Question 1

Why is it important I follow the QMS?

Accepted Answer

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.

Question 2

How do I find the documents that I need?

Accepted Answer

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

Step 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.
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").

How it Helps: the code helps you locate and understand the document’s focus area within the QMS.

Step 2: Understand the Overall QMS Structure

The QMS is divided into six broad categories:

Governance Infrastructure: research governance and compliance policies.
Study/Trial Management: procedures for setting up and managing clinical research projects
Participant Safety: requirements for ensuring participant safety.
Data Integrity: standards for data management and accuracy.
Intervention: documents related to interventions and medical oversight in research.
Clinical Research in the Laboratory: procedures for setting up and managing a laboratory.

Step 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.

Step 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.

Step 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 then follow the four step listed below.

Navigate to the Participant Safety category.
Review any relevant QCDs for documentation and quality checks
Access the SOP that outlines the reporting process.
Select the adverse event reporting subsection.

Step 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.

Step 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.

Question 3

What is the difference between a Policy, SOP and QCD?

Accepted Answer

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 UoB Clinical Research Quality Manual (UoB-CQM-POL-001) (Word - 407 KB) 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.

Question 4

How do I know if a QMS document is applicable to my research project?

Accepted Answer

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

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

Question 5

When should I start using the QMS?

Accepted Answer

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.

Question 6

How can I best ensure that I comply with all the requirements in a SOP?

Accepted Answer

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 can track that your project meets all the required standards and compliance measures.

Step 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.

Step 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.

Step 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.

Step 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.

Question 7

How do I ensure I have the latest version of a QMS document?

Accepted Answer

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.

Step 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.

Step 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.

Step 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.

Step 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.

Question 8

Why is it important that I regularly check the QMS?

Accepted Answer

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.

Question 9

How can I quickly determine the important changes made since the last QMS document?

Accepted Answer

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.

Question 10

What should I do if I notice conflicting statements in QMS documents?

Accepted Answer

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

Step 1: 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.

Step 2: 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.

Step 3: 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.

e-Pathway: Maximising Impact

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