What is it? Why is it important?

The protocol is the core document that describes the background, rationale, objective(s), design, statistical method, including safety aspects of a study.

By approving and signing the study protocol, the SP-INV, including any participating Site-INV(s) and other potential signees (e.g. statistician) confirm their commitment to conduct the study according to:

  • Specifications given in the protocol
  • The Declaration of Helsinki
  • If applicable ICH-GCP guidelines
  • ISO 14155 for studies with medical device
  • The Swiss law (e.g. data protection laws, HRA, ClinO, ClinO-MD, HRO)

A protocol must have clearly marked identifiers (e.g. protocol version number, release date). In the event of protocol changes or amendments, requires that identifiers are adapted accordingly. This is important as ECs or RAs who approve study protocols, does this on the basis of a particular protocol version.

More

A given protocol version does not only define how to conduct a study, but is also the basis for any audits or inspections by a SP-INV or RA (e.g. Swissmedic), respectively.

What do I need to do?

As a SP-INV:

  • Select and download the official protocol template applicable to your study from the swissethics webpage
  • Fill in all required study information (e.g. rational, study design, safety issues)
  • Include reviews by applicable experts who contribute to its content (e.g. statistician, quality-, project-, data manager, study nurse)
  • Consider to have the protocol reviewed by an impartial expert who can provide important professional support
  • Place the synopsis at the beginning of the protocol

Invest sufficient time in protocol development, as a well prepared and thought through protocol will:

  • Avoid unexpected difficulties, requiring protocol amendments due to protocol inconsistencies during study conduct
  • Save not only resources and costs, but also the required time needed to complete the study (e.g. amendments are costly and do significantly delay the study)

For more information refer to Protocol in this Study Guide.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Broad selection of protocol templates

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.44 Protocol definition
  • 1.45 Protocol Amendment
  • 2.5, 2.6 Principles of ICH GCP
  • 6 Clinical Trial Protocol and Protocol Amendment(s)

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • 6.4 Clinical Investigational Plan (CIP)
  • Annex A CIP

Declaration of Helsinki – see in particular principles

  • 21 – 22 Protocol requirements

Swiss Law

ClinO – see in particular articles

  • Art. 19, 20, 49, and 61 Categorisation
  • Art. 29 Changes

HRO – see in particular articles

  • Art. 7 Categorisation
  • Art. 18 Changes
Abbreviations
  • ClinO - Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRA – Human Research Act
  • HRO - Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Documents ↦ Required Documents ↦ Study Protocol
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Documents ↦ Required Documents ↦ Study Protocol

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