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.

During PS:

  • 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.

More

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

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

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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