Short BASEC status update
this is a short update about the most recent changes in BASEC.
The main form has been redesigned according to the discussions of the last months and the collected feedback from users. It's live since August 21th, 07:30h.
Herebelow important things and implications you need to know:
- Great care has been taken to preserve data from already submitted projects. Yet, if you or an applicant still miss anything, please contact swissethics. We created PDFs of all existing projects prior to the modifications. At the moment these PDFs are stored in the internal file server of swissethics. They will be uploaded to the matching projects (and eventually show up in the Documents Manager of each project).
- Some modified sections will need action by Applicants during the next update of a project that was submitted before the form modification:
- Radiation: If an applicant has chosen the Option "Yes, but the study is only using ionising radiation for imaging/control purposes", s/he will have to re-answer follow-up questions. It wasn't possible to do it in another way, because the section wasn't correct before. It's now based on bilateral discussions with the BAG, and the BAG has approved it. There is a new document, Cat. 40.: "Pharmaceutical Quality Dossier for non-IMP (Investigational Medicinal Product) ", that might be asked for, after certain answers to the new questions.
We made backups of the former radiation documents, if you or an applicant need any of them, please contact swissethics.
- SNCTP: following a request from BAG, there's now a section for "keywords" and one for "rare disease". We asked the BAG to retrospectively classify already transferred projects, but it wasn't possible to get a classification for all of them. This means: in some cases, an applicant might need to fill in keywords / rare disease during an update, even if the project was already in the SNCTP.
- The question 'type of trial' was redesigned: There's no more a subquestion for 'further use', all 5 options are now on the same level: Clinical trial, Involving persons, Further use data/material, deceased persons, embryos.
Unfortunately, this had a side-effect:
- Currently, the column for 'type of trial' in lists of projects remains empty for further use projects submitted before August 18th.
- In the decision letter the classification checkboxes for data/material, deceased, embryos remain unchecked for further use projects.
- Michael is currently working to solve these problems - they will be resolved asap.
- For "clinical" and "research involving persons" it's now possible to indicate that it's a combined project, together with research on data/material. If this checkbox is checked (below type of trial), the applicant has to also answer the further use-questionnaire on Screen 3. (This is the only configuration where a user has to enter more information than in the previous version of the form.)
Last but not least, a big THANK YOU to all of you who have contributed with ideas, comments, corrections and testing to produce the new form and an even bigger THANK YOU to Michael, who worked day and night the last days to make the transition a success!
That's it !