Ordinance of 20 September 2013 on Clinical Trials not on Medical Devices and Ordinance of 1 July 2020 on Clinical Trials with Medical Devices
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Abbreviation
:
ClinO and ClinO-MD
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Provision
:
Art. 67 ClinO and Art. 41 ClinO-MD
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Short description
:
Public access to information on clinical trials conducted in Switzerland
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Nature of the provision
:
Obligation to publish data
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Status
:
In force
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Sector
:
Health, research
Legal text :
1 Public access to information on clinical trials carried out in Switzerland shall be assured by remote access to one or more registers (portal).
2 The portal shall, in particular, allow:
a. linking of data from the additional federal database with data from the registers allowed under Article 64 paragraph 1;
b. searches for clinical trials by keyword.
3 The coordination service shall operate the portal and the additional federal database in accordance with Article 10 of the Organisation Ordinance HRA of 20 September 2013.
Article 41 ClinO-MD
The sponsor shall register the clinical trials in accordance with Articles 64 and 65 paras. 1 and 3, 66 and 68 ClinO.
Actor with an obligation to share data
Coordination service
Beneficiaries
All
Linking criteria for Switzerland
Linking criteria for Switzerland
Financial aspects
Not specified
Binding and/or enforceable
Mandatory
Conditions for accessing data
Not specified
Exceptions and limitations
Not specified
Dynamic data
Format
Portal
Plateform
https://kofam.ch/en/snctp-portal/searching-for-a-clinical-trial
Compilation and Disclaimer
This index was prepared on behalf of the IPI by the law firm id est avocats Sàrl (for the section on Swiss law) and the law firm Pierstone (for the section on European law).
This index does not constitute legal advice, and no guarantee is given regarding its completeness.
Neither id est avocats Sàrl, nor Pierstone, nor the IPI or the FDJP can be held liable for any decisions or actions taken on the basis of this index.