I want to add some more research sites to my study. What should I do?
If a study gained its NHS Permission via CSP or is still proceeding through CSP, the Chief Investigator or Study Coordinator should add the new research sites to Part C of the R&D form and resubmit this through IRAS, informing the Lead CLRN. A governance review of the new sites will be undertaken in the usual way. Please note, for CTIMP studies, the addition of new sites is a substantial amendment. It is not currently permissible to use NIHR CSP for the addition of new research sites to a study that did not use NIHR CSP to gain NHS Permission for the existing sites.
How are amendments to studies that have gone/are going through CSP handled?
The process for handling amendments to studies that have gone through CSP is available here. In summary, Trusts have a maximum of 35 days after a CI/sponsor has submitted an amendment to raise an objection otherwise the default is that it can be implemented at each site where an objection has not been raised, subject to regulatory approval. A complete amendment application should be submitted to the Lead Comprehensive Local Research Network (CLRN), this is the CLRN which processes the original NIHR CS where the CI is based. Please contact the Lead CLRN for your study for further guidance. Download the CLRN contact members
Can a Trust approve an amendment before the 35 days are up?
Yes, providing all necessary regulatory approvals have been received, a Trust can choose to approve the amendment in a shorter timescale.
Does a sponsor have to submit in their amendment application to NIHR CSP in parallel with their ethics/MHRA application?
It is not essential that a sponsor submits in parallel. Sponsors should be aware however, that if they wait unit they receive regulatory approval before making their application to NIHR CSP, participating Trusts will still have 35 days from receipt of the valid application by the Lead CLRN in which to make their decision. Therefore from the sponsor's perspective, it is more time effective to submit applications in parallel
How do I identify the Lead NHS R&D contact for my study?
The Lead NHS R&D contact could be the R&D office of the Chief Investigator’s (CI) employing NHS organisation; a partner NHS organisation of the HEI employing the CI; the R&D office where the sponsoring organisation is based; the R&D office of a main NHS collaborator; the site where the study is first initiated; or a combination of these. Please discuss and agree this role with the NHS Trust R&D office before submitting any forms through IRAS.
When selecting the Lead Comprehensive Local Research Network (CLRN) is IRAS, you are advised to select the CLRN of which the Lead NHS R&D office is a member organisation.
My study is part of a programme grant. How is it managed through CSP?
Projects that are nested within programme grants will be treated as separate studies in CSP. Each project will also be considered separately for inclusion in the NIHR CRN Portfolio. Details of the grant award should be provided in section 9 of the CSP Application Form.
Where should I send documents which will support my R&D Form and SSI Forms?
Once the R&D Form and the SSI Forms(s) have been validated, you will be sent an email confirming your study’s progress through CSP, and providing the CLRN contact email address to which the supporting documents should be sent.
I have noticed an error on my SSI form, but I cannot seem to resubmit it. What should I do?
It is not possible to resubmit a SSI form through IRAS once it has been accepted by the CLRN. The creator of the project in IRAS should highlight the appropriate SSI Form, and select the ‘Duplicate this SSI form’ option in the Manage tab in IRAS. As indicated this creates an exact copy which can be amended and submitted through IRAS to the CLRN.
