Clinical Protocol template for Investigator initiated trials (IIT), version 3.2, 17.01.2018 in English:
The template was updated to comply with MEDDEV 2.7/3 rev. 3. Reporting obligations for Cat. A clinical trials were updated and corrected.
Notification and reporting to the ethics committee for clinical trials (ClinO) and for research projects not involving clinical trials (HRO) v3.0, 19.01.2018, in German, French, Italian and English:
The text was updated to comply with the recent changes in the Ordinances ClinO and HRO (see Newsletter 2018/01), to describe the process of notification and reporting electronically through BASEC, and for multicentric projects.
Leitfaden Technische Assistenzsysteme / Lignes directrices sur les dispositifs d’assistance: revised version 2.0 in German and French
Information sheet: Clinical Trials with foodstuffs and dietary supplements: revised version 2.0, in English
It is now possible to send automatic ‘Silent Acknowledgment’ email from within BASEC together with the status change. Start using this functionality and let us know if there are any problems.
Template decision letter for amendments:
The new templates for the decision letter for amendments is now available in BASEC and works the same as with the main decision letter: To get the contents please use the .html template.
For headers/footers and address, use the .docx template from the decision_letter.
The templates decision letter for amendments are named as follows:
Please let us know if there are any errors or would like anything to be modified.
The CTU Basel will perform a BASEC training on Feb. 15 and Mar. 14. They are not supposed to submit any test projects, but just in case this would happen by mistake, please let us know and we will delete them. The students will name the protocol ‘exercice’.
Please keep continuing filling in the empty fields and correcting the wrong entries in BASEC by Feb. 23 latest. We will then do a last quality check before providing you with the final data from BASEC for your annual activity report.
The fields that must be completed and corrected are the following:
- Date 1st reaction
- Date formally complete
- Date 1st decision
- Procedure 1st decision
- 1st decision
- Date final decision
- Final decision
The speed of the system has been increased further during January. The “Overview” section and the docs-table should now load very fast.
and a drawback
“Unfortunately Optimy introduced a change to the versioning that brought problems:
The compare-process is slower than before, sometimes the comparison exits prematurely with an error message and the coloring to mark changes is reversed (red/green).
For the last point there is a workaround: In the top dropdown select the old version and in the dropdown the newer version that you want to compare.
We are in contact with Optimy and pressing for a fast solution. We are sorry if your daily work gets delayed by this.