Applying for University of Birmingham Sponsorship

CTIMPs are subject to substantial oversight, and must be run in accordance with the University's Quality Management System (QMS). Information on the QMS and the University's Standard Operating Procedures for the management of clinical trials can be found on our QMS page. In particular, it may be helpful to refer to the UoB clinical research project setup SOP (Word - 347KB).

Please note that all CTIMPs Sponsored by UoB must be supported by a Clinical Trials Unit (CTU), and must use the IRAS Combined Review Service.

You will need to work with CTU colleagues to:

• Follow the Ethics processes to obtain an Ethics reference number.
• Set up an application via the Combined Review Service.
• Notify the Research Governance team that the application has been submitted via the CRS. At the time of writing, the CRS system does not send alerts to the RG team, so please be sure to notify the team when the application has been set up by emailing researchgovernance@contacts.bham.ac.uk.

It is not a requirement of Sponsorship that the supporting CTU must be a UoB CTU, though for obvious reasons this will often be the case for research based at UoB. Therefore while the Research Governance Team will of course be happy to discuss any aspect of CTIMP Sponsorship, in the first instance it may be most helpful to contact the CTUs directly via the following links:

• Birmingham Clinical Trials Unit (BCTU).
• Cancer Research Clinical Trials Unit (CRCTU).

Please note the Statement on use of University of Birmingham as a site in regulated clinical trials:

Please note that the University of Birmingham would not normally act as a ‘site’ for regulated clinical trials or surgery trials (i.e. Clinical Trials of Investigatory Medicinal Products (CTIMPs) or of medical devices). While exceptions to this may occasionally be made, where an exception is made this will be documented in writing in a letter from the University’s Research Governance and Ethics Manager. This means that no patients on CTIMPs, regulated device trials or surgery trials may be recruited, receive treatment or other interventions on University premises without the express written permission of the Research Governance Manager.

The University may provide services such as data or tissue analysis to trials based elsewhere. Please ensure that any such work is registered with the Research Governance team, even if UoB is not the formal Sponsor. Contact information is available on the Research Governance homepage.

1. Follow the Ethics processes to obtain an Ethics reference number.
2. Complete the IRAS form. For guidance on how to do so, see the online training course on making an IRAS application.
   
   The idea of IRAS is that you complete one set of data, which can then generate most of the forms that you need to complete. The 'HELP' link at the top of the IRAS form has useful resources if this is your first time through. Further guidance is available from Research Governance Team if required. See the Research Governance homepage for contact information.
   
   
3. Submit the IRAS form for Sponsor authorisation using the ‘Authorisations’ tab within the IRAS system. When asked for an email address, use researchgovernance@contacts.bham.ac.uk.
   
   NB: The application should be submitted for Sponsor authorisation, not transferred.
   
   
4. Send your complete Sponsorship application document set to researchgovernance@contacts.bham.ac.uk. See below for further information on the documents which you will need to include.

Please note that for Clinical Trials, University of Birmingham Sponsorship is conditional on trials being run according to the University's Quality Management System (QMS). Information on the QMS and the University's Standard Operating Procedures for the management of clinical trials can be found on our QMS page. In particular, it may be helpful to refer to the UoB clinical research project setup SOP (Word - 347KB).

Please also note the Statement on use of University of Birmingham as a site in regulated clinical trials (PDF - 62KB).

Please note that the University of Birmingham would not normally act as a ‘site’ for regulated clinical trials or surgery trials (i.e. Clinical Trials of Investigatory Medicinal Products (CTIMPs) or of medical devices). While exceptions to this may occasionally be made, where an exception is made this will be documented in writing in a letter from the University’s Research Governance and Ethics Manager. This means that no patients on CTIMPs, regulated device trials or surgery trials may be recruited, receive treatment or other interventions on University premises without the express written permission of the Research Governance Manager.

The University may provide services such as data or tissue analysis to trials based elsewhere. Please ensure that any such work is registered with the Research Governance team, even if UoB is not the formal Sponsor. Contact information is available on the Research Governance homepage.

• A copy of the research protocol in a MS Word-editable format, e.g. .doc.
• A patient/participant information sheet in a MS Word-editable format, e.g. .doc.
  
