How will documents (e.g. protocols, PIS etc) move through the NIHR CSP process?
A. IRAS does not have the capability of handling documentation to support of a submission. This will need to be supplied to the Lead CLRN or the local CLRN via email (depending on study type). Approval letters from regulatory bodies and other documentation required for the research governance review of the study should be sent to the Lead CLRN (whom the CI should be in contact with) as soon as received. This will aid CSPU to process the study as fast as possible. R&D Forms should be sent to the Lead CLRN; SSI Forms should be sent to the local CLRN. Q. If the CLRNs do no need to start the clocks for a study until the SSI Form has been received, what happens if the researcher does not need to submit an SSI Form because the project is Site Specific Exempt? A. The local clock should start on receipt of the SSI Form as this is when the information for the local R&D is supplied. If a study is site specific exempt, then a PI (on behalf of the CI) should still be completing the SSI form for NH