sop for uhs sponsorship of research studies

R&D Department

Do not make unauthorised copies of 16

R&D/Gen/Admin/012

Standard Operating Procedure for the Review and Approval of UHS Sponsorship of Research Studies.

Standard Operating Procedure for the Review and Approval of UHS Sponsorship of Research

Studies.

SOP Number: R&D/Gen/Admin/012

Version Number & Date:

Version 2, October 2019

Superseded Version Number & Date:

Version 1, June 2012

Author: Sharon Davies-Dear Designation: Clinical Trial Project Manager

Authorised by: Dr Mikayala King Designation: R&D QA Manager

Expert authorisation: Joanna Cantle Designation: Head of Clinical Trials

Pharmacy

Version Number Effective Date Reason for Change (incl. names/designations author and authorisation)

v2 October 2019 Revision of sponsor request process to clarify when UHS will act as Sponsor and to include process for Study assessment. Amended responsible roles for stages of Sponsor Request.

v1 June 2012 First version, written by Mikayala King, Research Governance and QA Manager and authorised by Ailsa Duckworth, Head of R&D

NB: Reviews of this SOP where no change is warranted will be recorded in QPulse.

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1. BACKGROUND The role of the Research Sponsor under the UK Policy Framework for Health and Social Care Research and the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI2004/1031) must be assigned to every project. The Sponsor is an organisation willing and able to take over all legal responsibility for the study and takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study. The decision whether to act as sponsor for a research study is based on several categories of risk, including those to the potential participants, the study data and the Trust. Studies are also peer reviewed to determine scientific robustness and value of the research question. The NIHR Research Support service initiated a risk assessment tool in 2010 to assist Trusts in making the decision as to whether to act as Sponsor. The NIHR RSS risk assessment categories provide a way to assess and proportionately manage sponsorship risks when the Trust is deciding to act as the sponsoring organisation. These categories also support investigators to consider risk and assist with risk mitigation decisions.

2. PURPOSE

The purpose of this SOP is to describe the procedures which the UHS R&D Office uses in order to give a sponsorship decision to the Chief Investigator on behalf of the organisation for clinical research studies. The Trust may delegate some Sponsor responsibilities to other organisations (e.g. Clinical Trials Unit or Clinical Research Organisation) or individuals (e.g. Chief Investigator) and it is expected that in making a Sponsorship decision for the organisation all Sponsor responsibilities have been clearly documented and attributed.

3. SCOPE

This SOP relates to the R&D procedure for review and approval of Sponsorship requests for research studies by UHS. This SOP applies to all studies where a Sponsorship decision has to be made on behalf of the Trust and includes both NIHR portfolio and non-portfolio studies. This SOP does not include the process for sponsorship in principle for Grant proposals. This process is included in the SOP for the review and administration of Grant proposals (R&D/Gen/Admin/035) All SOPs must be used in conjunction with all relevant Trust policies and procedures

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4. RESPONSIBILITIES

Chief Investigator (CI) Responsible for:

Requesting sponsorship and submitting the documents required by R&D in order for them to make a decision on sponsorship of a study.

Working with R&D to mitigate and manage any risks identified with the study.

Carrying out the tasks delegated to them by the sponsor as detailed in the Chief Investigator agreement.

Divisional Research Manager (DRM)

Responsible for:

Assessing sponsorship applications for relevant Division using the study assessment provided by the CI to inform the R&D Sponsorship Study Risk Assessment..

Ensure that the study fits the criteria for UHS sponsorship.

If identified as a possible CTIMP, ATIMP, Device, Multisite or Interventional study, discussion with the CTPM for risk review.

Liaison with the CTPM to identify any risks associated with sponsorship of the study and liaising with Chief Investigator and study team to manage and mitigate any identified risks

Escalation of risks to R&D Manager in the first instance if study risks remain high following review of CI study assessment.

Requesting letter of Sponsorship in Principle/Full Sponsorship by Research Administrator and signature of the letter.

Clinical Trials Project Manager

Responsible for:

Assisting the DRM in assessing sponsorship applications for CTIMP, ATIMP, Device, Multisite and Interventional studies using the risk assessment provided by the CI to inform the R&D Sponsorship Study Risk Assessment.

Assisting the DRM to ensure that all risks associated with the study are identified and have mitigation plans in place.

Liaising with study team and DRM to manage and mitigate any identified risks

Escalation of risks to the DRM in the first instance if study risks remain high following review of CI Study Assessment.

In the absence of the Research Administrator, monitor the [email protected] account.

