What is it? Why is it important?

Before participants can be recruited in a study, they have to:

  • Sign the study`s Informed Consent Form (ICF), which confirms their agreement to participate in the study
  • Be screened regarding the study`s inclusion and exclusion criteria


Screening is done after the participant has been adequately informed about the study and has signed the ICF.


Screening incudes to:

  • Assess the participant`s patient file to ensure inclusion / exclusion criteria are met (e.g. diagnosis / healthy volunteers, disease stage, co-morbidities, medication intake, treatment naïve, blood analysis, age, gender)
  • Interview the participant (e.g. current smoking- and drinking habits, intake of over the counter medications, activity / sleeping patterns, transport means and time at disposal)
  • Perform specific screening tests (e.g. pregnancy, infectious diseases, blood type)


The SP-INV or Site-INV is responsible to ensure that participants are:

  • Unmistakably informed about the study and understand what it entails (e.g. time investment, provision of biological material and health related data, administration of IMP/IMD, the expected risk-benefit ratio of the study)
  • Given ample opportunity to ask questions in order to make a sound decision
  • Given adequate time to decide
  • Informed regarding their right to withhold or revoke their consent at any time, without sating any reasons
  • Informed that revoking consent has no bearings on ongoing or future medical treatment or care


Neither SP-INV / Site-INV, nor the study staff, should coerce or unduly influence participants to participate or continue to participate in a study.

What do I need to do?

As a SP-INV define an IC process to be complied with during study conduct, such as to:

  • Document ICF tasks and responsibilities in a site delegation-log (who informs and recruits participants)
  • Ensure each participant is:
    • Provided with his/her personal ICF
    • Enters his/her name, gender, and date of birth
    • Personally enters place, dates and signs the ICF
  • Ensure the Site-INV(s):
    • Enters name (legibly) and personally dates and signs the ICF (after the participant)
    • Documents the time when ICF was obtained. This is especially important if study relevant procedures are planned the same day
    • Provides the participant with a signed copy of the ICF
    • Makes a note in the patient file and the study database (e.g. CRF) confirming participant recruitment
  • Files the ICF in the ISF


As a SP-INV and Site-INV do not:

  • Use an old outdated or unapproved ICF version (e.g. unapproved by Ethics Committee (EC))
  • Leave date and place empty or pre-enter date & place on behalf of the participant
  • Forget to make participant sign the ICF document
  • Personally forget to sign the ICF document
  • Have the ICF document signed by a non-authorised staff member

Where can I get help?

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

External Links

Swissethics – in particular see

  • Time for consideration


ICH GCP E6(R2) – see in particular guidelines

  • 1.28 Informed consent definition
  • 4.8 Informed consent of trial participants


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

  • 5.8 Informed consent
  • 10.5 Informed consent procedure

Swiss Law

HRA – see in particular article and chapter

  • Art. 7 Consent
  • Chapter 2, section 2. Information and consent

ClinO – see in particular articles

  • Art. 7 Information given to participants
  • Art. 9 Consequences of revocation of consent
  • Art. 15 Post hoc consent in emergency situations

ClinO-MD – see in particular article

  • Art. 3b Applicable provisions

HRO – see in particular articles and chapter

  • Art. 8 Information given to participants
  • Art. 10 Consequences of revocation of consent
  • Art. 11 Research projects in emergency situations
  • Chapter 3, section 2. Informed consent and information in further use of biological material and health-related data
  • ClinO – Clinical Trials Organisation
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • HRA – Human Researcg Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD - Investigational Medicinal Product / Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Conduct ↦ Management ↦ Participant Recruitment ↦ Screening and Consent

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Management ↦ Participant Recruitment ↦ Screening and Consent

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