Sponsorship and review

When to make contact

Get in touch at the early stages of study planning. Seeking sponsorship early helps ensure your research is on track from the start and avoids unexpected delays later on.

Sponsor approval is required before:

• Applying for Research Ethics Committee (REC) review
• Requesting NHS R&D Management approval
• Submitting for any other research approvals

The sponsorship review can take up to 10 working days, depending on the complexity of your study and how quickly you respond to feedback. If a Risk Assessment is needed, your Sponsor Representative will advise and explain this process.

What to send to Research Governance

Send the following documents, where applicable, to the Research Governance team for review:

• Draft protocol
• Draft ethics form (IRAS form for studies needing NHS REC/R&D approval, or visit the EMREC site)
• Participant Information Sheet
• Consent form
• GP letter
• Any other documentation, e.g. questionnaire, poster, advert
• Brief CV for the Chief Investigator (and student if applicable)
• If NHS staff or resources are involved, a Local Information Pack (i.e. Schedule of Events Cost Attribution Tool (SOECAT) or Schedule of Events (SoE) and Organisational Information Document (OID)

What if my study is a clinical trial?

Clinical trials are typically more complex than other types of research. They require careful planning, close collaboration across teams and, in some cases, regulatory approval from bodies such as the MHRA. Regulated studies can include:

• A Clinical Trial of an Investigational Medicinal Product (CTIMP)
• A Clinical Investigation of a Medical Device (CIMD)
• A combined drug and device trial

When you contact the Research Governance team, we will assess whether your clinical trial requires additional support and provide guidance accordingly.

• Once we receive your research study documents, a unique Sponsor number will be assigned - please include this in all future correspondence.
• A Sponsor Representative will be allocated to review your full document set. They may request additional documents if needed. After the initial review, you’ll receive a feedback document outlining comments, suggestions, and any required changes.
• To keep the process moving, please respond to the feedback promptly and return any revised documents for further review.

How long does the review take?

The review typically takes up to 10 working days, depending on the complexity of your study and the speed of your responses. If a Risk Assessment is required, your Sponsor Representative will let you know. Once all feedback has been addressed, the study will receive sponsorship approval.

Your Sponsor Representative will guide you through the research approval submission process, including how to obtain:

• REC favourable opinion
• NHS R&D Management Approval (if required)
• Any other necessary research permissions

They will also provide insurance documentation if required. 

Please note: ACCORD does not issue separate Sponsor letters, as our authorisation on the ethics form confirms our agreement to act as Sponsor. If a formal letter is needed, speak to your Sponsor Representative.

⚠️ Important:

Please do not submit for research approvals before obtaining sponsorship. Failure to do so may delay your study. ACCORD cannot agree to sponsor research that has already started.

When can you start your study?

Unless advised otherwise by your Sponsor Representative, you may begin your study once:

• You have received a favourable REC opinion
• All REC conditions have been addressed
• You have NHS R&D Management Approval (if required)
• Any other necessary research approvals are in place