KB)). These templates provide the structure for the protocol as well as instructional text throughout which provides an insight into what each section should include. Both of these templates are developed in line with the HRA requirements.

The Sponsor Review Tool (UoB-SPO-QCD-002) (Word - 330 KB) provides additional information on what should be included in each section of the protocol, as well as what information should be included in your Informed Consent Form, Participant Information Sheet and the IRAS form.

The HRA also have provided their own guidance and templates for the development of protocols, Informed Consent Forms and Participant Information Sheets.

In the CRCT we also provide a project set-up support service for researcher who require some additional support in the development of their study documents. This service is available to all researchers, but is perfect for PhD students or those setting up a clinical research project for the first time. For more information about project set-up support please contact us. 

Please also visit the clinical research e-Pathway that provides a roadmap to guide researchers during the lifetime of their research project including the setup of essential documents. 

A Sponsor Support Visit (SSV) is a facilitative visit to the investigator and research team. We will discuss and review your project, including key processes and documents such as the participant consent and enrolment, the collection and processing of study data and tissue sample management, as applicable. The visit allows us to share best practice between teams, as well as providing suggestions where areas of work might need further attention to ensure full adherence to applicable regulations and standards. SSVs usually look at one research project at a time and focuses on one of the following themes: Good Clinical Practice (GCP),  or Human Tissue across the whole project. 

Audits are used to assure adherence to our QMS which includes current legislation, standards and guidelines.  In some circumstances they may be used to assure adherence with other (local or external) QMSs. Any findings identified will need a response from the research team which must be in the form of a Corrective Action and Preventative Action (CAPA) plan.

Why have I been selected?

Currently both SSVs and audits are selected at random using a risk-based approach to identify potential clinical research projects

There are a variety of training courses and workshops by the CRCT available to support UoB staff and PhD students involved in research with participants. For example, an introduction to clinical research workshop, a delegation of duties training session and a workshop on conducting clinical research in a UoB laboratory. We always offer some online training via canvas that can be accessed all year round. Further information and links to this and other training can be found on our Training and Workshop page.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical research that involve the participation of human volunteers. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable.

Do I need to be trained in it?

Staff members who are involved in the day-to-day (site) management of a CTIMP (e.g. Chief Investigator, Research Nurse, Trial Coordinator) are required to have completed the National Institute for Health Research (NIHR) GCP training online course. In addition, staff members have to ensure (and be able to evidence) they stay up to date with their knowledge of GCP and applicable regulations, for example through completing the NIHR GCP refresher courses every 3 years as per the UoB Clinical Research Quality Manual. 

Relevant material as defined by the Human Tissue Act is material, other than gametes, which consists of or includes human cells. This includes (but not limited to); bone marrow, faeces, platelets, saliva, teeth and urine. It does not include embryos outside the human body, or hair and nail from the body of a living person. See also the Human Tissue Authority (HTA) for a list of materials considered to be ‘relevant material’ under the Human Tissue Act 2004. 

Where UoB staff are involved in the handling, processing, receipt, storage or analysis of relevant material the following two laboratory specific UoB SOPs are applicable: 

• Laboratory Set-Up and Management (Word - 86 KB)

• Laboratory Facilities (Word - 122 KB)

• Sample Management (Word - 124 KB)

Please note: other UoB SOPs may be applicable to your research. If you are working with human samples as part of a clinical trial, you must also follow:

• Laboratory Analysis (Word - 83 KB)

• Reportable Issues (Word - 77 KB)

To access all the UoB SOPs and related documents, see the UoB Clinical Research QMS.

A Material Transfer Agreement (MTA) is a type of contract that covers the transfer of materials from one party to another. They can be used for all types of material, but in clinical research they are most commonly associated with the transfer of human biomaterials. A MTA will set out who is the owner of the material being provided and the permitted use of the materials in question for the other party. A MTA can be either “Outgoing” where the University is providing the materials or “Incoming” where we are receiving materials.

If you intend on transferring human biomaterial a MTA must be in place prior to samples being shipped to or from the University.

For trials and studies which have been approved by the Health Research Authority, material transfer may be covered by Appendix 3 of the Organisation Information Document (OID - formerly the Statement of Activities) – Material Transfer Provisions, which allows the Sponsor and participating organisations to agree to the transfer of human biomaterial (including relevant material as defined by the Human Tissue Act). For more information please see the OID guidance (PDF - 267KB). The material transfer may also be included in the Clinical Trial Agreement. However, if the transfer of human biomaterial is not covered by the either of these or the research is not being approved by the HRA, please contact UoB Contracts Team for support.

Good Manufacturing Practice (GMP) is a recognised standard for pharmaceutical manufacturing, processing, packing, release and holding ensuring medicinal products are consistently produced and controlled. The University of Birmingham has a GMP facility: the Medicines Manufacturing Facility (MMF) that  includes the Cell Therapy Suite (CTS), the Microbiome Treatment Centre (MTC) and the Healthcare Technologies Institute (HTI).