swissethics Newsletter Nr 2017/9
 
 

Quick links

Webpage swissethics

Templates
New documents

New versions
Position papers / guidelines

Concept for the basic and further training of EC members

BASEC

BASEC-SNCTP: reminder on how to trigger a project transfer from BASEC to SNCTP2
BASEC-SNCTP: de-publishing feature
BASEC Back-end: Messaging: ! attention !
BASEC Back-end: User rights for EC members
BASEC Data Cleaning: ‘Ressortforschung’ HRA Evaluation

From the IT wonder box

 

Webpage swissethics

Templates

New document

SAE Form (v1.0): The use of this template, for the notification of serious adverse events for research project that fall within the scope of ClinO, is not mandatory. As it is the case for the SE form, it should be used by those research centers that do not have any equivalent SAE form.

New versions

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Position papers / Guidelines

Technische Assistenzsysteme / Dispositifs d’assistance (v1.1, 20.09.2017), in German and French. The guideline helps the researcher to define, during the early development phases of a ‘technical assistance system’, which investigations/tests fall within the definition of research in the HRA.

Guideline for conducting research with healthy children and adolescents (1st edition 2017), in German and French. The guideline is also available in printed form and can be requested by email at info@swissethics.ch

Leitfaden Bedenkfrist / Lignes directrice en matière de délai de réflexion (v1.0, 10.11.2017), in German and French. The guideline answers the questions on the period of reflection required between giving the information to a potential study participant and obtaining his/her written consent, and on which legal and ethical requirements do the ECs base their decisions on?

Concept for the basic and further training of EC members

Commissioned by the FOPH, swissethics has developed a concept for the basic training of new EC members and for the further training of the experienced ones.

The fulfilment of the obligation of the EC members to attend basic training and regularly undergo further training (Art. 2, OrgO-HRA) is recorded in a national register kept by swissethics. This comes into force on 1st January 2018. More detailed information about the register will follow early 2018.

A selection of recommended literature for EC members is made available on swissethics.ch / education training, with publications in German, French and English.

 

BASEC

BASEC-SNCTP: reminder on how to trigger a project transfer from BASEC to SNCTP2

We remind you that the so called ‚automatic transfer’ of a clinical trial from BASEC to SNCTP2 must actually be triggered manually by changing the status of the project in Back-end. That is: if after the initial study approval and transfer of the study into SNCTP a researcher updates the information in screen 4, the transfer of the new data must be actively triggered by going through a status change. The link to the corresponding FAQ is here.

BASEC-SNCTP: de-publishing feature

If you transfer a clinical trial from BASEC to SNCTP2 by mistake, you can de-publish it from the BASEC Back-end. The FAQ on how to de-publish and re-publish a clinical trial in SNCTP2 is here (last bullet point). You can always re-publish the trial at a later stage, as described in the FAQ.

Messaging: ! attention !

Please take good note that if you remove a participant an ongoing conversation s/he loses access to all previous messages of that conversation. If you give this person access again later on, s/he will also get access to those messages in which s/he was "locked out".

If you exclude someone from a conversation, because you do not want him/her to know what is being discussed, it can get embarrassing under certain circumstances if you grant him/her again later on access to the same conversation.

User rights in Back-end for EC members

At the scientific secretary meeting of October 12, it was decided to redefine the user rights in Back-end of the EC members. No EC member will lose the current rights, some EC member will gain some new rights (e.g. use of tasks): see point 9 of the minutes of meeting for the details. The new user rights will be activated on Monday November 27.

BASEC Data Cleaning: ‘Ressortforschung’ HRA Evaluation

As most of you already know, the ECs and swissethics are actively involved in a series of projects for the evaluation of the HRA and its ordinances. One of the projects requires the analysis of the data in BASEC. A pre-analysis on the quality the data, entered manually in Back-end, has identified errors and missing data, which need to be corrected and completed. We will soon provide the Heads of the scientific secretaries with a list of the projects concerned. Critical errors and missing data will be highlighted to help you in the cleaning process.

From the IT wonder box

If you need to search a text or a document within a Browser-Window and there is no integrated Search function, just hit ctrl+f while on the Template page and search in the Browser: this searches the text of the actual Browser-Window.

There is also always the possibility to use Googles search syntax: Type your search terms in the google search box then a space and then e.g.  “site:swissethics.ch”. This limits the Goggle search to data from swissethics.ch.

 

That's it!