Your Easy Guide to Clinical Studies

Participant recruitment must be diligently documented which includes various logs, such as a:

• Pre-Screening-Log: lists potential study participants selected based on patient-file reviews, including the study`s main inclusion / exclusion criteria. Potential participants are approached to assess interest in study participation

 

• Screening-Log: lists all participants who have signed the Informed Consent Form (ICF), and that are further screened for study eligibility (e.g. does the participant fulfil the defined inclusion and exclusion criteria?). During screening, applicable screening test can be performed (e.g. blood tests)

 

• Enrolment-Log: lists participants who fulfil the study`s inclusion criteria while having none of the exclusion criteria assessed during screening. Participants have agreed to participate in the study, and did sign the ICF (i.e. prior to screening)

 

• Identification-Log: a list that matches the study ID of the participant with personal details such as participant name and date of birth

 

Screening- and Enrolment log can be a combined document.

As a Site-INV, document participant recruitment on an ongoing basis during study conduct.

 

The date when the participant signs the ICF is the official date of study inclusion . Document the date in the:

• Participant patient-file
• Study database (eCRF)
• Other relevant  documents, as applicable (e.g. source data)

 

The date on the ICF is the date when:

• Study relevant procedures can be implemented
• Data is collected from participants
• Participant compliance becomes essential
• Safety assessment and reporting becomes mandatory
• The study is liable regarding insurance claims

 

Participant identification is made possible through the study Enrolment-log. In order to guarantee participant confidentiality the log should be kept separate at an access protected location

Maintain ongoing surveillance regarding recruitment progress. Potential countermeasures might become necessary if:

• Recruitment is slower than expected
• Number of eligible patients is low
• Participant drop-out is high

 

 

References

ICH GCP E6(R3) – see in particular guidelines

• II. Principles of ICH GCP Nr. 2 Informed consent
• Glossary: Definition Informed Consent
• 2.8. Informed consent of trial participants
• C.3 Essentiality of Trial Records

CH GCP E6(R3) – Annex 2 – see in particular guideline

• 2.2 Informed Consent Considerations

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

• 5.8 Informed consent
• 10.5 Informed consent procedure