The following clinical trials need manual entry of study information relevant to the SNCTP:
- Phase I studies do not have to be registered before the commencement of the study, but rather must be registered in the SNCTP within one year of completion. Completed Phase I studies that had been submitted before the launch of BASEC (1.1.2016), and are not yet registered in the SNCTP, must now be manually entered (registered) into the SNCTP.
- Clinical trials that were authorised and registered in the SNCTP between the entry into force of the HRA (1.1.2014) and the introduction of BASEC (1.1.2016), and for which authorised amendments exist, likewise require manual updating.
The required information for manual entry or updating pre-BASEC studies must be provided by the study sponsor to the FOPH, by means of a Word form available below. The Word form is also available in BASEC (screen 1, pre-BASEC research project). We request those responsible to provide the required information in due course via email (email@example.com) to the FOPH using the mentioned form.