swissethics Newsletter Nr 2018/5

 

Quick links

Webpage swissethics
   New versions
   RoPS: Registry of ongoing Research Projects in Switzerland

BASEC Front-end
   Minor changes to the submission form

BASEC Back-end
   Decision letter for amendment – template

 

Webpage swissethics

New versions

New version (v4.0, 02.05.2018): Coding of trial subject accepted by swissethics / Storage of the subject identification code list: in German, French, Italian and English.

A paragraph with information about the safe storage of the subject identification code has been added to the previous publish document “Coding of trial subject accepted by swissethics (v3.0).

New versions (v1.1, 26.04.2018): ‘Research on and with children: Checklist’ (DE, FRITEN) & ‘Research on and with children: Guidelines for the provision of study information’ (DE, FR, IT, EN).

The following sentence has been added to both documents: ‘If it is considered appropriate, the polite form of address may be used in the written information for the adolescents aged 14 and over’.

RoPS: Registry of ongoing Research Projects in Switzerland

To promote transparency on the ongoing research, we had so far regularly published a PDF list of all ongoing research projects on swissethics.ch. Because a PDF list does not allow an easy and quick productive use of the data, Michael has now developed the web-based portal RoPS.

RoPS is a registry/data bank of all ongoing research projects in Switzerland. Through RoPS the users can query the databank with free texts or with predefined key terms, use the available filters to sort the lists, print the selections or export lists in .xlsx or .csv format, set display preferences for the data, and more.

Although the data in RoPS comes from BASEC, there is no direct link between the two systems.

RoPS is not intended to race against or even replace SNCTP2; indeed the detailed information on clinical trials from screen 4 in BASEC is not displayed in RoPS and the data in RoPS is updated quarterly only - although this might change in the future.

The portal can be accesses at https://ongoingprojects.swissethics.ch or through the link on swissethics.ch.

 

BASEC Front-end

Minor changes to the submission form

A pre-analysis of the data in BASEC, done in the framework of the HRA- assessment, has shown that a couple of questions on the submission form are not understood by the applicants as intended.

  • The question “Who initiated the project?” on screen 1 is not filled in correctly by the applicants. Thus we have added the explanatory text:

Indicate here who had the original idea for the research project (do not indicate here who is financing, conducting or leading the project)

  • Question on financing. The formulation “Approximate amount, rounded to CHF 1000” on screen 1 is misleading since it may be understood as “Kilofranken”. The amount entered in this field is indeed sometimes in KCHF and sometimes not. We have thus simplified the sentence and removed “to CHF 1000”.
  • The requirement rules for the two fields “Phase” and “First in men” have been modified: The question “First in men” now has to be answered for clinical projects of phase 1, phase 1/2 or “n/a”, that are of type “drugs” or “combination drugs/devices”.
    “First in men also has to be answered for clinical projects of type “medical devices” (but not phase question for these projects). All existing projects and drafts of projects were cleaned up to follow these rules; applicants should not have to enter anything for already existing projects.

 

BASEC Back-end

Decision letter for the amendments – template

In order to reduce the number of templates in Back-end, there is now only one template (amendment_letter.html) for the decision letter amendment. The template is programmed in such a way that it adapts itself to the requirements of the Lead-EC of the project and the documents table now only lists submitted documents from the latest update by the applicant. In case you still need to list other submitted documents, please copy/paste from the doc-table in the form or request a documents table by way of the template “doctable_DE.html”, “doctable_FR.html” or doctable_IT.html”.

A similar consolidation (only one template) will follow sometime later for the decision letter.

 

That’s it !