What is it? Why is it important?
Pre-Screening (PS) takes place before participants give consent to study participation. The aim is to determine initial participant eligibility.
- No study specific procedures are performed
- Eligibility among patient population at a planned study site is evaluated
PS practices are common in most study sites in order to:
- Quickly identify eligible study participants
- Evaluate study feasibility based on patient availability at the study site
Study eligibility is based on the defined inclusion- and exclusion criteria of the study (e.g. diagnosis, co-morbidities, disease stage, age, gender, healthy volunteers, pregnancy, treatment naïve)
What do I need to do?
Based on study eligibility:
- Review medical records of your patients
- Inform other site physicians about the study, and ask them to review patients’ medical records under their care
- Maintain a Pre-Screening log
As a treating physician only approach potential patients:
- During scheduled consultations
- By phone
The Site-INV can only contact potential patients who confirm an interest in the study to their treating physician and have agreed to be contacted regarding study participation.
Once a potential participant is eligible and interested in study participation, you may:
- Hand out or forward applicable documents to the participant (e.g. PIS, ICF)
- Schedule a “screening and consent” visit
The pre-screening log should contain all patients that were:
- Scheduled and went through a “screening and consent” visit
- Found to be either eligible or non-eligible
- Found to be interested or non-interested in study participation
File the pre-screening log in the ISF
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch