As previously announced, the submission form “Research Project Application Form” has been simplified (questions and fields have been removed) and improved (dependencies of which questions to show based on form input), and it is again available to the BASEC-users, according to the original plan.
Brief summary of major changes:
It is now possible to indicate if a “clinical trial” or “research involving persons but not a clinical trial” is a combined research project with “Further use of health-related personal data and/or biological material”. The questions then adapt automatically to this ‘new’ type of trial.
The section on projects involving ionizing radiation and its array of questions have been completely rewritten and simplified. For new research project only, if the research is using “ionising radiation for imaging/control purposes” and “conducted with a radiopharmaceutical / medical device emitting ionising radiation which is not authorised in Switzerland”, a Pharmaceutical Quality Dossier (PQD) for non-IMP will now need to be upload on screen 6.
In order to improve the ‘search’ function for clinical trials in the newly release SNCTP-2, we have added a new section on screen 4 (SNCTP) for "keywords" and one for "rare disease". The vast majority of ongoing trials have been classify retrospectively but it was not possible to get a classification for all of them. This means that in some few cases, you might be asked to fill in the “keywords” and “rare disease” fields, next time you update your project in BASEC.
An improved PDF-layout of the submitted research projects will be released shortly.
That's it !