What is it? Why is it important?

The COV report documents activities performed during the COV, such as:

  • Recording of staff attendance
  • Final check of TMF/ISF and essential documents in order to prepare for document archiving
  • Final IMP/IMD and study material accountability check
  • Left over IMP/IMD ready to be returned and destroyed by the SP-INV, or the SP-INV delegates destruction tasks to the Site-INV
  • Final query resolution, with database (CDMS) ready to be locked, so as no more changes are possible
  • Study data ready for export and data analysis
  • The selection of appropriate archiving premises able to safeguard archived documents over the entire archiving period


After the COV is completed, all previously unresolved issues should be resolved. The SP-INV and monitor must ensure that there are no unresolved issues after the final COV.

What do I need to do?

As the study monitor who performs the COV, write its report and include a list of resolved issues, such as:

  • Queries resolved
  • TMF/ISF filing completed
  • Database locked
  • IMP/IMD returned to SP-INV or destroyed at the site
  • Archiving premises selected
  • EC and of applicable RA (e.g . Swissmedic) informed about the end (or termination) of the study


Forward the report to the SP-INV for review and include your comments. Incorporate any relevant SP-INV changes into the report. Together with the SP-INV date and sign the COV report, and file it in the TMF. The site does not receive a copy of the COV report. However, the Site-INV receives a follow-up letter summarising the visit and to be filed in the ISF.

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)

  • Monitoring reports
  • Annex E: Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

  • Art. 38 Notification upon study completion, discontinuation, or interruption


  • ClinO – Clinical Trials Ordinance
  • COV – Close-Out-Visit
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee/Regulatory Authorities
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • ISO – International Organisation for Standardisation
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Completion ↦ Monitoring ↦ Close-Out Visit ↦ Report

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): Completion ↦ Monitoring ↦ Close-Out Visit ↦ Report

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