NHS Research Scotland (NRS)
List of documents for commercial submission
Please complete this checklist and send it with your application:
Please send a CD containing one file for each document. Application form files should be saved in both pdf and XML formats.
Where signed documents are required, please send one of: a hard copy, a faxed copy or a scanned electronic file. Check that the
submission code appears on each page of the ethics application form before sending. It is acceptable to send hard copies of signature
pages separately, as long as the submission code at the top of the page is the same as on the electronic version.
All letters must be dated. All other accompanying documents must bear version numbers and dates.
All documents listed below that are applicable must be submitted for the application to be valid.
When sending hard copies, please do NOT staple documents as they may need to be photocopied.
Project Title:
Documents required for submission:
Document Yes/No/Not File Name Version
Applicable
Research protocol & any current amendments
Summary CV for Chief Investigator (CI) or Research
Passport
http://www.nihr.ac.uk/systems_research_passports.aspx
Summary CV for Principal Investigator(s) (PIs),
signed and dated or Research Passport
Research participant information sheet (PIS)
Research participant consent form
Evidence of current insurance/indemnity
IRAS R&D Parts A-D
(Locked PDF and XML) signed copy
IRAS Site-Specific Forms for all participating sites
(saved in PDF and XML) signed copy
A list of sites in which the study will be conducted,
including hospital name, department and PI
REC favourable opinion letter and all correspondence
Confirmation of REC favourable opinion for any
substantial amendments
Confirmation of clinical trial authorisation from MHRA
and all correspondence
Confirmation of authorisation from MHRA for any
substantial amendments
Confirmation of any other regulatory approvals
(ARSAC)
Draft mCTA
Version 1 (05/03/09)
Completed copy of this checklist
MCRN Costing Model Unlocked or proposed study
budget
Note: All documents should be copied onto CD which should include a scanned version of any signed pages of the
application.
Files should be saved as pdf, XML or Word files only. Other file versions cannot be accepted.
Applications with blank signatory sheets unfortunately cannot be accepted. One original paper copy of all pages of
the applications should be included with the CD and sent to the address below:
Please note: Applications will not be validated until full document set has been received.
NHS Research Scotland Coordinating Centre
Research & Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
Tel: 01224 552 690
e. gg-uhb.nrs@nhs,net
Version 1 (05/03/09)