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From the 1 April 2007 it will become mandatory that the sponsor declaration page of the Ethics application form is signed by the sponsoring organisation.
For those studies that require sponsorship by the Trust or the Trust and University jointly, the declaration page will need to be signed by the R&D Department.
For signing of the sponsor declaration page:
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Complete the application form and obtain the REC number from ethics as is the normal practice, then E-mail your locked form and protocol to r&denquiries@addenbrookes.nhs.uk stating in the subject line – Sponsor Declaration Page
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An R&D Officer will look at your study that day and will make arrangements for the form to be signed.
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Once the form is signed we will let you know when it can be collected from the R&D Department.
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You will then be able to submit the signed hard copy to an Ethics Committee.
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Upon receipt of a valid letter from Ethics, the R&D Department will commence the approval process and an R&D Officer will be in contact regarding your study should there be any queries.
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You should also send to us at some stage the signed SSI form which should have been signed by the SDU Director, Clinical Director or Head of Department in which the study will take place.
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Please note that when the department signs the declaration page your study has not been approved, we have only confirmed that we will be the sponsoring organisation.
Only when you receive ethics approval and the R&D Approval and Sponsor letter will you be able to start your study.
If you have any queries regarding this process please contact the R&D Officers
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