What is it? Why is it important?

Pre-Screening (PS) takes place before participants give consent to study participation (e.g. sign the Informed Consent Form (ICF)).  The aim of PS is to be able to identify potential study participants eligible for the study.


At a participating study site(s), study eligibility is evaluated by pre-screening potential participants and their ability to fulfil the inclusion/exclusion criteria of the study y (e.g. medical history, diagnosis, co-morbidities, disease stage, age, gender, healthy volunteers, pregnancy, treatment naïve)


No study specific procedures are performed during PS. Study specific procedures are only implemented once participants have signed the ICF.


The access and availability of potential study participants will highly affect the ability to recruit participants for the planned study.

What do I need to do?

As a SP-INV and Site-INV, based on study eligibility:

  • Inform physicians about the study and ask them to review patient files from potential participants under their care. Instruct them that potential study candidates should only be approached during scheduled consultations, or by phone
  • Maintain a PS-log


As a study SP-INV/Site-INV you can only contact participants who confirmed to their treating physician that they:

  • Had an interest in study participation
  • Did agree to be contacted by study representatives (e.g. SP-INV/Site-INV, study nurse)



Once a participant is deemed eligible, and is interested in study participation:

  • Provide participants with applicable documents (e.g. PIS, ICF)
  • Schedule a “screening and consent” visit


In the PD-log list all participants that were pre-screened for the study. Include both eligible and non-eligible participants, irrespective whether they agreed to study participation or not. File the PS-log in the ISF

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • PIS – Participant Information Sheet
  • PS – Pre-Screening
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Management ↦ Participant Recruitment ↦ Pre-Screening

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Management ↦ Participant Recruitment ↦ Pre-Screening

Please note: the Easy-GCS tool is currently under construction.