swissethics Newsletter Nr 2017/3
 

Quick links

Communication
1. Decision letter
2. GCP certificates
3. Meetings

Webpage swissethics
1. New Versions

BASEC
1. New features


Communication:

1. Decision letter:

The following note has been added to the decision letter in the paragraph ‘responsibility of the applicant’:

”The competent ethics committee verifies the Patient Informed Consent as part of the authorization procedure, in one of the official languages German, French or Italian. The ethics committee only acknowledges receipt of Patient Informed Consent written in non-official languages. The sponsor or the project lead is responsible for the accurate translation.”

Reminder: Contact Michael Tüller if you need a local customization of the decision letter, like changes to the font /character sizes / address position etc.

 

2. GCP certificates:

The following note has been added on the list of GCP course providers. You can refer to the note, in case an investigators submit an old GCP certificate.

”swissethics strongly recommends that the knowledge is maintained by regular research activity, e.g. by conducting clinical trials, attending continuing education related to research or GCP refresher courses, being exposed to GCP inspection etc. The Ethics Committees can request the researchers to re-take a GCP course, if the Ethics Committees consider the knowledge has not been maintained. ”

3 Meetings:

  • BASEC steering team meeting, Bern, 1-June 2017
  • Admin. secretary meeting, Bern, 20-June 2017
  • Scientific secretary meeting, Bern, 12-October 2017
  • Training for EC members (in German), Zurich, 21-November 2017
  • Training for EC members (in French), Nyon, 29-November 2017

 

Webpage swissethics:

1. New versions:

  • New version (v2.0): Template for the notification of the end of a clinical trial or of a research project and in case of discontinuation or interruption (in English)
  • New version (v5.0, release date 01.05.2017, effective date 01.09.2017): Template for the patient information and declaration of consent according to ClinO, in DE, FR and IT:
    • Template für die Erstellung einer schriftlichen Studieninformation für klinische Versuche gemäss HFG/KlinV
    • Modèle pour l’élaboration d’une feuille d’information écrite pour les études cliniques conformément à la LRH / l‘OClin
    • Modello per redigere un documento informativo per studi clinici secondo LRUm/OSRUm
  • New version (v2.0, release date 01.05.2017, effective date 01.09.2017): Template for the patient information and declaration of consent according to HRO chapter 2, in DE, FR and IT:
    • Template für die Erstellung einer schriftlichen Studieninformation für Projekte unter Einbezug von Personen gemäss HFG/HFV 2. Kapitel
    • Modèle pour l’élaboration d’une feuille d’information écrite pour les études impliquant des personnes conformément à la LRH / l‘ORH Chapitre 2
    • Modello per redigere un documento informativo per studi con persone secondo LRUm/ORUm Capitolo 2

The main changes to the templates ClinO and HRO includes:

  • added the sentence in paragraph ‘compensation’ in black: ‘Es entstehen Ihnen oder Ihrer Krankenkasse keine Kosten durch die Teilnahme’; ‘Votre participation n’aura aucune conséquence financière pour vous ou votre assurance maladie’; ‘La partecipazione allo studio non causerà costi né a Lei né alla sua assicurazione malattia’.
  • added email address to ‘contact’, numbered lines, and other minor changes.
  • ClinO only: amended paragraph ‘liability’ (‘Haftung’, ‘réparation des dommages subis’, ‘responsabilità’).
  • Minor changes: typos, changes done to harmonize the ICFs between languages, etc.
  • Added the ‘history log’ on page 1.

The use of the new ICF templates is mandatory 4 months after its publication, i.e. 01.09.2017.

 

BASEC:

1. New features:

Back-end:

The Overview-Section of the Local-Form in the Backend (Projects beginning with L_) now also displays the centres and the billing address for the local EC. This data is pulled from the linked main project. It only works for “real” BASEC-projects (not for linked PB-projects). The “algorithm” goes through all the possibilities that there exist for the local billing address and displays what it has found.

It’s important to fill in your own EC when creating a new L_ form. The field "Local Ethics Committee” should not be empty, because the code needs this information to pull the correct data from the linked project.

See the screenshot with an example: It’s the L-form of EKOS, therefore the 3 existing centres for EKOS are pulled from the linked main form, billing should be to the same address as for the main project.

 

That's it!