How to Submit a Research Proposal to IMDECThe research sponsor or the investigator submits a copy of all required documentation in English or German to IMDEC by mail, fax or e-mail. The required documentation includes, but is not necessarily limited to:
- A short written request for IRB review
- Research protocol or clinical investigation plan
- Informed-consent documentation
- Investigator’s brochure (if applicable)
- Principal investigator’s CV
- List of proposed study centers
- Verification of insurance coverage and/or copy of CE mark
- Case report forms
Please refer to Section V of IMDEC’s SOPs (Initial Processing of Research Submissions) to determine whether any additional submission requirements apply.
The IRB staff will check each submission to determine whether all of the appropriate documents have been made available. This initial check offers no guarantee that all incomplete submissions will be identified as such. Submission completeness can only be conclusively established by the members at a convened meeting.
If the submission appears to be incomplete, the IRB staff will contact the sender to request the submission of any missing documents. Otherwise, the IRB staff will distribute the complete set of documents to the members who are slated to participate in the next convened meeting.
When submitting research proposals, please make sure to identify your documents by clearly specifying any appropriate titles, dates and code numbers. IMDEC will use your system of document identification when drafting its own documents.
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