In the absence of the Research Administrator creating the DEV number and adding the study to EDGE.

In the absence of the Research Administrator distributing the sponsorship requests to the appropriate DRM.

mailto:[email protected]

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In the absence of the Research Administrator creating the RHM number and issuing the Sponsorship in Principle letter.

In the absence of the Research Administrator issuing the Sponsorship in Full email.

R&D Manager (RDM) Responsible for:

Acting as an escalation point for risk concerns.

Referring studies to an appropriate sponsorship committee for further escalation where appropriate.

Research Facilitators (RF)

Responsible for: -

Highlighting to DRM/CTPM if there is any issues identified during feasibility which have occurred since original risk assessment (i.e. equipment added to study, change in study design).

Assisting with implementing and mitigation of risks identified as required.

Research Administrator (RA)

Responsible for:-

Daily monitoring of the [email protected] account to distribute sponsor requests to appropriate DRM and provide sponsor request pack as required.

Ensuring all sponsorship application packs are complete when registering the study on EDGE and creating the Development number (i.e. DEV DVA0001) at the point of Sponsorship request being received.

Generating RHM number before issuing Sponsorship in Principle letter.

Issuing Sponsorship in Principle letter for DRM signature.

Issuing Full sponsorship email once confirmed and ensuring the CI Agreement has been completed and signed.

Responsible for informing the University of Southampton of their involvement in the study.

Liaising with the study teams where necessary and when requested by the DRM/CTPM.

All Staff Must ensure that they have read and understood appropriate SOPs and any revised versions prior to undertaking a procedure to which the SOP pertains. Should alert the R&D QAM or the author of SOPs that require changing or archiving. All staff may be asked by a manager to complete tasks in this SOP not directly attributed to their job role.


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5. PROCEDURE

5.1. Conditions of Sponsorship:

A research sponsor is responsible for ensuring that any research project or clinical trial complies with the appropriate legislation and Good Clinical Practice. For this reason, where there is no third party sponsor, University Hospital Southampton NHS Foundation Trust (UHS) may act as sponsor, subject to the conditions below and the receipt and evaluation of a UHS Sponsorship Application and Study Assessment Form, for research where:

5.1.1 The study has an experienced Chief Investigator or if an inexperienced Chief

Investigator they are willing to be mentored by an experienced UHS (or UoS)

Chief Investigator/carry out CI training

5.1.2 CI is based in Southampton and is a substantive employee of UHS NHS FT

or holds an honorary clinical contract with UHS NHS FT and is a substantive

employee of University of Southampton.

5.1.3 The study is due to be performed in an acute hospital setting and UHS NHS

FT is a planned recruitment site.

5.1.4 The study is a student project where the lead investigator is an employee

and/or student of University of Southampton and UHS is a planned

recruitment site.

N.B. Supervisors on student projects will need to meet the requirements of substantive

employment/honorary contract with UHS NHS FT detailed above.

5.1.5 CI has demonstrated the ability and resources to support the research,

including, but not limited to, that trial management arrangements have been

considered.

N.B. Trial management and sponsor oversight may be in the form of a Clinical Trials Unit

(CTU)/Clinical Research Organisation (CRO) / trial management team funded in the

study budget as appropriate.

5.1.6 UHS can appropriately indemnify the activities under the NHS Litigation

Authority Indemnity Scheme.

N.B. Sponsor would need to determine in collaboration with the CI if appropriate

insurance cover can be arranged and any additional costs for such insurance cover are

covered by the study funding.

5.1.7 The study has received the appropriate peer review assessed by risk to

confirm the scientific robustness and clinical safety of the study. This may be

as part of a grant funding application or using the UHS Peer Review form

(R&D/Forms028).

5.1.8 The study has appropriate funding levels for the resources required to

conduct the study.

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N.B. The Trust does not routinely sponsor internationally or enter into co-sponsorship

arrangements.

5.2. CTIMP, ATIMP, Device, Multisite and Interventional studies

Applications for CTIMP, ATIMP, Device, Multisite and interventional studies must have a risk assessment performed by the CTPM.

The Chief Investigator must make contact with the Pharmacy department prior to application for sponsorship for CTIMP studies. This is also the case for ATIMP studies but this process will be coordinated through the ATIMP committee. See Appendix 1 for Sponsor oversight of IMP management, delegated to the UHS clinical trials pharmacy, when UHS is Sponsor and the research is NOT managed by the SCTU. Where the research is being managed by the SCTU then all IMP management duties are delegated to the CTU and UHS Pharmacy will carry out site duties only.

