Guideline on the application of the General Data Protection Regulation (GDPR) and template for drafting additional information (addendum) for study participants in line with GDPR (v1.0, 26.09.18). The guideline and the template-addendum is available in German, French and Italian
Protocol templates: Further use without informed consent (Art. 34). New versions (v2.2, 21.08.2018) in DE, FR, IT.
Modified title of chapter 8 in conformity with the legal wording
There is a new SAE template for studies with medical devices for the notification of SAE and to report device deficiencies. That is, device deficiencies, like SAE, must be submitted to the EC via the safety form in BASEC on screen 3 ‘SAE/SE’ (see picture).
The form was originally developed by Swissmedic, but also contains sections relevant to the ECs, like the BASEC ID Nr, Lead-EC and local ECs, applicant ‘s contact details, etc.
The SAE template is available in German, French and English. The version in English can be downloaded from BASEC directly.
The security feature reCAPTCHA has been activated for the creation of new accounts. The additional question the user must answer when they first create a new account is for preventing automated accounts creation. We are in contact with Optimy for adding this security feature to all regular login in Front-end also.
There’s now a doc table in the safety-form. As for the other forms, you find it in the Tab “Docs”. By default it’s sorted by category (SAE/DSUR/…) which follows the screen-order, but the table can also be sorted by submission date with a click on the rightmost column.
Exports from BASEC are still suspended for the moment. The problem will definitively be resolved once we have migrated to the new server during the course of 4Q18.
Because of that, RoPS was not updated as scheduled during the Summer. The next update is planned for December.
Unfortunately, there are still cases where the manual trigger for the transfer of a project from BASEC to SNCTP2 is not done correctly. The steps to trigger the transfer must be made in the exact sequence as indicated in this FAQ. A switch of steps results in the project not being transferred.
Also, remember that if after the initial study approval and transfer of the study into SNCTP a researcher updates the information in screen 4 (for example if only a site is closed but the study continues), the transfer of the new data must be actively triggered by going through a status change again.
The training in Prangins on November 22, in French, for members of the ethics committees and staff of the scientific secretariats has also been recognized by the SIWF-ISFM / FMH with 4 credits point. The updated agenda of the training is available from the webpage.
That’s it !