Registration in the Swiss Clinical Trials Portal (HumRes)
The Federal Act on Research involving Human Beings (HRA) and the Ordinances on Clinical Trials in Human Research (ClinO) and on Clinical Trials of Medical Devices (ClinO-MD) provide that research projects must be registered and published in a primary registry recognised by the Wordl Health Organisation (WHO) or in the registry of the U.S National Library of Medicine as well as in the Swiss Clinical Trials Portal Human Research Switzerland (HumRes).
The sponsor enters the data specified in Annex 5 numbers 2.1-2.9 in screen 4. HumRes in BASEC. The sponsor is responsible for the accuracy and completeness of the data entered (article 66 ClinO)!
BASEC allows the automatic transfer of the data to "HumRes".
A project is transferred from BASEC to "HumRes" if the following conditions are met:
- The project is a clinical trial as defined by the Ordinance on Clinical Trials in Human Research (ClinO), respectively by the Ordinance on Clinial Trials of Medical Devices (ClinO-MD);
- The project must be approved by the competent Ethics Committee and by Swissmedic (for clinical trials of category B and C) and/or by the Federal Office of Public Health (FOPH, for clinical trials involving radiation sources, gene therapy, clinical trials of genetically modified or pathogenic organisms, and clinical trials of the transplantation of human organs, tissues and cells).
The sponsor should enter the data in the Swiss national language in which recruitment is planned. The data must be entered in the version approved by the responsible Ethics Committee.
The data must be regularly updated. Changes made to Screen 4 “HumRes” are also automatically transferred to "HumRes".
Registartion must take place before the conduct of the clinical trial, and within six months afer approval has been granted for it*.
*Exception: For Phase I clinical trials in which the medicinal product under investigation is administered exclusively to adults, the data specified in Annex 5 number 3.1 ClinO may initially be excluded from entry; it must however be entered and published at the latest within 30 months after completion or early terminiation of the clinical trial.
Publication of trial results
For the purpose of publication of the trials results in "HumRes" (article 65a ClinO), the sponsor must enter a lay summary of the trial results in screen 6. Lead EC, 52. Final report, in BASEC.
The entry must be made at least in those national languages of Switzerland in which persons were recruited.
The sponsor must enter the lay summary of th trial results within a year after completion or premature termination of the clinical trial.
For Phase I clinical trials in which the medicinal product under investigation is administered exclusively to adults, publication of the trial results must take place at the latest within 30 months after completion or early terminiation of the clinical trial.
If publication in accordance with paragraphs 1 and 2 article 65 ClinO is not possible within the specified period for scientific reasons, the sponsor must explain this in the applicatation documents and indicate when publication will take place.
The sponsor is responsible for the accuracy and completeness of the data entered.
Registration and update of pre-BASEC projects
Contact swissethics at info@swissethics.ch if your clinical trial is not registered in HumRes and was submitted to the Ethics Committee before the introduction of BASEC (1.1.2016).