  
  • There may be several such documents, depending on the nature of the study. For example, there could be one for staff and another for patients.
  • Please consider the target audience of any relevant information, especially where participants may have conditions or characteristics which could affect their ability to interpret the information provided. Every effort should be made to enable participants to consent in an appropriate way.
  • Please also bear in mind the HRA's Make It Public strategy, designed to foster best practice and to help researchers be transparent about their work. This is especially important when creating Participant Information Sheets and Informed Consent Forms. Further information on the strategy is available on the Make it public webpage.
    
    
• A consent form (or forms, if applicable) in a MS Word-editable format, e.g. .doc.
• A signed and dated up to date CV for the Chief Investigator
• An up to date (i.e. < 3 years old) certificate of Good Clinical Practice for the Chief Investigator.
• If the Chief Investigator is a member of UoB staff, a completed CI declaration form.
• For external Chief Investigators (which usually also includes new studies where the CI has an honorary contract with UoB), either a completed external CI agreement, or confirmation that an agreement is in process with the Contracts team.*
• The risk assessment.
• If the study will involve one or more NHS sites and/or the use of NHS resources:
  
  
  • An mNCA, if available (or if not available, confirmation that an mNCA is in progress with the Contracts team). For more information please see the IRAS mNCA guidance.†
  • A Schedule of Events (SoE or SoECAT). A template document and guidance on how to complete it are available online.
    
    
• If the study will involve the collection of human tissue/Relevant Materials (for more information, see the HTA list of Relevant Materials), we will need to see evidence of the Chief Investigator having training in the Human Tissue Act, in the form of the Medical Research Council HTA e-learning.
  
  
  • As well as the requirement for evidence of the CI’s training in the HTA, all researchers involved in using human tissue must be aware of and adhere to the Human Tissue Authority's Code of Practice (PDF - 1.3MB).

Please note that ‘wet’ signatures are usually required, and we would request that relevant documents are printed, signed by hand and scanned where possible. But if this is not possible, for example because of lack of safe access to a scanner owing to pandemic restrictions, exceptions for typed signatures can be made. In such cases, please provide verification in the form of an email from the relevant individual’s institutional email account (i.e. UoB or equivalent, not gmail or similar), with the documents attached, confirming that the documents are genuine.

*For further information please contact the research support team in your College.

†Please note that mNCAs must be processed via the research support team in your College, and that the Research Governance team are unable to sign these off.

• A copy of the research protocol in a MS Word-editable format.
  A UoB protocol template for non-CTIMPs and a guidance document on how to complete it are available from our QMS page.
  
  
• A patient/participant information sheet in a MS Word-editable format, e.g. .doc.
  
  
  • There may be several such documents, depending on the nature of the study. For example, there could be one for staff and another for patients.
  • Please consider the target audience of any relevant information, especially where participants may have conditions or characteristics which could affect their ability to interpret the information provided. Every effort should be made to enable participants to consent in an appropriate way.
  • Please also bear in mind the HRA's Make It Public strategy, designed to foster best practice and to help researchers be transparent about their work. This is especially important when creating Participant Information Sheets and Informed Consent Forms. Further information on the strategy is available on the Make it public webpage.
    
    
• A consent form (or forms, if applicable) in a MS Word-editable format, e.g. .doc.
• A signed and dated up to date CV for the Chief Investigator
• An up to date (i.e. < 3 years old) certificate of Good Clinical Practice for the Chief Investigator.
• If a student is part of the project, a signed and dated up to date CV and a certificate of Good Clinical Practice for the student.
• If the Chief Investigator is a UoB member of staff or a UoB student, a completed CI declaration form.
• For external Chief Investigators (which usually also includes new studies where the CI has an honorary contract with UoB), either a completed external CI agreement, or confirmation that an agreement is in process with the Contracts team.*
• For Randomised Controlled Trials or High Intervention studies, a risk assessment may be required. This will not be required for validation, but can be discussed with the reviewer during the course of the review.
• If the study will involve one or more NHS sites and/or the use of NHS resources:
  
  
  • A Schedule of Events (SoE or SoECAT). A Schedule of Events (SoE or SoECAT). A template document and guidance on how to complete it are available online.
  • For studies falling into the first 4 IRAS categories: an mNCA, if available (or if not available, confirmation that an mNCA is in progress with the Contracts team). For more information please see the IRAS mNCA guidance.†
  • For any other studies: an Organisation Information Document. A template document and guidance on how to complete it are available online.
    