The Chief Investigator must make contact with the Medical Equipment Management Service (MEMS) and refer to the Medical Devices & Equipment Management and Training Policy prior to application for sponsorship for device studies.

NB: This contact should be documented when submitting the UHS Sponsorship Application and Study Assessment Form at the point of sponsorship application.

5.3. Special Category Studies

Some studies may require further assessment for example:

Advanced therapy studies (ATIMPs).

Novel molecules or novel molecules in new combinations.

Large multisite UK based studies (where there is no CTU or CRO involved in the management of the study).

International studies.

Unusual study design which may introduce additional risk either to patients, staff or Trust as Sponsor.

Where this is the case these studies will be escalated to the RDM in the first instance but may need further assessment by an appropriate committee, such as the ATIMP committee or the early phase safety committee, or further escalation.

5.4. Non-Sponsorship

In some cases UHS NHS FT is unable to act as Sponsor for a study if it is not possible to mitigate risks following the UHS Sponsorship Application and Study Assessment Form submission and review. For example:

The study has a Chief Investigator who is not an employee of UHS or does not hold an honorary contract.

The study is due to be delivered in primary care and there is no link to UHS.

UHS NHS FT is not a planned recruiting site of the study and UHS does not hold the funding.

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The study has an inexperienced Chief Investigator who is not willing to have mentoring support or appropriate training.

No consideration or arrangements can been made in relation to the day to day trial management of the study in the form of a CTU/CRO/trial management team.

UHS cannot appropriately indemnify the project under NHS Litigation Authority Indemnity Scheme (or alternative insurance costs cannot be covered).

If the study does not have sufficient funding or cannot secure additional funding in order to cover the costs of running the study.

5.5. Sponsor Request Process:

In order to apply for UHS Sponsorship, the Chief Investigator should contact R&D via the [email protected] account which will be monitored by the RA.

The RA will then provide the Sponsorship Request Pack for completion by the CI and study team. This will include:

Guideline on completion of the UHS Sponsorship Application and Study Assessment Form (R&D/Gen/Admin/G29)

UHS Sponsor Request and Study Assessment Form (R&D/Forms020)

UHS Peer Review Form (R&D/Forms028)

Appropriate HRA Protocol Template (https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/)

The researcher must then send the following to the [email protected] account:

Completed UHS Sponsorship Application and Study Assessment Form

Current version of the study protocol

Two completed UHS Peer Reviews

Confirmation if changes requested in the peer reviews have been taken into account in the protocol

Funding award letter

NB. Internal Scientific Peer Review is only required when this has not been carried out as part of an application for funding.

The RA will create a new entry on EDGE and generate a unique ID for the study (see SOP EDGE for R&D Office (R&D/Gen/Admin/003)). For studies registered in R&D in this way the study will be marked as being in ‘Development’. UHS as sponsor will be indicated in the EDGE system.

The RA will determine at this stage if there is University of Southampton involvement and mark this on EDGE. The UHS Sponsorship Application and Study Assessment Form includes a box that requires the researcher to indicate the principal employer of CI which is the determining criterion.

RA will save all Sponsor application documents in study specific folder on the R&D drive Z:\TrustHQ\Governance\RESEARCH\R&D Dept\Studies\00 - UHS Sponsor Request, then the appropriate Division and Unique ID and in folder UHS Sponsor Oversight, Sponsor Request. The RA will distribute the sponsorship requests to the relevant DRM as they are received into the [email protected] account.

https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/

https://www.hra.nhs.uk/planning-and-improving-research/research-planning/protocol/



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NB: For investigators who have received a grant but have not completed the Grant proposal review process (R&D/Gen/Admin/035), the CI should contact the [email protected] account in order for the RA to provide the Sponsorship Request Pack for completion. If the researcher has completed the Grant proposal review process then the RA will have sent the sponsorship request pack upon UHS agreeing to be named as sponsor on the application.

Once received by R&D, this information will be reviewed using the Guideline on managing sponsorship risk and mitigation (R&D/Gen/Admin/G30), UHS Sponsorship Application and Study Assessment Form (R&D/Forms020) and Protocol Review Checklist (R&D/T&C/0021).

If the study is an IMP study (including ATIMPs) CTPM must contact pharmacy to inform them that the sponsorship request has been received and is being reviewed. If the study is a Device study then the DRM/CTPM must contact MEMS to inform them that the

sponsorship request has been received and is being reviewed.

