Local Trust Management Approval or Confirmation of Capacity and Capability and Ongoing Study Oversight

Researchers should contact the R&D office as soon as possible when they become aware that they may be participating in a research study or clinical trial.

In order to confirm capacity and capability to participate in the research, the R&D office will require copies of all study documentation. The information provided enables the Trust to assess the impact of the study on the organisation - feasibility, capability, research costs and general level of risk.

Additionally the study team should provide approval from the following organisations.

IRMER Practitioner / Medical Physics

For studies using ionising radiation, where OUH is not the lead site (and therefore the signatures on the R&D form are not from OUH) the signature of the local Radiation Protection Officer and IRMER Practitioner for the site where the research is taking place must be obtained. For studies involving histopathology you will need to supply evidence that they have reviewed the study.

If your proposed study has any commercial involvement; involves a third party; is multicentre; or is a clinical trial you may need to have a contract/agreement in place. It is essential that, whenever possible, standard DOH templates are used. This will considerably reduce the time needed to review these.

Please seek advice from R&D at the earliest opportunity:

• ouhtma@ouh.nhs.uk

Draft contracts should be emailed with a copy of the final protocol to:

ouhcontracts@admin.ox.ac.uk

OUH Trust Management Approval cannot be given until all other relevant regulatory or other approvals (e.g. HRA, REC, MHRA, and NIGB) are in place. If your study involves a contract or agreement, this will also need to be fully executed before we can release your approval letter.

Recruitment must not begin until all approvals are in place because the study would not be indemnified by the Trust.

To maintain ongoing Trust Management Approval it is necessary to provide the R&D Department with copies of Annual Progress Reports and if applicable, Annual Safety Reports.

University Hosted Studies (non-NHS SSI form)

For studies carried out on University premises, a non-NHS SSI form may be required. All Site Specific Assessments (SSAs) for non-NHS sites are now undertaken by the main REC carrying out the ethical review of the research ethics application.

Feasibility Review for IRAS Top Four Category Research

If your proposed research at OUH is in one of the following four categories, before you apply for Trust approval you need to contact the R&D Team to undergo a feasibility review.

• Clinical trial of an investigational medicinal product
  
• Clinical investigation or other study of a medical device
  
• Combined trial of an investigational medicinal product and an investigational medical device
  
• Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice

The Feasibility questionnaire can be downloaded below.

• Feasibility Questionnaire (Word, 663 KB)

Please forward the completed form to ouhtma@ouh.nhs.uk

Feasibility review is part of a larger project management focused overview that R&D will help ensure that both the first patient to a trial is recruited within the NIHR target of 70 days, and that the trial recruits all contracted participants by the target date wherever possible.

Topics to be considered

• Disease area and number of potential participants seen in OUH clinics against inclusion and exclusion criteria in the proposed protocol and the target suggested by the sponsor?
• Other competing research?
• Approvals by steering groups and management team?
• Capacity of clinical area and team - are all staff already in post?
• Will the proposal fit with the current care pathway for patients?
• Service support department involvement and capacity?
• Costing and agreement to fund by spondor?
• Contractural framework for research?
• Is there a site initiation visit already booked?

Only once the feasibility has been received and approved, on behalf of the Director of R&D can the proposal proceed to SSI submission.

Research Tissue Banks / Research Data Banks

Research Tissue and Data Banks are not included in the HRA approval process and any researcher wishing to take part in either of these will be required to apply to the OUH R&D office for Trust Management Approval.

OUH requires that all Research Tissue Bank (Biobank) and Research Data Bank (Database) applications be submitted to an NHS REC for ethical review.

Research proposal documents must be sent to the R&D Team for review before submission to a REC and/or the Human Tissue Authority (HTA).

For full details, please refer to our Research Tissue Banks / Research Data Banks page.

Research Tissue Banks / Research Data Banks

Trust Management Approval application documents

The exact documents required will depend on the nature of the research. The following list gives general guidance and further advice is available from:

ouhtma@ouh.nhs.uk

1. IRAS R&D Form
   With Radiation Protection signatures if appropriate.
2. HRA Statement of Activities
   This document is generated by the sponsor of the research
3. HRA Schedule of Events
   This document is generated by the sponsor of the research
4. Draft Template Contract
   If your study has any commercial involvement, involves a third party, is multicentre, or is a clinical trial, you may need to have a contract/agreement in place.
   It is essential that whenever possible standard DOH templates are used: Model Agreements
   Please seek advice from R&D at the earliest opportunity.
   Draft contracts should be emailed with a copy of the final protocol to: ouhcontracts@admin.ox.ac.uk
5. Local Approvals
   For studies using ionising radiation, where OUH is not the lead site (and therefore the signatures on the R&D form are not from OUH) the signature of the local Radiation Protection Officer and IRMER Practitioner for the site where the research is taking place must be obtained.
   For studies involving histopathology you will need to supply evidence that they have reviewed the study.
6. Evidence of Independent Scientific Review
   Details of acceptable forms of peer review are available on this website: Peer review
7. Evidence of Funding
   If you have been awarded specific funding for a project, then please enclose a copy of your funding award letter.
   If you have no external funding you need to provide evidence of study costs and how the study will be funded.
8. Protocol - final approved version
9. Investigator's Brochure or SMPC for CTIMPS
10. Participant Information Sheet and Consent Form - final approved versions - locally headed
11. Any other relevant documents - e.g. GP letter, recruitment advertisements - locally headed
12. Short CVs for all study personnel taking part in the research at OUH, with evidence of GCP training in the previous three years (signed and dated)
    Template available on HRA website or from R&D
13. Evidence of Sponsorship
    Each project must have a nominated Sponsor. You must provide a letter from your nominated Sponsor confirming their acceptance of this role.
    Information on whom is likely to be the Research Sponsor for your project and the associated responsibility is available on this website.
14. Clinical Trials Authorisation / letter of no objection for all CTIMPs and those device trials that need approval by the MHRA
15. A copy of the Ethics Approval letters
16. A copy of the Health Research Authority approval letter

IRAS website - www.myresearchproject.org.uk

Feasibility Questionnaire (Word, 663 KB)

ouhtma@ouh.nhs.uk

tvclrn@nhs.net

ouh.csp@nhs.net