Conduct↦Management↦Participant Recruitment↦Documentation of Recruitment
What is it? Why is it important?
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.
What do I need to do?
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.
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
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