The DRM/CTPM will also refer to the peer review form and ensure any concerns raised have been addressed in the protocol and that the reviewer is satisfied with the scientific worth of the study.

If funding has been awarded to the study via a grant awarded to UHS the DRM will ensure that the study has been costed appropriately by the Grants Accountant and the awarded funds match the original costing template.

The DRM in conjunction with the CTPM (if applicable) will determine at this stage whether UHS will offer Sponsorship in Principle or if further work with the CI is required to mitigate risks. Any queries should be escalated to the RDM.

5.6. Incomplete Sponsorship in Principle review

If not possible to issue ‘UHS R&D sponsorship in principle’ the DRM will e-mail the CI informing them of the reason for refusal and offering a meeting to discuss any queries or clarification for risk mitigation. Following a meeting with the CI and any support departments as applicable, the DRM/CTPM will review the UHS Sponsorship Application and Study Assessment Form (R&D/Forms020). If appropriate mitigation has been identified, Sponsorship in Principle will be issued (see 5.7). If there is risk which cannot be mitigated following the meeting, the Sponsorship Request will be escalated to the RDM for further review and escalation as appropriate. CI will be informed by DRM that the issues are being escalated.

5.7. Completed Sponsorship in Principle review

If all the conditions have been met the DRM/CTPM will request the CI meets to read and sign the CI Agreement (R&D/Forms019). Once arranged, a copy of this and the Sponsor Request sign off sheet (R&D/Forms021) will be provided to the Research Administrator to generate an RHM and to request a Sponsorship in Principle Letter (Appendix 2) is generated for signature. A copy of the completed Sponsor Request sign off sheet should be signed and converted to PDF and

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saved in the electronic folder i.e. Z:\TrustHQ\Governance\RESEARCH\R&D Dept\Studies\00 - UHS Sponsor Request\Division B\DEV DVB0002\9 UHS Sponsor Oversight\Sponsorship Request

The RA will send an email together with a copy of the letter to the CI, using template Appendix 4. This should include the following details to be added to the IRAS Form

Question A4 Who is the contact on behalf of sponsor for all correspondence relating to application for this study – This may be the Sponsor i.e. DRM or CTPM, A Project Manager, Trial manager, CRO.

Question A64 Lead Sponsor – This should either be the details of the DRM or the CTPM, dependent on the project type.

Question A68 Give details of the lead NHS R&D contact for this research – This should be the UHS facilitator or RC.

If the study has been identified as having UoS involvement the RA will include copies of the current University of Southampton insurance forms with the Sponsorship in Principle Letter. These letters give provisional University of Southampton insurance approval, which is necessary for the ethics submission. Final University of Southampton insurance approval is applied for using the University ERGO registration system.

5.8. Full Sponsorship

If the study is to be managed by a CTU or CRO and a risk assessment is carried out at that unit, this will need to be provided for review by the CTPM (and DRM if appropriate) prior to full sponsorship being agreed. Where UHS has agreed in principle to take on the role as Sponsor the CI will be required to transfer the completed IRAS form and documents to be submitted to the CTPM/DRM or RF for review and comment. Once all comments have been addressed the CI will request authorisation through the IRAS system.

NB: The IRAS declaration section must not be signed until a sponsorship in principle letter has been issued to the CI and the CTPM/DRM or RF has checked that the application reflects what was agreed.

The CTPM/DRM or RF will request from the RA that the confirmation of full sponsorship (Appendix 3) is sent to the CI once the IRAS authorisation is given. NB: The intention is that the initial risk assessment should have identified any key issues and it is highly unlikely full sponsorship will not be given unless all potential issues cannot be mitigated or were not identified at sponsor application stage.

5.9. Full Risk Assessment

If the study is to be managed by a CTU or CRO and a risk assessment is carried out at that unit, this can be used in lieu of an R&D prepared risk assessment. For studies awaiting regulatory outcome and following the Sponsorship in full agreement, a full risk assessment may be required. This full risk assessment will inform sponsorship

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oversight (including monitoring), and risk mitigation activities. This is the case for any study which meets the following criteria:-

Involves a Clinical Trial Investigational Medicinal Product (CTIMP) or Advanced Therapy Investigational Medicinal Product (ATIMP)

