swissethics webpage: New version
The swissethics template for writing a protocol for clinical trials has been updated and just published on swissethics.ch (new version 3.3, dated 28.05.2018).
The changes include the addition of a new chapter 10.4 'Assessment, notification and reporting on the use of radiation sources' as per ClinO art. 44, and the alignment of the definition of SAE for Medical devices studies with the european regulation on medical devices 2017/45 art 58.
Optimy has informed us that BASEC Back-end does not work properly with the web brower Safari and tablets. If someone uses the Mac/iPad to access BASEC Back-end, he/she should install another web browers. The problem might get solved when Optimy releases a major upgrade to the system later this year.