What is it? Why is it important?

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:

 

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:

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Study registration:

  • Is mandatory for interventional studies and highly recommended for observational studies. Several scientific journals only publish interventional studies registered in a clinical trials registry
  • Fulfils research transparency and promotes result propagation
  • Is updated in accordance with registry requirements, but at least once a year

What do I need to do?

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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  • Electronic signatures are only acceptable if based on approved electronic signature procedures
  • Once approved by EC and if applicable Swissmedic, the protocol becomes binding and must be complied with during study conduct
  • Changes to an approved protocol escalates an amendment that requires prior EC / Swissmedic approval. Exception are safety and protective measures needed to protect study participants

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CRO - Contract Research Organisation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FOPH – Federal Office of Public Health
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Protocol ↦ Writing the Protocol ↦ Responsibilities
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Protocol ↦ Writing the Protocol ↦ Responsibilities

Please note: the Easy-GCS tool is currently under construction.