Involves a medical device

Is a multisite study

Is classified as interventional

Is classified as a medium or high risk from initial assessment. For studies requiring a full risk assessment, the CTPM will contact the study team to request a meeting to discuss the full assessment. NB: Please note elements from the UHS Sponsor Application and Study Assessment Form will be considered during this risk assessment. Any risk assessment completed as a consequence of for example, the study being carried out in the Clinical Research Facility or involvement from the Early Phase Safety Committee, can be used by the CTPM to prepare the R&D assessment. CTPM should use the Risk Assessment Form (R&D/Forms029) and Guideline on managing sponsorship risk and mitigation (R&D/Gen/Admin/G30) to create this risk assessment for discussion with the study team and CI. N.B. If the study involves pharmacy or medical devices, the risk assessment should have input from the support teams before finalising. Any risk assessments carried out by these teams can be incorporated into the R&D assessment. The risk assessment will be provided for CI input and the suggested mitigations will need to be agreed and disseminated to the study team by the CI. This dissemination will need to be documented in the Trial Master File for the study.

For studies which are assessed as Low or Medium risk, once this is signed off a copy will be sent to the CI. If the study is assessed as High risk, further mitigations will need to be considered and will be escalated to RDM as necessary to recommend further action or escalation.

6. REFERENCES

ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996), Principle 2.13. Medicines for Human Use (Clinical Trials) Regulations 2004/1031, Schedule 2, part 1, principle 13. Research Support Services Framework - Streamlining the management and governance of R&D studies in the NHS. NIHR 2011. Sponsorship Principles. NHS R&D Forum V2: December 2012 UK Policy Framework for Health and Social Care Research 2017

7. Related Documents

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UHS Sponsorship Application Form and Study Assessment (R&D/Forms020)

UHS Peer Review Form (R&D/Forms028)

Guideline on completion of the Study Assessment and Sponsorship Application (R&D/Gen/Admin/G29)

Guideline on managing sponsorship risk and mitigation ( R&D/Gen/Admin/G30),

Protocol Review Checklist (R&D/T&C/0021)

Sponsor Request sign off sheet (R&D/Forms021)

CI Agreement (R&D/Forms019)

Sponsorship Full Risk Assessment Form (R&D/Forms029)

Copy control log

Title: Standard Operating Procedure for the Review and Approval of UHS Sponsorship of Research Studies

Version: 2.0, December 2018

Master/Copy Location Authorised by

Authorised to

Authorised Date

Master e- version (PDF)

Q-Pulse document management system

Head of R&D R&D Department

Master e- version (Word)

Z:\TrustHQ\Governance\RESEARCH\R&D Dept\Policies&SOPs\SOPs\Current Approved R&D SOPs

Head of R&D R&D Senior Managers

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Appendix 1 Responsibilities for IMP management require documenting for the following activities- 1. Identification prior to grant application stage that a proposed idea will involve an IMP and

UHS is likely to be sponsor to ensure feasibility and sourcing of IMP 2. Where IMP required contract manufacture an assessment of GMP will be required,

Phase 1 studies definitely require audit of manufacturer. 3. Identify manufacturer with (MIA) IMP licence suitable to undertake manufacture of IMP. 4. Receive written quotes. 5. Draw up Product Specification File (PSF) / IMPD 6. Devise label to go in CTA application 7. Agree Technical agreement for contract manufacturer for IMP studies. R+D authorised

signatories in conjunction with pharmacy. 8. Agree QP release details (technical release) 9. Agree sponsor release process 10. Arrangements for site ordering of IMP 11. Monitoring of IMP during transit – temperature excursions 12. Monitoring of IMP whilst at site – temperature excursions 13. Date extension – process and responsibilities 14. Recall procedure – process and responsibilities 15. Destruction procedure- process and responsibilities 16. Accountability at site – suitability of logs/authorisation/ checking of suitability of other logs 17. Randomisation- process and responsibilities

18. Unblinding- process and responsibilities. Must be tested. SOP’s detailing actual processes will be owned and maintained by the pharmacy department.

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Appendix 2 - Letter template – Sponsorship in Principle R&D Department

Level E, Laboratory & Pathology Block <insert postal address> Mailpoint 138

Southampton General Hospital Southampton

SO16 6YD

[email protected]

Tel: +44(0)23 8120 xxxx

<Date>

Dear (insert CI name)

RHM xxxxxxx - (Input Study Title)

Re: Sponsorship in Principle - NHS Research Governance and Identification of Nominated Research Sponsor

I am writing to confirm that University Hospital Southampton NHS Foundation Trust is prepared to act, in principle, as Sponsor for this study under the terms of the Department of Health UK Policy Framework for Health and Social Care Research.

