What is it? Why is it important?

The protocol is the core document that:

  • Describes the study background, rationale, objective(s), outcome(s), design, assessment(s), statistical method(s), including applicable safety aspects
  • Lays down the rules for study conduct, that must be complies with by study staff

The protocol synopsis is a short summary of the protocol and provides a kind of roadmap or panoramic view of the planned study.

The protocol is often an extensive document. As a result, the synopsis is often presented when applying for grants or seeking other types of support.

Swissethics provides a selection of mandatory protocol templates. Which template to use depends on study:

  • Type with ClinO, ClinO-MD versus HRO studies (e.g. intervention versus other- or non-clinical studies)
  • Risk category (A, B or C)

What do I need to do?

Based on your planned study:

  • Start by selecting the applicable protocol template provided by swissethics. The template ensures that you will include all protocol required information. If unsure clarify with EC beforehand
  • Consider what additional support or expertise must be recruited for the protocol write-up (e.g. a study statistician, quality-, project-, data manager, an experienced study nurse)

In the protocol evaluate what kind of impact study findings wouls have on public health. In other words, how will study findings contribute to disease prevention and/or contribute to any health improvement of your target population.

For more information refer to Protocol in this Study Guide.

More

For the development of the study protocol:

  • Analyse the particular medical/public health problem under investigation, and include a review of current existing knowledge
  • Define the hypothesis and objectives (research question(s)) of your study.
  • Calculate the study sample size needed to answer the research question(s)
  • Based on the research question(s), choose the appropriate study design
  • Decide on achievable and measurable study endpoints (outcome measures), including applicable statistical methods needed for data analysing
  • Describe current knowledge regarding IMP/MD safety profiles. Consider the implementation of preventive measures
  • Consider the procurement and handling of the IMP/MD
  • Determine study visit assessments / study schedule

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 Change

HRO – see in particular articles

  • Art. 7 Categorisation
  • Art. 18 Change
Abbreviations
  • ClinO - Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO - Human Research Ordinance
  • IMP– Investigational Medicinal Product
  • MD – Medical Device
Concept ↦ Documents ↦ Required Documents ↦ Protocol and Synopsis
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): Concept ↦ Documents ↦ Required Documents ↦ Protocol and Synopsis

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