What is it? Why is it important?

The Close-Out Visit (COV) is the last monitoring visit and thus completes the monitoring aspect of the study.

The site is ready for closure once the following criteria are met:

  • The last study participant has completed his or her last study visit
  • All required study data has been collected and all eCRF entries in the study database (CDMS) are complete
  • Queries have been resolved and database irregularities have been corrected. Thus the study database is ready for closure
  • Essential documents have been dated and signed and filed in either ISF and/or TMF and consequently ready for archiving


Once the study database has been closed (locked), the data can be exported and forwarded to the statistician for analysis.

What do I need to do?

Confer with the study monitor and the study site in order to determine if closure criteria are fulfilled, and the site is ready for the COV.

Consult with the site to schedule the COV and inform the site of:

  • The estimated time required
  • Documents that need to be reviewed prior to archiving
  • Required access to electronic records
  • Which staff must be present in order to complete study closure (e.g. Site-INV, responsible study nurse)


Make sure that the Site-INV has sufficient time for a final discussion. During this discussion, a retrospective analysis of study performance can be summarised (e.g. lessons learned).


Lessons learned should be recorded because they provide important guidance for subsequently potential future studies.


Ideally, the COV is conducted after database lock. Also, potentially one could combine a Routine Monitoring Visits (RMV) with a COV, although this is not recommended

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

  • 5.18 Monitoring activities
  • 8. Essential documents for the conduct of a clinical trial


ISO 14155 Medical Device – see in particular section (access liable to costs)

  • 9.2.4 Monitoring
  • Annex E: Essential clinical investigation documents
  • CDMS – Clinical Data Management System
  • COV – Close-Out-Visit
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • Site-INV – Site Investigator
  • ISO – Investigational Organisation for Standardisation
  • TMF – Trial Master File
Completion ↦ Monitoring ↦ Close-Out Visit ↦ Preparation

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

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

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Monitoring ↦ Close-Out Visit ↦ Preparation

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