swissethics Newsletter Nr 2017/4
 

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Communication
1. Updated “Guidance for researchers regarding Research Ethics and GCP Training”
2. BASEC-SNCTP interface


Communication:

1. Updated “Guidance for researchers regarding Research Ethics and GCP Training”:

The document “Guidance for researchers regarding Research Ethics and GCP Training” (new version v3.0, 9.5.2017) on the swissethics webpage under ‘education and training’ has been updated with the following text:

Note: As of 1 May 2017, the integrated addendum to the GCP guidelines E6(R2) is applicable in Switzerland. The researchers in possess of a GCP certificate recognized by swissethics, but who have not taken a GCP course with the integrated addendum E6(R2), are requested to study the new guidelines in addition. A version of the integrated addendum E6(R2) – with the changes highlighted – is available on www.ich.org. Direct link to the document here.

 

2. BASEC-SNCP interface

Starting today, research projects submitted through BASEC will be transferred into the Swiss National Clinical Trials Portal (SNCTP) via the new electronic interface. The transfer is triggered automatically with status changes (Project approved and a few other, see linked FAQ-article below).

In order to show up on kofam.ch a project must meet the following criteria: 

1) the project is a clinical trial
2) the applicant has agreed to the ‘automatic transfer’ on screen 4 in BASEC
3) the clinical trial is registered in a primary WHO-register and the corresponding values on screen 4 in BASEC are entered correctly
4) the EC has set the final decision in EC Data > Response times to “approved”

Please read the following FAQ-article to get knowledgeable with the process and your role and responsibilities, we tried to anticipate questions you might have: http://swissethics.ch/basec_help/knowledgebase.php?article=18

That's it!