What is it? Why is it important?

In order to decide whether a participant is eligible for study participation, they must be screened based on study inclusion and exclusion criteria. In addition, only participants that have signed the ICF have officially consented to participate in the study and can be screened for study inclusion.

Screening assessment is based on:

  • Existing medical records (e.g. disease specifications, co-morbidities, medication intake, blood analysis)
  • Patients interviews (e.g. current smoking- and drinking habits, intake of over the counter medications, transport means and time at disposal)
  • Study specific screening test

More

Participant screening assessments can only be performed after the participant has been informed about the study and agreed to participate. He or she has signed the ICF.

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

  • Unmistakably informed and understand their contribution to the study (e.g. time investment, provision of biological material and health related data, administration of IMP/MD, reporting of adverse events)
  • 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 stating reasons why participation is no longer desired
  • Informed that revoking consent has no bearings on ongoing or future medical treatments or care given to participant.

Neither investigator, 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?

Participant informed consent is documented in writing.

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

SP-INV/Site-INV:

  • Enters name (legibly) and personally dates and signs the ICF after the participant
  • Provides the participant with a signed copy of the ICF
  • Makes a note in the medical record and study database confirming study inclusion
  • Files signed and dated ICF in ISF

More

  • The study delegation log must clearly list designated study staff responsible for informing participants about the study, including dating and signing the ICF. In most cases, this would be the SP-INV or a Site-INV.
  • Document time when ICF was obtained. This is especially important if study relevant procedures are planned the same day.
  • Only after the participant has signed the ICF can study procedures start (e.g. participant questionnaire, analytical screening tests)

Ensure that all hand-written text is clearly legible, personal signatures excluded.

Do not:

  • Use an old outdated ICF version
  • Leave date and place empty
  • Pre-enter date & place on behalf of the participant
  • Forget to make participant sign the document
  • Personally forget to sign the document
  • Have the document signed by a non-authorised staff member
  • In a multicentre study forward signed and dated ICF documents of a participating study site to the SP-INV of the study
  • Throw away any signed ICF (e.g. in the event of participant drop out or screening failure)

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

References

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 - see in particular sections (access liable to cost)

  • 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

HRO – see in particular articles

  • 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
Abbreviations
  • CTU – Clinical Trials Unit
  • 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
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): Conduct ↦ Management ↦ Participant Recruitment ↦ Screening and Consent

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