Overview of submission documents
On screen 6 of the submission form you are asked to upload all required and optional documents concerning your research project. (For multicentric projects, screens 7 to 13 will be open for you to provide local documents for the additional research sites).
The set of required documents depends on the type of your research project and on the appendices of the ordinances ClinO/HRO. When you open the upload screens, BASEC will evaluate your answers previously provided in screens 1 to 4. You will only be asked to upload documents that are relevant for your type of project.
Click here to see an overview of the questions that have an influence on the set of required documents.
An overview of all required documents for all types of studies (clinical trials, research projects with persons, and research projects of further use of health related personal data and/or biological material) is available on the swissethics.ch webpage in the section dedicated to BASEC (direct link here).
Additional notes on screen 6:
- Files are uploaded automatically after confirming the file selection.
- Documents labelled with an asterisk * are required. Documents labelled with an asterisk in parenthesis (*) are required if they exist.
- The participant information sheet and informed consent (ICF), the study protocol and the protocol amendments, must be submitted in Word or searchable PDF format. Scanned documents must be converted in searchable PDF with an OCR software (Optical Character Recognition) before uploading.