Conduct↦Management↦Participant Recruitment↦Screening and Consent
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
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.
- Is provided with his/her personal ICF
- Enters his/her name, gender, and date of birth
- Personally enters place, dates and signs the ICF
- 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
- 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.
- 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
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 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