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rec and regulatory submissions

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REC & Regulatory Submissions

A research study cannot start until all the relevant permissions and approvals have been obtained and are evidenced in the Study/Trial Master File (S/TMF).

All research which falls within the scope of the UK Policy Framework for Health and Social Care Research requires NHS permission. This includes research that involves NHS patients, their tissue or information, staff, equipment or other resources of the NHS. Not all health research however requires approval from an NHS Research Ethics Committee (REC). The HRA decision tool will help you to determine if your study requires ethical approval.  

Clinical Trials of Investigational Medicinal Products (CTIMPs) require Clinical Trial Authorisation (CTA), favourable opinion by a ‘recognised’ ethics committee and host site approval. It is a criminal offence to conduct a CTIMP anywhere in the UK without a CTA.

Which permissions and approvals are required are essentially determined by the study type, the study population under investigation and where the activities will take place.  If a request for sponsorship by a Noclor partner is being made, Noclor will advise on what approvals will be required early on in the study development stages.

When can you apply for approval?

Declaration of sponsorship and confirmation of funding (where relevant) are required before applications for the relevant approvals can be made.  The required applications should be made in parallel via Integrated Research Application System - IRAS (unless otherwise stated). 

IRAS contains extensive online guidance to support researchers in completing their application forms.

 

Preparing and submitting your initial applications

The Chief Investigator is delegated responsible (unless otherwise stated in the Delegation of Responsibilities Agreement) for preparing and submitting applications for approvals ensuring that:

 

  • sponsorship has been agreed by a Noclor partner prior to a request for sponsor declaration being made through IRAS 
  • the relevant IRAS forms are complete and accurate (and do not contradict the protocol)
  • the necessary supporting documents are prepared, clearly referenced and version controlled and attached to the relevant applications (according to the IRAS submission checklists)
  • the entire submission pack (including supporting documents, checklist and cover letter) is sent electronically to the Noclor Sponsor Representative at the time an electronic authorisation of sponsor representative is requested
  • the required declarations are sought from appropriate personnel (only authorised Noclor sponsor representatives can declare on behalf of sponsor). Where wet ink signatures are still required (instead of electronic signatures), the Chief Investigator should scan and save an electronic file of the signed page and retain a copy of the (wet) signed application in the Study/Trial Master File (S/TMF).
  • the IRAS instructions about submitting applications are followed  (review bodies have their own procedures)

 

Important note for CTIMPs - CTA submissions can only be made by an authorised Noclor Sponsor Representative (or by someone authorised to submit the request on Noclor’s behalf).

 

By signing the IRAS Declaration on each application, the Chief Investigator is legally agreeing to the contents of the application and will be personally liable for any deviation from the agreement

After the initial submissions have been made

If there any changes to information or documents in the course of the review process, it is important that this information is communicated to the Noclor Sponsor Representative (sponsor) and all the relevant bodies that are reviewing your study and retain accurate records (including all correspondence).

Approvals should be sent to the Noclor Sponsor Representative so that final checks can be made prior to the sponsor issuing a study activation notice. Once your study has been approved you must keep the sponsor and all relevant review bodies informed of any changes to the study.

If your research study is abandoned prior to activation (or following rejection/non-acceptance by any of the review bodies) please notify the Noclor Sponsor Representative in writing.