Your Easy Guide to Clinical Studies

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

• Pre-Screening-Log: a list generated by the Site-INV listing potential study participants selected based on patient-file reviews. Potential participants are approached to assess interest in study participation
• Screening-Log: a list of all participants screened for study eligibility (e.g. does the participant fulfil the defined inclusion and exclusion criteria of the study?)
• Enrolment-Log: a list of participants who fulfil the study`s inclusion criteria while having none of the exclusion criteria. Based on study eligibility participants have agreed to participate in the study and have singed the study Informed Consent Form (ICF)
• Identification-Log: a list that matches participant study ID with personal details such as participant name and date of birth. Participant identification is only possible through this log which must be kept separate at an access protected location (data confidentiality)

 

Screening- and Enrolment log can be a combined document.

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

 

The date when the participant signs the ICF is the official date of study inclusion and is recorded in the:

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

 

The date on the ICF is the date when:

• Participants become officially recorded in the study, and participant compliance becomes essential
• Study relevant procedures can be implemented
• Data is collected from participants
• Safety assessment and reporting becomes mandatory
• The study is 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

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