UHS's final acceptance of sponsorship responsibilities is dependent on full R&D review and risk assessment and will be indicated byemail and signature on the completed IRAS submission. We advise you to seek early R&D guidance on the submission of relevant NHS access permissions (Research Passport Form/Letter of Access/Honorary Contracts).

UHS fulfills the role of research sponsor in ensuring management, monitoring and reporting arrangements for research. I understand that you will be acting as the Chief investigator responsible for the daily management for this study, and that you will be providing regular reports on the progress of the study to the Trust on this basis.

I would like to take this opportunity to remind you of your responsibilities under the terms of the UK Policy Framework for Health and Social Care Research, that it is a requirement of the terms and conditions of sponsorship approval that you become fully conversant with the UK Policy Framework for Health and Social Care research document which is available from : https://www.hra.nhs.uk/planning-andimproving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research.

Please be aware that UHS have the right to put on hold or revoke sponsorship at any point of the study if responsibilities under the terms of the UK Policy Framework for Health and Social Care Research are not adhered to.

You should also note that the study should not start, prior to regulatory approvals and R&D confirmation of capacity & capability being place.

Please do not hesitate to contact R&D should you require any additional information or support. We look forward to working with you on your project.

Yours sincerely,

Divisional Research Manager – Division X


http://www.hra.nhs.uk/planning-and

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Appendix 3 - Email template – Full Sponsorship

To: CI

CC: Study team, DRM and CTPM, RF

Subject: Full Sponsorship RHM xxxxxxx

Dear CI

RHM xxxxxxx - (Input Study Title)

Re: Fully Sponsorship - NHS Research Governance and Identification of Nominated Research Sponsor

I am writing to confirm that University Hospital Southampton NHS Foundation Trust is prepared to act, in full, as Sponsor for this study under the terms of the Department of Health UK Policy Framework for Health and Social Care Research.

UHS fulfills the role of research sponsor in ensuring management, monitoring and reporting arrangements for research. I understand that you will be acting as the chief investigator responsible for the daily management for this study, and that you will be providing regular reports on the progress of the study to the Trust on this basis.

I would like to take this opportunity to remind you of your responsibilities under the terms of the UK Policy Framework for Health and Social Care Research, that it is a requirement of the terms and conditions of approval that you become fully conversant with the UK Policy Framework for Health and Social Care research document which is available from : https://www.hra.nhs.uk/planning-andimproving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research.

Please be aware that even though full UHS sponsorship has been given, UHS still have the right to put on hold or revoke sponsorship at any point of the study if responsibilities under the terms of the UK Policy Framework for Health and Social Care Research are not adhered to.

You should also note that the study should not start, prior to regulatory approvals and R&D confirmation of capacity & capability being place.

Please do not hesitate to contact R&D should you require any additional information or support.

We would like to take this opportunity to wish you well with your study.

Kind regards

Divisional Research Manager – Division X

http://www.hra.nhs.uk/planning-and

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Appendix 4 - Cover email template for sponsorship in principle letter

To: CI Copy: Any other study contacts, DRM, CTPM, RF Subject: RHM number – Short study title, Sponsorship in Principle Dear XXXXXX Subject: RHM number – Short study titile Further to your recent request for UHS to act as sponsor for the above study, please find attached letter confirming that UHS are prepared in principle to act as sponsor for the study. Please enter the following details in your IRAS application A4, A64, A68 Need to be tailored depending on the type of study (this instruction should be removed before sending the email) Question A4 – Who is the contact on behalf of sponsor for correspondence - This may be the DRM or CTPM, A Project or Trial Manager for the study or CRO details if there is one involved Question A64 – Lead Sponsor – This should either be the details of the DRM or the CTPM, this will depend on the type of study Question A68 – Give details of the lead NHS R&D contact for this research – This should be the UHS Facilitator or Research Coordinator. Please can the following be updated/confirmed prior to submission to the REC/HRA and MHRA (if applicable) for review and approval (This sentence may not need to be included if there are no points to address prior to submission and should be removed if not required. - - Once you have completed your IRAS form and supporting documentation, please request sponsor authorisation via IRAS and forward all your supporting documentation, i.e. all documents that you are submitting to the REC/HRA and MHRA (if applicable) for review and approval to (insert details of person to send documents too). Your IRAS form cannot be authorised until all the documentation has been received and reviewed and any amendments made where required. You should also note that the study should not start, prior to regulatory approvals and R&D confirmation of capacity & capability being in place. If we can be of any further assistance, please do not hesitate to contact us. Regards