Your Easy Guide to Clinical Studies

Participant recruitment must be diligently documented starting with:

• Pre-Screening: a list generated by Site-INVs and based on patient chart reviews, listing potential study participants to be approached for the study
• Screening-Log: a list of all participants screened for study eligibility
• Enrolment-Log: a list of recruited participants fulfilling inclusion criteria with none of the exclusion criteria
• Identification-Log: a list that matches participant study ID with personal details (name, date of birth)

Screening and Enrolment log can be in a combined document.

Document participant recruitment on an ongoing basis.

The date of participant consent is recorded in:

• SD (e.g. participant medical record, study worksheets, etc.)
• The study specific CRF (pCRF) and electronically in the database (eCRF)

The consent date is the official study starting point for participants as:

• They become officially recorded as study participants
• Study relevant procedures can be implemented
• Participant compliance becomes essential
• Collected data is recorded
• Safety documentation and reporting becomes mandatory
• The study becomes liable regarding insurance claims

Maintain ongoing surveillance regarding recruitment progress. Potential countermeasures might become necessary in the event that:

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

 

For more information refer to Documents in this Study Guide.

References

ICH GCP E6(R2) – see in particular guidelines

• 4.8 Informed consent of trial subjects
• 8.3 During the Clinical Conduct of the Trial

 

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

• 5.8 Informed consent
• 10.5 Informed consent procedure