Carrying out Research > R&D Approval
The following list outlines what we need from you in order to provide R&D approval for your study. Please note that research must not commence without a formal letter of R&D approval being received.
Please make your submissions to the R&D Directorate, Wythenshawe Hospital (contact) - you can send everything in one package, or send parts at any stage of the process (e.g. at the same time as applying to the ethics committee). We will happily accept documentation via email. Download GMRA checklist
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For all studies: |
 Pan Manchester R&D Notification form (download form and guidance notes) NB - this is now the 2007 version |
Copy of Research Ethics Committee (REC) Application form (all sections) |
| New: Site-specific information (SSI) form (available via REC application) with investigator CVs |
Copy of REC approval letter |
Study protocol |
Patient Information sheets and Consent forms (REC-approved version) |
| AND... |
| For commercially contracted studies |
For non-commercial studies |
Three pre-signed copies of clinical trial agreement - to include form of indemnity & financial details |
Evidence of independent peer review (further information) |
(further information) |
Grant application and award letter (if applicable) |
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Study agreement (if applicable) |
| AND... |
| For studies involving a medicinal product (further information) |
Copy of MHRA approval letter OR evidence from the MHRA that a Clinical Trials Authorisation is not required |
If the Trust is sponsor for the study, a copy of the Clinical Trials Authorisation |
| AND... |
| When non-NHS employees are involved in the research |
Research Passport application form (further information) and accompanying documentation where applicable |
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Registration of Clinical Trials
"In 2004, the International Committee of Medical Journal Editors (ICMJE) gave notice that it will consider a clinical trial for publication only if it has been registered in an appropriate registry. The ICMJE confirmed in May 2005 that this policy takes effect for new clinical trials on 1 July 2005 and for ongoing trials on 13 September 2005."
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