Essential Documents Checklist for
Non-CTIMPs NOT sponsored by LTHT/UoL
This list constitutes a 'valid' application' for R&I Approval.
Incomplete applications cannot be processed and will be returned to researchers.
Failure to submit all required documents will result in a delay in review and possible invalidation of your application.
DOCUMENTS REQUIRED
One copy of each document
ENCLOSED RECEIVED
Please tick For R&I use
IRAS NHS R&D Form with all appropriate
signatures - in PDF and XML format
IRAS Site Specific Information (SSI) Form for
Leeds site with appropriate signatures - in PDF
and XML format
CSU Approval
Chief Investigator (CI) sign-off
Sponsor sign-off
IRMER sign-off (if radiation being used)
Principle Investigator (PI) sign-off
Summary CV for CI, PI and all researchers listed in section 5 of the SSI Form (signed and dated
within last two years)
Good Clinical Practice (GCP) training certificates for CI, PI and all researchers listed in section 5 of
the SSI Form - if employed by LTHT or UoL (signed within last two years)
Informed Consent training certificates for LTHT or UoL employed staff taking consent in study
MHRA Application Form and resulting MHRA
Application Form
Confirmation of Clinical Trial Authorisation and
all supporting correspondence (inc. amendment
Approval letter(s)
information)
MHRA Medical Device - Off-label Device Approval
LTHT Pharmacy Clinical Trials Authorisation letter
Radiology Approval
LTHT Radiation approvals when appropriate to
IRMER Approval
the design of the study
ARSAC license
Pathology Approval
Histopathology Approval
REC favourable opinion letter and all supporting correspondence (inc. amendment information)
Research Protocol/Proposal (REC Approved)
Information sheet and Consent form (REC Approved)
All other REC Approved documents
Clinical Trials Agreement (submitted as early as possible to enable review and negotiation and
avoid delay in R&I approval)
Evidence of Insurance or Indemnity (if separate to the Clinical Trials Agreement)
Sponsor Agreement/Financial Agreement or equivalent (if separate to the Clinical Trials
Agreement and applicable)
Tissue Transfer Agreement (if tissue samples are to be transferred in or out of LTHT)
R&I will review and respond within 25 days of receiving a valid application.
*CTIMP - Clinical Trail of Investigational Medicinal Product
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Guide to the R&I Approval process
All Trusts must comply with national Research Governance standards. Trusts must ensure that all research in their
All research must have a Sponsor. Under the law, the Sponsor is the institution that takes responsibility for the initiation,
What must I send to R&I?
• An electronic copy of all documents on the relevant Essential Documents Checklist
• CSU Approval - confirmation that your CSU has agreed that the project can proceed and adequate facilities and
support are available (Please see the latest Trust Structure charts for details of your CSU Research Lead)
• Signatures of the Research Sponsor and Chief/Principle Invsetigators must be on the R&D/SSI Form (Normally
signed electronically via IRAS)
Definitions:
Indemnity for Commercial Status - the project should be covered by the Association of British Pharmaceutical Industry
(ABPI) or equivalent 'no fault' indemnity by the commercial sponsor.
IRAS - Intergrated Research Application System. This website includes exclusive advice for preparing research documents.
CTIMP - Clinical Tiral of Investigational Medicinal Product (regulated by the MHRA)
MHRA - Medicines and Healthcare products Regulatory Agency. MHRA also regulates research involving medical devices.
Peer Review - an independent, expert documented review of the projest. Full guidelines available on our website.
Key Service Support (KSS) Departments
You must get permission from any Trust service departments that may be required to support your research. Contact
details of LTHT support departments can be found on our website.
NIHR Clinical Research Network (CRN) Portfolio - access to NHS infrastructure for research and training and includes
includes NHS Service Support and Research Management and Governance Support.
www.leedsth.nhs.uk/research
Checklist non-LTHT v040914