Requests

 

Requests for advising from the ethics committee can be submitted at any time.

Requests, that must be orally advised according to the constitution, should be submitted no later than two weeks before the next meeting date.

According to the constitution this applies to studies having to do with

  • AMG (in multicentric studies as the leading Ethics Committee or in monocentric studies)
  • MPG (in multicentric studies as the leading Ethics Committee or in monocentric studies)
  • RöV
  • StrlSchV

Please only use the documents provided for this purpose.

The original text files or, if pdf files were used, pdf files are accepted in the print version (but not scanned pdf files=, so that the files can be searched for key words using the search command.

Here you can find additional helpful tips and documents on the following topics:
General tips for individuals submitting a requst, amendments, definitions, genetic investigations, mistakes/deficiencies, minors, individuals unable to give consent, SUSARs, insurance, advertising

Important documents for registering clinical studies and the number of documents to submit are available in the download section below.

On the following pages you can find information and downloads about the request documents:

Anträge nach Arzneimittelgesetz (AMG)

Anträge nach Medizinproduktegesetz (MPG)

Requests for other studies

1. Studien nach RöV/StrlSchV

2. Epidemiological Studies

3. Studies on Endogenous Material

4. Other Studies

5. Case Series/Post Market Studies/NIS

fMRI Studies

Request an Opinion