Public disclosure study results and upload safety reports webportal ToetsingOnline

As a result of two amendments to the Medical Research Involving Human Subjects Act (WMO), the webportal ToetsingOnline and the ABR form are adapted. It concerns the change in article 10 (Dutch) WMO on October 1, about the reporting of serious adverse events and the change in a subsection of article 3, which will come into force as of December, 15 2015. A subsection of article 3 stipulates that study results have to be made public by the CCMO, unless the sponsor has object to this. The public disclosure will be registered in the webportal ToetsingOnline through the ABR form. If no objection has been made by the sponsor, the study results are made public in the CCMO register 15 days after they are uploaded in ToetsingOnline.

ABR-form

An additional field has been entered in the ABR form on the public disclosure of study results (section A2) including the procedure to object to this public disclosure. See ABR form, version December 15, 2015 and explanatory notes.

ToetsingOnline

As of December 15 2015, it is possible to upload the following documents in ToetsingOnline:

  • A pdf of a SAE report can be uploaded at question B1 of the eSAE form, eg CIOMS report;
  • A periodic line-listing SAEs;
  • A periodic line-listing  SUSARs;
  • A annual safety report or DSUR;
  • A pdf with study results within one year after the end of the study. This concerns a scientific summary and a lay person’s summary of the study results. It is also possible to refer to a public website where the results have been published.

All these uploaded documents will be transfered via a secured SSL interface and multiple files can be uploaded per section. See also the annex to the manual ToetsingOnline.

CCMO-register

The public disclosure of study results in the CCMO register applies only for new clinical trial application submitted as of December 15, 2015 and for which the sponsor has not object to this. For all other research dossiers, the study results can be uploaded in ToetsingOnline and will only be made public if a written request is submitted to the CCMO by the sponsor. It will be visible in the CCMO register for which research dossiers study results are publicly available.