What is it? Why is it important?

Participant recruitment must be diligently documented which includes various logs, such as a:

  • Pre-Screening-Log: a list generated by the Site-INV listing potential study participants selected based on patient-file reviews. Potential participants are approached to assess interest in study participation
  • Screening-Log: a list of all participants screened for study eligibility (e.g. does the participant fulfil the defined inclusion and exclusion criteria of the study?)
  • Enrolment-Log: a list of participants who fulfil the study`s inclusion criteria while having none of the exclusion criteria. Based on study eligibility participants have agreed to participate in the study and have singed the study Informed Consent Form (ICF)
  • Identification-Log: a list that matches participant study ID with personal details such as participant name and date of birth. Participant identification is only possible through this log which must be kept separate at an access protected location (data confidentiality)


Screening- and Enrolment log can be a combined document.

What do I need to do?

As a Site-INV, document participant recruitment on an ongoing basis.


The date when the participant signs the ICF is the official date of study inclusion and is recorded in the:


The date on the ICF is the date when:

  • Participants become officially recorded in the study, and participant compliance becomes essential
  • Study relevant procedures can be implemented
  • Data is collected from participants
  • Safety assessment and reporting becomes mandatory
  • The study is 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

Where can I get help?

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


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
  • CRF – electronic Case Report Form
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ID – Identification
  • ISO – International Organization for Standardization
  • Site-INV – Site -Investigator
Conduct ↦ Management ↦ Participant Recruitment ↦ Documentation

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 ↦ Documentation

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