Approve IRAS submission
Before approving submission of the relevant IRAS forms, the Clinical Division research manager must satisfied that the following are in place (where applicable):
1. IRAS NHS R&D form and IRAS REC form. The forms must be signed and the final versions for the submission to be classed as a valid application.
2. IRAS SSI
3. Protocol (final REC approved/submitted version).
4. Participant information sheet and consent form (final REC approved/submitted version on Trust headed paper)
5. Study specific documentation approved by the REC (eg patient diary cards)
6. REC favourable opinion letter (if available at time of submission to us)
7. CI/PI CV, and all CVs for the research team listed in the SSI (signed and dated).
8. Clinical Division authorisation – an email is sufficient evidence – please contact the Clinical Division Research Manager.
1. Certificate of ARSAC approval
2. A copy of the MHRA CTA authorisation letter
3. Confirmation of authorisation from the MHRA for any substantial amendments
4. Confirmation of REC favourable opinion for any substantial amendments
5. Any other approval documentation that is relevant to the study (NIGB approval, GTAC etc)
6. Confirmation from support departments that their involvement is agreed (emails are acceptable proof)
The start point (Day 0) for the NIHR’s 30-day target to achieve NHS permission is the receipt of a valid R&D application pack.
|Type||Where to find|
|Key contacts||Clinical Divisions; JRCO|
|Useful links||IRAS homepage
NIHR Clinical Trials Toolkit - IRAS
|NIHR benchmark||Prior to NIHR 70-day benchmark|
|Process map links||This activity occurs in the work-up stage:
> Imperial College London as sponsor
> Imperial College Hospital NHS Trust as sponsor
> Commercial organisation as sponsor
> Non-commercial organisation as sponsor