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Registering a research project procedure

1 Aim

This procedure should be followed when an investigator or research team are completing set up activities as part of the formal capacity and capability assessment so that confirmation of capacity and capability (CC&C) can be issued.

Project registration is the first step in the research governance authorisation process, without which no study on trust premises, involving trust patients, staff or their data may begin. Project registration provides the investigator with access to support from the Grounded Research department in the stages involved in obtaining the approvals and agreements necessary for authorisation, ensuring that research governance requirements are met.

2 Scope

All staff internal or external to the trust who are involved in research

This procedure is always applicable when trust participation is requested for hosted research, for example, research not sponsored by Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH).

3 Link to overarching policy

This procedure is overarched by the research governance policy.

4 Procedure

4.1 Registration

The registration process requires the investigator to complete a Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) registration form and submit it to the Research Governance team in addition to the local information pack (LIP). (refer to appendix B). A registration form can be requested and by emailing the research governance inbox at rdash.research-gov@nhs.net.

  • The investigator or delegated member of his or her research team completes and sends the registration form via email to the research governance inbox.
  • The details required for registration are listed on the research registration form and the investigator is required to complete all fields relevant to the intended research project.
  • The registration form is intended to create an overview of the proposed research project to assist the Grounded Research Department in assessing its individual research governance requirements.
  • Submission of an incomplete registration form will result in a delay to the project registration process. Links to relevant guidance are provided in the registration form.
  • The investigator is advised to consider their project details carefully to avoid errors in project information.

Once a study has been registered, a research governance lead and a study delivery lead will be assigned to support the project through the set-up process.

The Health Research Authority (HRA) advise that the local information pack is submitted when the Health Research Authority initial assessment letter is issued. Further information about the local information pack can be accessed on the Health Research Authority website.

Where the study is Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) sponsored, it is expected that investigators will engage with Grounded Research at the point where they are developing a protocol and applying for funding. Refer to the research sponsorship procedure.

4.2 Assess arrange and confirm

It is helpful if sponsors or investigators contact Grounded Research as early as possible, ideally before regulatory approvals are in place. Initial feasibility discussion can begin at this point in the set-up process to explore whether Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH) have the capacity and capability required to run a study.

On receipt of the completed registration form and local information pack the research governance team will commence the capacity and capability assessment through collaboratively working with the research team, investigator, clinical colleagues and relevant support services.

  • Assessing, assessing whether the NHS organisation has the capacity and capability to participate in the study.
  • Arranging, putting any practical arrangements in place to provide the capacity and capability to deliver the study.
  • Confirming, confirming that the NHS organisation has the capacity and capability in place to deliver the study and will deliver the study.

4.2.1 Assessing

The feasibility assessment will be conducted by the Grounded Research study delivery leads, who will consider staff and resource capacity required to deliver the study. Feasibility and clinical interest will be discussed with relevant colleagues in the care groups. Review will include, but is not limited to, review of finance, contracting, support service involvement, patient population and research activities required.

4.2.2 Arranging

All research (except for those deemed as not requiring confirmation of capacity and capability) must be reviewed and approved by the research innovation panel, usually this will be at the monthly research panel meeting but may be conducted outside the meeting where timings do not allow review at a meeting.

The arranging stage includes coordinating Research and Innovation Panel review, review and authorisation of contracts and agreements, and internal approvals. All research governance checks must be completed before confirmation of capacity and capability can be issued.

Grounded Research staff will liaise with support services, for example where the study requires pharmacy or laboratory support and will arrange review and support service approval. In some cases, these activities may need to be sub-contracted to external organisations with an appropriate contract or service level agreement.

4.2.2.1 Internal trust approvals

Internal approvals are required for any research where there is involvement of clinical teams in the care groups and should be at an appropriate level for the research activity requested. The care group director, or nominated person, should review and provide agreement where there is a requirement for staff, facilities or financial implications for the care group. The relevant service manager or team leader for the area where the research will be conducted must be asked for their feedback on feasibility and will be asked to provide confirmation that they have no objection to the research taking place.

4.2.2.2 Finance and income distribution

Where there are payments made to the trust finance approval will be required. Depending on where the research activity takes place funding might be split between Grounded Research and the care group, to be decided on a case-by-case basis. Commercially sponsored research finance comes under the internal distribution of income from commercially sponsored clinical trials policy.

4.2.2.3 Contracting

An unmodified model contract should be used, and the contracting manager must review and arrange authorised signatures. The project cannot start until a fully executed contract or agreement is in place.

4.2.2.4 Information governance

All research will be discussed with the information governance manager to identify ant data protection and General Data Protection Regulation (GDPR) queries. Where a Data Protection Impact Assessments (DPIA) is required the sponsor or central research team should support completion by providing requested information. Refer to the Data Protection Act (2018) and research procedure.

4.2.3 Confirming

Once all internal checks are complete an email will be sent by the research governance lead providing confirmation of capacity and capability (CC&C). The signed model contract, agreement or organisational information document (OID) is attached to this email. No research activity can take place until confirmation of capacity and capability is issued.

5 Summary

The trust follows the Health Research Authority guidance on research governance review and setup. Sponsors and investigators are encouraged to contact the research governance team at the earliest opportunity to ensure there are no delays in the confirmation of capacity and capability process. The process for review comprises:

  • early engagement
  • submission of the local information pack
  • assess
  • arrange
  • confirm
  • issue confirmation of capacity and capability
  • open study to recruitment

6 Appendices

6.1 Appendix A research registration form template

Refer to appendix A: research registration form template (staff access only).

6.2 Appendix B contents of the UK local information pack contents

In summary the UK local information pack is made up of:

  • covering email using standard template format (refer to appendix 3): you will need to use the appropriate email template, please refer to the instructions below for sharing the local information pack
  • localised organisation information document (non-commercial studies: the outline organisation information documents submitted with the integrated research application system (IRAS) form application must be localised before sharing with participating NHS or Health and Social Care (HSC) organisations
  • UK Statement of Events or Schedule of Events Cost Attribution Tool (SoECAT): part of the UK local information pack for non-commercial studies only
  • relevant contract (commercial studies): in commercially sponsored studies the relevant model contracts or agreements form part of the UK local information pack
  • relevant supporting documents: these will include some of the documents that have been submitted or approved with the integrated research application system form submission and other documents to support study set up at the participating NHS or Health and Social Care organisations. Information about the documents to include is provided alongside the covering email templates provided. Must always include the regulatory approval letters or email, model contract, protocol, participant facing documents, data collection (case report forms (CRFs), questionnaires et cetera), advertisements, and any other documents required to deliver the research

The sponsor, or authorised delegate, is responsible for sharing the UK Local Information Pack with participating NHS or Health and Social Care organisations.

Further guidance and document templates are available on the integrated research application system (IRAS) website.

6.3 Appendix C useful documents and links

6.3.1 Regulatory guidance links

6.3.2 Guidance, toolkits and decision tool links

Document control

  • Version: 3.
  • Unique reference number: 432.
  • Ratified by: research and innovation group.
  • Date ratified: 11 November 2025.
  • Name of originator: research governance manager.
  • Name of responsible individual: chief medical officer
  • Date issued: 4 December 2025.
  • Review date: November 2028.

Page last reviewed: December 04, 2025
Next review due: December 04, 2026

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