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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.

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