swissethics Newsletter Nr 

swissethics Newsletter Nr 2017/10

 

Ihnen und Ihren Angehörigen wünschen wir eine fröhliche Weihnachtszeit und einen guten Rutsch in ein neues, erfolgreiches Jahr.

Nous vous souhaitons, ainsi qu'à vos proches, de Joyeuses Fêtes de Noël et une bonne année.

Auguriamo a voi e ai vostri familiari una serena festa di Natale e un felice Anno Nuovo.

 

Quick links

Webpage swissethics

New documents
New versions
Position papers / guidelines

BASEC

BASEC-SNCTP
New features
New PDF form for “Research Project Application Form”
Performance

Decision letter

 

Webpage swissethics

New document

The slides of the presentations of the trainings for EC members held on 21. November in Zürich and on 29. November in Prangins are now available on the webpage at Home > news/Aktuell > presentations.

New versions

Serious Events (SE) (v1.2):  Form for research projects not involving clinical trials (HRO). The form has been slightly modified to indicate the full address and contact of the research site, and the box ‘evaluation of the event’ redesigned and renamed for an improved clarity.

Position papers / Guidelines

Guideline on the use of electronic informed consent (eIC) in clinical trials. The new guideline is available in English (v1.0). The guideline was reviewed by swissmedic, interpharma and the SCTO.

Guideline on the retention period of biological material and personal data of further use projects without the informed consent of the persons concerned (according to Art. 34 HRA). The new guideline is available in German, French and Italian, (v1.0, 10.12.2017).

BASEC

BASEC-SNCTP

The FOPH has unilaterally decided to publish also the clinical trials in BASEC that are missing the ID number of a WHO-primary registry or the ID number of the clinicaltrials.gov registry, i.e. the ID number must no longer be entered in BASEC by the applicant for the project to show up in SNCTP. The consequences of the decision by the FOPH is that a match between that data imported from BASEC to SNCTP and the data imported from a WHO-primary registry or from the clinicaltrials.gov registry is not possible, and this leads to projects showing up twice in SNCTP.

swissethics disagrees with the decision and will confront the FOPH on this matter in January.

New features

A checkbox has been added below the comment field of the task to indicate that the task has been completed. By clicking on «Mark this as done» and on «Post this comment», which acts as a «save» button, the task is marked as such. «Post this comment». Obviously, you have to write a comment, if you want to check the task off on this screen.

New PDF form for ‘Research Project Application Form’

The first release version for an improved PDF-version of the projects is now available in backend through the link «PDF» on top of a project, then by selecting «New Base Form» in the Dropdown list and then «Generate PDF».

Early next year the PDFs will be downloadable by a single click from the «Overview» section, and a bit later it will also replace the current PDF-layout that applicants can download from the frontend.

The new PDF-version can be used by the EC members as an ‘offline’ reference of the projects under EC review.

Performance

The work with Optimy to improve the overall performance of BASEC is ongoing.
The first set of investments and changes to the system should already have brought much faster loading time for “Tasks”, “Messaging” and “DocumentsManager”. These parts/sections should now load immediately after a project is visible on screen (no additional waiting time). Furthermore, additional database optimisations were implemented to improve overall performance/responsivity under heavy load.

More investments and changes to the system will be done in January/February 2018.

Decision letter

In multicenter research projects, to avoid misunderstanding for the applicant when a local site is approved but not yet the main site, the field box “Die Bewilligung kann noch nicht erteilt werden / En l'état, l'autorisation ne peut pas être accordée / Il progetto non può ancora essere autorizzato“ must be ticked for the local site.

 

That's it for 2017, see you in 2018 !