    
• If the study will involve the collection of human tissue/Relevant Materials (for more information, see the HTA list of Relevant Materials), we will need to see evidence of the Chief Investigator having training in the Human Tissue Act, in the form of the Medical Research Council HTA e-learning.
  
  As well as the requirement for evidence of the CI’s training in the HTA, all researchers involved in using human tissue must be aware of and adhere to the Human Tissue Authority's Code of Practice (PDF - 1.3MB).

Please note that ‘wet’ signatures are usually required, and we would request that relevant documents are printed, signed by hand and scanned where possible. But if this is not possible, for example because of lack of safe access to a scanner owing to pandemic restrictions, exceptions for typed signatures can be made. In such cases, please provide verification in the form of an email from the relevant individual’s institutional email account (i.e. UoB or equivalent, not gmail or similar), with the documents attached, confirming that the documents are genuine.

*For further information please contact the research support team in your College.

†Please note that mNCAs must be processed via the research support team in your College, and that the Research Governance team are unable to sign these off.

• A copy of the research protocol in a MS Word-editable format.
  A UoB protocol template for non-CTIMPs and a guidance document on how to complete it are available from our QMS page.
  
  
• A patient/participant information sheet in a MS Word-editable format, e.g. .doc.
  
  
  • There may be several such documents, depending on the nature of the study. For example, there could be one for staff and another for patients.
  • Please consider the target audience of any relevant information, especially where participants may have conditions or characteristics which could affect their ability to interpret the information provided. Every effort should be made to enable participants to consent in an appropriate way.
  • Please also bear in mind the HRA's Make It Public strategy, designed to foster best practice and to help researchers be transparent about their work. This is especially important when creating Participant Information Sheets and Informed Consent Forms. Further information on the strategy is available on the Make it public webpage.
    
    
• A consent form (or forms, if applicable) in a MS Word-editable format, e.g. .doc.
• Any other participant-facing documents.
• A signed and dated up to date CV for the Chief Investigator (CI).
• If a student is part of the project, a signed and dated up to date CV for the student and the supervisor (if not already covered as CI).
• A certificate of Good Clinical Practice for the CI (and possibly any students involved) will be requested by the reviewer during the course of the review if one is required, depending on the nature of the study. But if one is available, it may save time later on to send it with the other documents.
• If the Chief Investigator is a UoB member of staff or a UoB student, a completed CI declaration form.
• For external Chief Investigators (which usually also includes new studies where the CI has an honorary contract with UoB), either a completed external CI agreement, or confirmation that an agreement is in process with the Contracts team.*
• If the study will involve one or more NHS sites and/or the use of NHS resources, we will also need an Organisation Information Document and a Schedule of Events. Templates for both of these documents and guidance on how to complete them are available online.

Please note that ‘wet’ signatures are usually required, and we would request that relevant documents are printed, signed by hand and scanned where possible. But if this is not possible, for example because of lack of safe access to a scanner owing to pandemic restrictions, exceptions for typed signatures can be made. In such cases, please provide verification in the form of an email from the relevant individual’s institutional email account (i.e. UoB or equivalent, not gmail or similar), with the documents attached, confirming that the documents are genuine.

*For further information please contact the research support team in your College.

Studies involving NHS staff as the only participants take a slightly different approval route from the study types in the above sections.

The documents required for review are the same as those required for studies involving patients. Please see the sections above for details of the documents required.

However unlike the majority of studies covered in the above sections, studies involving only NHS staff do not usually require NHS REC approval. Instead these applications undergo a joint UoB Ethics and Research Governance review and receive approval from a UoB REC. Following UoB REC approval the application is passed to the Research Governance Team for Sponsor review, and when Sponsorship has been approved the application is submitted for HRA approval through IRAS.

In the first instance, please engage with the University of Birmingham Ethics system to begin your application.

Ethics team members will then liaise with the Research Governance team in a collaborative review process. In most cases, you will initially receive feedback from the Ethics team which will also include the review comments from the Research Governance team.

Once you have received ethics approval, the study will undergo a final Research Governance review prior to Sponsor approval and subsequent submission to the HRA.