What is it? Why is it important?

Participant recruitment must be diligently documented starting with:

  • Pre-Screening: a list generated by Site-INVs and based on patient chart reviews, listing potential study participants to be approached for the study
  • Screening Log: a list of all participants screened for study eligibility
  • Enrolment Log: a list of recruited participants fulfilling inclusion criteria with none of the exclusion criteria
  • Identification Log: a list that matches participant study ID with personal details (name, date of birth)

Screening and Enrolment log can be in a combined document.

What do I need to do?

Document participant recruitment on an ongoing basis.

The date of participant consent is recorded in:

  • SD (e.g. participant medical record, study worksheets, etc.)
  • The study specific CRF (pCRF) and electronically in the database (eCRF)

The consent date is the official study starting point for participants as:

  • They become officially recorded as study participants
  • Study relevant procedures can be implemented
  • Participant compliance becomes essential
  • Collected data is recorded
  • Safety documentation and reporting becomes mandatory
  • The study becomes liable regarding insurance claims

For more information refer to Documents in this Study Guide.

More

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

References

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 - see in particular sections (access liable to cost)

  • 5.8 Informed consent
  • 10.5 Informed consent procedure
Abbreviations
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ID – Identification
  • ISO – International Organization for Standardization
  • pCRF – paper Case Report Form
  • SD – Source Data
  • Site-INV – Site -Investigator
Conduct ↦ Management ↦ Participant Recruitment ↦ Documentation of Recruitment
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 ↦ Documentation of Recruitment

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