Joint Newsletter with The Coordination Office for Human Research (kofam)
Gemeinsamer Newsletter mit der Koordinationsstelle Forschung am Menschen (kofam)
Bulletin conjoint avec l’organe de coordination de la recherche sur l’être humain (kofam)
Newsletter comune con l’organo di coordinamento sulla ricerca umana (kofam)

 

Topic 1: Improvements in the Swiss National Clinical Trials Portal (SNCTP)
Topic 2:
Updating approved clinical studies with the WHO primary clinical trial registry number

 

Topic 1:

Improvements in the Swiss National Clinical Trials Portal (SNCTP)

Pursuant to the Human Research Act all clinical trials in Switzerland have to be published in the Swiss National Clinical Trials Portal (SNCTP). With the release 2.0 the portal has been further improved and supplemented with new functions. The portal may be accessed from the website of the Portal for Human Research (www.kofam.ch).

Since 2014 all clinical trials in Switzerland authorised by an ethics committee have been published in the SNCTP. The study portal thus provides an important contribution to transparency in human research. At present information on approximately 43 000 studies from Switzerland and neighbouring countries can be inspected.

The SNCTP and the BASEC/SNCTP interface are continuously updated. The release 2.0 includes amongst other things the following improvements:

Improved search function:

  • Keywords enable new filtering possibilities according to diseases and to rare (orphan) diseases
  • Various error fixes resulting in improved search results

Simplified user guidance for the import of data from BASEC:

  • Automatic transfer of updated study information from BASEC into SNCTP: The manual consent to the “Agreement on automatic data transfer” in the context of the BASEC submission process screen 4 is now only required for the initial entry of a new study. Studies already registered in the SNCTP which are updated via BASEC no longer need the “Agreement on automatic data transfer” to be confirmed.

Manual entry and updates to the registration of clinical studies that had been authorised before the introduction of BASEC (pre-BASEC Studies):

  • Phase I studies do not have to be registered before the commencement of the study, but rather must be registered in the SNCTP within one year of completion. Completed Phase I studies that had been submitted before the launch of BASEC (1.1.2016), and are not yet registered in the SNCTP, must now be manually entered (registered) into the SNCTP.
  • Clinical studies that were authorised and registered in the SNCTP between the entry into force of the HRA (1.1.2014) and the introduction of BASEC (1.1.2016), and for which authorised amendments exist, likewise require manual updating.
  • The required information for manual entry or updating pre-BASEC studies must be provided by the study sponsor to the FOPH, by means of a Word form. The Word form is also available in BASEC (screen 1, pre-BASEC research project). We request those responsible to provide the required information in due course via email (snctp@bag.admin.ch) to the FOPH using the mentioned form.

Further improvements will be undertaken in due course. As before, users have the possibility to provide their feedback on the functionality of the portal.

 

Topic 2:

Updating approved clinical studies with the WHO primary clinical trial registry number

The SNCTP is a secondary registry that draws its information from two sources:

  • The WHO International Clinical Trials Registry Platform (ICTRP), a secondary registry which aggregates information in English language from all primary clinical trial registries (e.g. clinicaltrials.gov or EudraCT).
  • The registration database of the Swiss ethics committees (BASEC), which provides local and lay information in a national language

In the SNCTP, the data from both databases are joined using the external (primary) identification number assigned by the primary registry upon first registration. This external identification number should be entered into BASEC during trial application. If this number is not entered during the first BASEC application, it must be entered as soon as available in order to allow correct linking of the ICTRP and BASEC data entries in SNCTP. Currently, there are a number of approved clinical trials for which the external identification number has not yet been entered. We urge the respective sponsor representatives to fill in this information in due course.

To fill in a missing external identification number, please follow the steps below:

  1. Identify the external identification ID. This is the unique ID assigned by the primary clinical trial register you used for registration of your study (e.g. clinicaltrials.gov, EudraCT). The number has the following format:
    • clincialtrials.gov: NCTXXXXXXXX, e.g. NCT01234567
    • EudraCT: EUCTRXXXX-XXXXXX-XX-XX e.g. EUCTR2012-000737-40
    • If IDs from other primary registry are used, please make sure to obtain the correct format
  2. Log-in to your BASEC account
  3. Click on “Manage my applications”
  4. Identify and click on the BASEC study needing registration of the external identification ID
  5. Navigate to screen 4 (SNCTP)
  6. Choose the appropriate primary registry and enter the respective primary registry ID in the field “external identification number (ID)”
  7. Click on “I agree to the automatic transfer of the relevant data into the SNCTP”
  8. Navigate to screen 14 (submission summary)
  9. Under “Submission details and comments”, paragraph “Notifications”, click on “changes to SNCTP information”
  10. Click on “Submit” at the bottom of the page.
  11. Your updated study is now pending for approval at the ethics committee
  12. After the study update has been approved by the ethics committee, the updated information is transferred to the SNCTP
  13. To check whether updating the primary registry ID has worked and the information from the primary registry and BASEC has been linked correctly, go to the SNCTP, search for your trial. Linking has worked correctly if the SNCTP displays both the primary registry number (e.g. the NCT number) and the SNCTP number in the trial header.

NB:
If your clinical study is a pre-BASEC-study, please use this form to communicate the external identification number to the FOPH, who will update the SNTCP accordingly.

 

That’s it!