Frequently Asked Questions (FAQs)

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, 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.

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). 

There are many different public register that can be used, including:

• ClinicalTrials.gov (free to register)
• ISRCTN registry (may incur a fee*)

* Non-commercial studies/trials with an interventional component included on the NIHR Clinical Research Network Portfolio quality for free ISRCTN registration, see the NIHR ISRCTN registration for more information.

The IRAS website provides an e-learning guide which has been developed by the Medical Research Council (MRC) Regulatory Support Centre and the Health Research Authority (HRA). This guide provides instructions on the use and completion of the IRAS form. The IRAS website also provides question-specific guidance for each question in the IRAS form.

The UoB Research Governance Team also have guidance on the completion and submission of IRAS forms on their web pages, and would be the best team to contact if you have a specific question regarding the IRAS form.

The University purchases Clinical Trials cover which provides automatic cover for all Clinical Trials including those where the University accepts responsibility as sponsor. Please note, the term Clinical Trials used here refers to all clinical research (studies and trials). There are some exclusions to the cover, which must be discussed with the UoB Research Governance Team before or during the sponsorship review

Please note, the Clinical Trials cover is renewed every year with a new certificate issued. A certificate for every year your clinical research project is active should be filed in the study/trial master file. See Clinical trials activities and Insurance Cover (PDF - 561 KB) for the latest certificate. If you required earlier evidence, please contact UoB Research Governance Team. 

For all staff and postgraduate research (PGR) student projects (including projects deemed to be service evaluation by the NHS) being conducted on behalf of the University, the Chief/Principle Investigator (CI/PI) or academic supervisor will need to submit an online self-assessment form (SAF). This will generate a unique Ethics Reference Number (ERN) for your project, and you will be instructed as to whether further ethical review is required. Please see UoB guidance on SAFs and how to submit one.

RGT stands for Research Governance Team (RGT): they manage sponsorship of clinical research projects at the University of Birmingham under the UK Policy Framework for Health and Social Care Research that sets out principles of good practice in the management of health and social care research in the UK. You will need to contact RGT to have your clinical research sponsored. In addition, the team also deals with the following research processes and should be contacted for queries regarding:

• Reporting - throughout the duration of the research, RGT will monitor the submission of annual reports to the REC and, if applicable, to the Competent Authority, such as the MHRA.
• Site agreement - responsible for set up of agreements with participating sites.
• Insurance - RGT ensures the research has appropriate insurance cover.

CRCT stands for Clinical Research Compliance Team (CRCT): In contrast, the CRCT helps to ensure clinical research projects and in particular clinical trials are conducted in line with any applicable regulations, international standards and University standards. The team develops and maintains the UoB Quality Management System (QMS) and provides support to researchers with document development. CRCT provides training and support to researchers to ensure clinical research projects are compliance with the applicable regulations and standards. CRCT is also responsible for compliance review across the clinical research portfolio to assess the projects’ compliance with the regulations and standards. CRCT runs two programmes: the Sponsor Support Visit (SSV) Programme and Audit Programme. See FAQ on ‘What is the difference between an SSV and an audit?’.

How does R&D fit in?

R&D stands for Research and Development. If your clinical research involves NHS premises or NHS participants (staff or patients), researchers will also need approval from the relevant NHS R&D Trust. Whilst the approval process is an automatic part of the Health Research Authority (HRA) approval completed via the Integrated Research Application System (IRAS), researchers are encouraged to liaise directly with the relevant Trust’s R&D department early on to ensure that they can facilitate the research.

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.

Clinical trials will need to document this in a trial-specific Risk Assessment (see Risk Assessment Template) which will be submitted as part of the initial sponsorship submission, for more information please see the UoB Trial Quality Management SOP. For clinical studies, a formal structured risk assessment is only necessary when identified as essential, however the risks should be documented and reviewed by the research ethics committee. For further guidance, please see the UK Policy Framework for Health and Social Care Research.

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 UoB Quality Management System (QMS)). 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 (Word - 122 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. 

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), GCP in the Laboratory 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.

You will need to provide evidence that you are appropriately qualified by education and experience to perform your tasks. This can be evidenced through a CV and/or job application form with proof of relevant education and experience and a signed Job Description which specifies the tasks assigned to the staff member. Please refer to the UoB Training SOP (Word - 170 KB) for further information.

Within a laboratory setting for clinical trials, it is important that analysts are competent to perform the analysis or evaluation of human biomaterial samples. Therefore, you also need to define ‘competency’ both in terms of what it means to be competent to perform an assay or to use a piece of equipment and what it means to be competent to train someone to perform an assay or to use a piece of equipment. Please refer to the UoB Laboratory Set Up and Management SOP (Word - 86 KB) for further information.

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 research data management seminar, delegation of duties training session or a workshop on conducting clinical research in a UoB laboratory. 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 and deliver of clinical research (e.g. Chief Investigator, Research Nurse, Trial Coordinator) are required to have completed the National Institute for Health Research (NIHR) GCP training which can be via an online course or face-to-face. 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 attending the NIHR GCP refresher courses every 3 years as per the UoB Clinical Trials 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 includes 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 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 Set-Up and Management (Word - 86 KB)
• 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. An 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. An 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 an 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.

When you come to the end of your clinical research project you may find that you have some left over human tissue samples which were not used up in your experiments/analysis. One obvious option for the residual samples is to dispose of them as described in the ethics application, using the appropriate waste disposal route. However, tissue samples are precious and may still be able to be of use scientifically, so there are a couple of other options.

1. You can apply for ethical approval from an NHS Research Ethics Committee (REC) to use these samples in another research project. The participants who donated these samples will need to have given their consent for their samples to be approved in future ethically approved research. However, the REC may still give approval for the use of samples where consent for future research was not asked of the participants, provided the samples are fully anonymised prior to use in the other research project. Please note, the ethics of the project the samples are moving under must at least be in the process of being approved before the ethical approval of the current project comes to an end.
2. Another option is to transfer the samples to a facility that holds a Human Tissue Licence (also called a licenced premises). The University of Birmingham has two licenced premises; the Human Biomaterials Resource Centre (HBRC) and the Birmingham Dental School Tooth Bank. For further information about using the HBRC please contact the HBRC via email and address the email for the attention of Gareth Bicknell. Please be aware that there is a fee to use these facilities.

If you are working with human tissue samples which contributes to the (primary, secondary and exploratory) endpoints of a Clinical Trials of Investigational Medicinal Products (CTIMPs), you are required to work to GCP in the Laboratory standard. 

If you are working with human tissue that is considered relevant material under the Human Tissue Act, and is part of a clinical study, you are required to work to the Human Tissue standard.

For further information on what it means to be working to either of these standards please see the Laboratory and Human Tissue section of the UoB Clinical Research QMS.

The CRCT deliver a training session several times a year focussing on these laboratory standards. One of the training sessions is called ‘Clinical Research in a UoB Laboratory’, which focusses on both GCP in the Laboratory and Human Tissue standards. Another training session called ‘Working with Human Biomaterial in a UoB laboratory’ focusses solely on the Human Tissue standard. To see when our next training session will be and to register please visit our Training and Workshop page.

If you are aware that you need to work to GCP in the Laboratory standard and require support with the set up process please contact us to find out more about our GCP in the Laboratory Set Up process.

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 two GMP facilities: the Cell Therapy Suite (CTS) and the Microbiome Treatment Centre (MTP).