Insurance Application for Projects Requiring Approval by Ethics - DOC by Tqurg9

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									Insurance and Research Governance Application for Projects Requiring Approval by Ethics
Committee and Involving Research on Human Subjects, their tissues, organs or data, by Staff
                    and/or Students of the University of Southampton
The project must not commence until insurance, ethics approval and sponsorship are obtained

PART A - PLEASE COMPLETE ALL QUESTIONS
      Ethics Submission Number:
      Title of
1.    Study:


      Start date:        (dd/MM/yyyy)                End date:   (dd/MM/yyyy)

      Researcher’s Details
      Title:   Mr/Mrs/Miss/Ms/Professor/Dr   Name:
      University School:
      University Department/Division:
2.    Address:



      Tel:                                           Email

3.    Are student researchers involved with this project?                                             Yes      No
      Is the study based solely on questionnaires, or other research not involving invasive
4.                                                                                                    Yes      No
      techniques or medicinal products?

      Please estimate numbers of volunteers participating in the study:                               Adults       Minors *
                                                                     Patients
                                                                     Healthy human volunteers
                                                                                         * Minors under 18 years of age

5.    Is this a Multi Centre Trial?                                                          Yes      No
      If yes and the trial is sponsored by UoS or SUHT, or managed by UoS, please estimate numbers of volunteers
      participating in the study overall:
                                                                                             Adults     Minors
                                                                     Patients
                                                                     Healthy human volunteers

6.    Does the study involve invasive techniques?                                                     Yes      No
      Does the study involve the use of a medicinal product or the testing of a medical
                                                                                                      Yes      No
      device?
7.
      IF AN INVESTIGATIVE MEDICINAL PRODUCT IS INVOLVED
                                                                                                Phase 1, 2, 3, 4
      Please indicate which phase category the study falls into

8.    Who is the Research Sponsor?
9.    Who is the Funder?
10.   For Commercial trials only, is an ABPI Indemnity being given?                                   Yes      No
IF YES: the ABPI Indemnity form, preferably in triplicate, should be forwarded with this form for signature by an
Authorised Signatory on behalf of the University.
Will any part of this study take place outside the UK?                                                Yes      No
If Yes, in which country(ies)?

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PART B - PLEASE COMPLETE QUESTIONS AS APPLICABLE

          For Student projects                Student status: UG/PG/IVth medical student
          Supervisor’s Details
          Title:     Mr/Mrs/Miss/Ms/Professor/Dr   Name:
          University School
11.       University Department or Division
          Address:



          Tel:                                             Email

          For multi site studies
          How many sites are involved?
12.
          Is Southampton the lead site?
          Are any sites outside the UK?
          Are contracts/site agreements in place?

          For studies involving the NHS Patients, staff or resources

13.       Is the study approved by the NHS Trust R+D office?                               Yes    No      Pending

          Is the study approved by NHS ethics committee?                                   Yes    No      Pending

          For Clinical Trials involving drugs, devices or clinical interventions                 Reference Number
          Is the study registered with the MHRA?                             Yes     No
14.       Is the study registered on the European Clinical Trials
                                                                             Yes     No
          (EudraCT) database?
          Is the study registered on the National Research Register
                                                                             Yes     No
          (Clinical trials database)?
          For studies using tissue samples
15.       Are the tissue samples accessed via a licensed tissue bank?                              Yes      No
          Are you seeking ethical approval for your study?                                         Yes      No
          For all studies, will the Applicant be responsible for:
16.       Reporting amendments to the protocol                                                     Yes      No
          Reporting adverse events and significant developments                                    Yes      No
          If No, who will be responsible?
For Research Governance information, please contact:
Research Governance Office,                            Email: rgoinfo@soton.ac.uk                      Tel: 02380 598849
Website:     http://www.soton.ac.uk/corporateservices/rgo/index.html
For Insurance information, please contact:
Finance Department, Insurance Services,                         Email: insure@soton.ac.uk              Tel: 02380 592417
Website      http://www.soton.ac.uk/finance/insurance/index.html


Please send this form with all other supporting documents to:
Research Governance Office, University of Southampton, B37/4055, Highfield, Southampton SO17 1BJ
or email to rgoinfo@soton.ac.uk.




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