Permissions Coordinating Centre
Documents for Commercial Submission /
Please complete this checklist and send it with your application.
- All applicable documents listed below must be submitted, for the application to be considered complete.
However, reviews can start prior to receipt of a REC Favourable Opinion/Acknowledgement Letter and MHRA
Authorisation letter (if applicable).
- Please email us the document set: 1 file for each document saved in pdf or Word format.
- Email the IRAS R&D Form to us in .XML format as well as in .pdf or Word format.
- All documents submitted to a REC should also be submitted to NRS Permissions CC.
- Where signed documents are required, please send a scanned electronic copy.
Document / Yes, No, N/A / File Name / Version
R&D and Ethics
IRAS R&D Form (Parts A-D), or NRES Ethics Form (Parts A&B) if pre-IRAS, (with CI & Sponsor signatures)
REC Favourable Opinion Letter, or GTAC Approval Letter
[NB: GTAC is the main REC for gene therapy clinical trials].
[NB: Scotland A REC favourable opinion (for non-CTIMP studies involving adults with incapacity (AWI))].
REC Favourable Opinion Letter for Amendments,
or GTAC Approval Letter for Amendments
REC acknowledgement letters
Reminder: Don’t forget to arrange for IRAS Site Specific Information (SSI) Forms to be sent to participating Health Board PIs; or for ‘no local investigator studies’, a CI-signed Generic SSI Form to be emailed to NRS Permissions CC.
Regulatory Approvals
MHRA Clinical Trial Authorisation and all correspondence
MHRA authorisation of any substantial amendments
MHRA “Notice of No Objection” Letter (Medical Device study)
Confirmation of other regulatory approvals, eg. NIGB-ECC
Finance and Agreements
UK CRN Industry Costing Template (unlocked),
or proposed Study Budget
Co-sponsor Letter or signed Agreement(if study is co-sponsored)
Contracts/Study Agreements/Site Agreements (draft)
NB: If current Scottish model contracts are not used “as published”, NRS cannot guarantee R&D permission within 30 cal. days
Evidence of current Insurance/Indemnity
Project Information (dated, version numbers) / Yes, No, N/A / File Name / Version
Protocol (including related laboratory, imaging manuals)
Participant Information Sheet (PIS)
Participant Consent Form (blank)
Letters of Invitation to Participant
GP/Consultant Information Sheets or Letters
Sample Diary Card / Patient Card
Interview Schedules or Topic Guides for Participants
Copies of Advertisement Material for Research Participants, eg. posters, newspaper adverts, website
Questionnaire(s)
Investigator Information
CV for CI (signed and dated)(abbreviated is acceptable)
Amendments (dated, version numbers) / Filename / Version
Notice of amendment(s)
Amendment(s) ie. copy of amended documents
Other
Completed copy of this checklist
Please note: Applications will not be considered complete until a full document set has been received.
Applications with blank signatory sheets unfortunately cannot be accepted.
Confidentiality
If Confidential Disclosure Agreements (CDAs) (Master or Project-specific) are required by the Sponsor, you may
send us a Sponsor CDA template or request the NRS CDA template.
Amendments
Should you now or in the future create an amendment to your study, please email all amendment-related documentation to NRS Permissions CC at the same time you submit to ethics.
What happens to the documents?
Once NRS Permissions CC receives your documents, they are uploaded onto a secure, access-controlled, web-based national database called SReDA (Scottish Research Database Application), to allow only participating Health Board R&D staff to review the documents.
You may be contacted by a local R&D office for specific locally-required documents – this is separate from those documents required by NRS Permissions CC for the global governance checks.
NHS Research ScotlandPermissions Coordinating Centre
(NRS Permissions CC)
Research & Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
Tel:01224 552 690
Email.
NRS Permissions CC Commercial document list, version 9, June 2012 Page 1 of 2