What is it? Why is it important?

The Participant Information Sheet (PIS) is any information given to participants describing a study, including the use / further use of collected biological material and health related data.

Selection of PIS is based on the following criteria:

  • Type of study according to the law (ClinO, HRO)
  • The Swiss language region where participants are recruited (German, French, Italian)
  • Type of recruited participants (e.g. adults, children, adolescents, pregnant women, individuals without capacity to give consent)

More

It might be necessary to provide the PIS in a language other than an official Swiss language:

  • Translations must be submitted to the EC, who will acknowledge the translated document.
  • The SP-INV is responsible for the correct translation
  • In the event of languages for which a written translation is not feasible, a qualified translator can be used to inform participants

What do I need to do?

Categorise your study based on the Swiss law. If in doubt, clarify the category of your study upfront with the EC.

  • Select the applicable PIS template provided by swissethics based on:
    • Type of study: interventional clinical study (ClinO) versus nonclinical research project (HRO) with the exclusive collection of biological material or health related data
    • Type of population (e.g. adults, children, pregnant women, other vulnerable groups)
  • Include all relevant information enabling participants or legal representatives to decide on study participation
  • Ensure text is written in a comprehensible language easy understood by recruited target participants
  • Submit the PIS to be approved by EC before being used

For more information refer to Ethics and Laws 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 PIS templates
  • Further use of biological material and personal data
  • Study information for relatives/parents/legal representative
  • Conception and application of an electronic informed consent
  • Information of participants in foreign languages
  • Application of the General Data Protection Regulation (GDPR)

References

ICH GCP E6(R2) – see in particular guideline

  • 4.8. Informed consent of trial participants

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

  • 5.8 Informed consent

Declaration of Helsinki – see in particular principles

  • 25 – 32 Informed Consent

Swiss Law

HRA – see in particular

  • Chapter 2, section 2. Information and consent

HRO – see in particular articles

  • Art. 8 Information given to participants
  • Art. 9 Exemption to written form
  • Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data

ClinO – see in particular articles

  • Art. 7 Information given to participants
  • Art. 8.Exemption to written form
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • HRO – Human Research Ordinance
  • PIS – Participant Information Sheet
  • Site-INV – Site-Investigator
Development ↦ Management ↦ Study Documents ↦ Participant Information Sheet
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 ↦ Management ↦ Study Documents ↦ Participant Information Sheet

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