Your Easy Guide to Clinical Studies

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.

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