What is it? Why is it important?
Based on the HRA law, relevant study documents must initially be submitted and approved by health authorities prior to being implemented in a study.
Applicable health authorities include:
- Ethics Committee (EC)
- Federal Office of Public Health (FOPH)
Extend of documents that must be submitted, including which health authority to submit to is based on the:
- Respective ordinance that applies to the study (e.g. ClinO, ClinO-MD, HRO)
- Study type (e.g. interventional versus observational studies, transplantation products, investigations involving ionising radiation)
- Study risk-category (e.g. A,B,C, with A having a low risk and C a high risk)
- Study set-up (e.g. multi- versus mono-centre studies)
EC*: All studies and their respective documents must be submitted and approved by EC, irrespective of ordinance, study type, study risk, and study set-up
Swissmedic: The following studies and their respective documents must be submitted and approved by Swissmedic:
- ClinO studies with risk-category B and C
- ClinO-MD studies with risk-category C
- Therapeutic and transplant products with risk-category B and C
- Studies with gene therapy, genetically modified pathogenic organism, and ionising radiation, with risk-category B and C
FOPH: In addition to Swissmedic the following studies must submit their documents to the FOPH:
- ClinO studies with:
- Gene therapy, genetically modified pathogenic organisms
- Transplantation of human organs, tissues and cells, and with risk-category B and C
- Studies with radiation sources exceeding 5mSv/year for participants, and with risk-category C
- HRO studies with radiation sources exceeding 5mSv/year for participants
What do I need to do?
Based on your study, make yourself familiar with which documents must be submitted to EC, RA (Swissmedic), and FOPH respectively.
- Study documents are uploaded on BASEC, the EC electronic submission portal
- Create a personalized BASEC login
- Upload all EC required documents (e.g. also listed in the ClinO, ClinO-MD, HRO ordinances)
- Pepare a CTA dossier
- Include documents according to given guidelines
FOPH additional submission:
- Upload all FOPH required documents as listed in the ClinO and HRO ordinances
For more information refer to Ethics & Law in this Study Guide.
When submitting to health authorities, submission to EC, Swissmedic and FOPH, can be done concurrently, as applicable.
Based on the law, each study is risk-categorized (e.g. risk category A, B, C). Access KOFAM that provides assistance in the risk categorisation of human studies.
Upon submission remember to register your study.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
Swissethics – see in particular
- Instruction for EC submission
Swissmedic – see in particular
- Guidelines for CTA dossiers submitted
BASEC – see in particular
- List of required documents for submission
KOFAM is the SNCTP portal for human research for study registration and risk categorisation
BAG – see in particular
- Transplantationsgesetz, SR 810.21
- Transplantationsverordnung, SR 810.211
- Xenotransplantationsverordnung, SR 810.213
ClinicalTrials.gov – see in particular
- Submit Studies
OrgO-HRA – see in particular article
- Ch. 1 Research and EC
- Ch. 2 Coordination Office
HRA – see in particular article
- Art. 2 Scope of the Law
ClinO – see in particular article and annexes
- Art. 23 Coordination and information in authorisation procedures
- Annex 3 Application documents to EC
- Annex 4 Application documents to Swissmedic and FOPH
- Annex 3, Chapter 6 FOPH application for studies involving radiation sources
ClinO-MD – see in particular annex
- Annex 1 Application documents for study approval
HRO – see in particular articles and annex
- Art. 23 Assessment, notification and reporting on the use of radiation sources
- Annex 2 Based on study application documents to be submitted to the responsible EC and FOPH