Submission Types
The many types of human-subjects research (HSR) that IMDEC reviews include:
- Cosmetic product testing
- Dietary-supplement testing
- Post-market surveillance studies (e.g. medical-device performance evaluations as per MPDG § 47)
- Biospecimen collection studies (e.g. blood-draw studies)
- Retrospective clinical studies
- Psychological and sociological studies
- Patient-reported outcome studies
- Questionnaires
Submitting Your Research Proposal to IMDEC
The research sponsor or the investigator submits a copy of all required documentation in English or German to IMDEC by e-mail. The required documentation includes:
- A short written request for IRB review
- Research protocol or clinical investigation plan (with version number and date)
- Informed-consent documentation (with version number and date)
- Principal investigator’s or study manager’s CV
- Statement on product safety (if applicable)
- List of proposed study centers (if applicable)
- Verification of insurance coverage and/or copy of CE mark (if applicable)
- Case report forms (if applicable)
- Recruitment text (if applicable)
All documents are subject to a brief preliminary examination before being forwarding to the IRB members. Depending on the day of submission, the review process may take up to 8 days.