Checklist 2

Research Checklist 2

FOR non-CTIMPs which are to beSponsored by LTHT

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

This list constitutes a ‘valid application’ for confirmation

Research Governance Sponsorship in principle.

We cannot process incomplete applications. These will be returned to the investigator.

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

R&D will review and respond within 25 days of receipt of a valid application.

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 .
  1. 2. IRAS REC form (hard copy with all signatures) - ready for Ethics submission

3. 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 orseparate letter)
4. Radiology Approval letter (if applicable)
5. Pathology Approval letter (if applicable)
6. Histopathology Approval letter (if applicable)
7. Research Protocol/Proposal
8. Certificate of ARSAC (if applicable)
9. IRMER form - signed (if applicable)
10. Evidence of Peer Review
11. Summary CV for PI and all researchers listed in section 5 of the SSI Form - signed and dated
12. Patient information sheet and consent form on LTHT headed paper
13. Any other documents which will be submitted to Ethics Committee
14. Do you intend to transfer tissue in or out of the LTHT? If yes, you need to complete the relevant TTA?

**

*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:

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:

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

from R&D Dept.

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

Sponsor Confirmation before Research Ethics Submission

Where LTHT is the Research Sponsor, NRES now require us to confirm Sponsorship (agreement in principle to sponsor) BEFORE submission to the Ethics Committee. This requires detailed review and adequate time to fulfil our obligations under Research Governance. PLEASE NOTE Final R&D Approval will be required before the project can go ahead.

The complete document set MUST be submitted to R&D at least 10 working days BEFORE any REC deadlines (please be aware that sign-off may take long if incomplete documentation is submitted or issues are identified.)If you book the application with NRES before notifyingthe R&D Department, you run the risk of missing your ethics committee slot. It is the Chief investigator's responsibility to allow sufficient time for R&D review before submission for Research Ethics review.

For CTIMPs, which are governed by GCP the R&D Quality Assurance Team MUST be contacted at the earliest opportunity. They will guide you through the process and NO REC application can be made until this process is completed.

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.