Your Easy Guide to Clinical Studies

The SP-INV is responsible for writing the study protocol. Once finalised, the SP-INV officially approves the protocol by dating and signing the signature page.  Other potential collaborators required to date and sign the protocol are the:

• Statistician responsible for the analysis of study results (e.g. statistical analysis plan)
• Site-INV(s) in a multicentre study responsible for a given study site
• Other relevant collaborators (e.g. a medical writer, laboratories analysing biological material, CRO or monitoring institution)

 

By signing the protocol, both the SP-INV and study collaborators confirm:

• The feasibility of delegated study tasks (e.g. the implementation of the study at a given site, analysis of biological material)
• Data confidentiality (i.e. storage of health related data and biological material)
• Ongoing compliance with the protocol from start to completion

 

Once signed the protocol:

• Must be approved by the Ethics Committee (EC) and if applicable Swissmedic (e.g. risk-category B and C)
• Is officially registered in a publically accessible registry

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As a SP-INV, write a protocol where:

• The research question is clear, supported by current scientific knowledge
• Ethics and regulatory requirements (e.g. Swissmedic, FOPH) are correctly sited
• Procedures are feasible, clear, and void of unsolicited interpretations (e.g. participant access and recruitment, administration of IMP/IMD, data collection, safety reporting, analysis of study results)
• Internal inconsistencies or mistakes are removed, and all relevant information is included

 

As a rule, a protocol is written in a manner that allows the study to be reproduced, later or by other researcher(s).

 

For persons signing the protocol, include contact details (e.g. name, study role, address). In multicentre studies, add a separate signature page for each participating Site-INV.

 

Aspects to consider:

• Any changes of an EC / Swissmedic approved protocol escalates an amendment
• In order to ensure data quality and participant safety, base the risk-management of your study on the study protocol

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Swiss Law

HRA – see in particular articles

• Art. 5 Scientifically relevant topic
• Art. 10 Scientific requirements

ClinO – see in particular articles

• Art. 1 d Study registration
• Art. 5 Rules of Good Clinical Practice
• Art. 18 Storage of health-related data and biological material
• Art. 19, 20, 49, and 61 Categorisation 
• Art. 24 – 29 Procedures for the Ethics Committee
• Art. 23, 27, 31 Procedures for the agency (Swissmedic)

ClinO-MD – see in particular article

• Art. 6 Categorisation of clinical investigations

HRO – see in particular article

• Art. 5 Storage of health-related data and biological material
• Art. 7 Categorisation