Checklist 1

Research Checklist FOR CTIMPs in LTHT/UoL

Investigators checklist for submission of your research project to R&D

This list constitutes a ‘valid application’ for R&D Approval

Failure to submit all the required documents will result in a delay in review.

If your study is sponsored by LTHT or UoL you must liaise with the QA department to support your ethical and regulatory submissions.

Document Required
One copy of each document / Have you enclosed?
(Please tick) / Received
R&D Use Only
1.IRAS NHS R&D form with all appropriate signatures – in pdf and XML format. / IRMER Sign off (if radiation being used).
2. IRAS Site Specific Information (SSI) form for Leeds site with appropriate sign off – in pdf and XML format. / PI sign off.
Directorate sign off. (Q23 of IRAS SSI form or separate letter)
3. Research Protocol/Proposal (REC Approved)
4. Patient Information Sheet and Consent form (REC Approved Version)
5. GP letter (REC Approved Version).
6. Summary CV for all investigators named on SSI (signed and dated).
7. GCP Training - Documentary evidence for all investigators named on SSI within the last 2 years (if employed by LTHT or UoL).
8. Evidence of LTHT/UoL Consent training for staff taking consent in study (if employed by LTHT or UoL).
9. Evidence of insurance or indemnity (if separate to the Clinical trials agreement)
10. Sponsor agreement (if separate to the Clinical trials agreement)
11. REC favourable opinion letter and all supporting correspondence (including amendment information).
12. A copy of the MHRA application form and a copy of Confirmation of Clinical Trial Authorisation from MHRA and all supporting correspondence (including amendment information). / Application form.
Approval letter/s.
13. LTHT Pharmacy Clinical Trials Authorisation Letter
14. Pathology Approval letter
15. Histopathology Approval letter
16. Radiation approval letter and when appropriate ARSAC license and IRMER approval form / Radiology Approval letter.
ARSAC license.
IRMER Approval Form
17. All other REC approved documents.
18. A copy of the completed Industry Costing Template (if used).
19. Clinical Trials Agreement (submitted as early as possible to enable review and negotiation).

*CTIMP - Clinical Trial of Investigational Medicinal Product

Contact details for support Departments: (Pharmacy, Pathology, Histopathology & Radiology)

Pharmacy: Please contact Caroline Bedford, Clinical Trials Pharmacist, , 0113 392 2459, Fax number 0113 392 8279

Pathology/Labs: Please contact Clare Leeming, , 0113 392 2915

Radiology: Please contact Sheila Boyes, 'Radiology Research Manager', , Tel number 0113 20 64542, fax number 0113 20 65092

Histopathology: Please contact Dr Abeer Shaaban, her email address is , tel number is 0113 20 67754.

The list of forms that are needed for each support department, list of Directorate Research Leads and list of Directorate Finance Manager can be downloaded from our website. Here is the link to the website: http://www.leedsteachinghospitals.com/sites/research_and_development/keydocuments.php

Please note that there is an R&D Admin Fee for all commercially funded research hosted by LTHT

For further information please contact R&D, LGI - tel. (0113) 39 22878 or visit our website: www.leedsth.nhs.uk/sites/research_and_development

Note: A study cannot start until an R&D approval letter has been issued

from R&D Dept.

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Checklist 1

Guide to the R&D Approval process

All Trusts must comply with national Research Governance standards. Trusts must ensure that all research that in their organisation has R&D approval.

All research must be registered and approved by the Trust. This includes all projects using Trust staff, patients, their tissue, organs or data or using Trust facilities or equipment. The Trust will only extend NHS indemnity cover (for negligent harm) to its employees taking part in projects that have been registered with the R&D Department. The Trust will not accept liability for research that has not been registered and managerially approved.

All research must have a Sponsor. Under UK Law, the Sponsor is an institution or individual that takes responsibility for the initiation, management and financing of a project. Detailed guidance is available on the R&D website http://www.leedsth.nhs.uk/sites/research_and_development/sponsors.php

What must I send to R&D?

·  An electronic copy of all documents on the Research Checklist.

But the following signed paper copies must be submitted (the relevant pages, rather than the full document are acceptable):

·  Signatures of the local Principal Investigator and Directorate Research Lead (or other authorised departmental manager) (this can be a separate letter or incorporated in Q23 of IRAS SSI Form).

·  If you are unsure who your research lead is, look at http://www.leedsth.nhs.uk/sites/research_and_development/documents/Listofresearchleadsandclinicaldirectors_028.pdf

·  Signature of Research Sponsor from relevant page of IRAS R&D form (photocopy) or on separate letter or agreement

Definitions

·  Directorate Approval - Confirmation that your Directorate has agreed the project can proceed and adequate facilities and support are available. (Please see ‘List of research leads and clinical directors.doc’ for these details).

·  Peer Review - An independent and expert, documented review of the project. For full guidance please see ‘peer review.doc’.

·  Honorary Contract - All members of the research team must have an employment contract (full or honorary) with the Trust. For full guidance please see ‘Honorary Contract Guidance.doc’.

·  CTIMP - Clinical Trial of an Investigational Medicinal Product (performed under GCP and regulated by the MHRA).

·  Indemnity Agreements for Commercial Studies - The project should be covered by Association of British Pharmaceutical Industry (ABPI) or equivalent “no fault” indemnity. The agreement must be reviewed and signed on behalf of the Trust by Dr Derek Norfolk, Associate R&D Director.

·  Evidence of GCP training for CI (if based in LTHT) and the PI. GCP training should be undertaken at least every 2 years. Documentary evidence of this must be submitted with each CTIMP application.

·  NRES - National Research Ethics Service

·  MHRA - Medicines and Healthcare products Regulatory Agency.

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