What is it? Why is it important?

The COV should be prepared carefully because it is the last visit to the site.

Activities relevant to the study must come to a close and the site must prepare for archiving.

A distinction should be made between site closure and study closure, as in multicentre studies, a particular site might close prior to the closure of the study (e.g. a site has completed its treatment of participants as specified and agreed in the SP-INV contract).


A COV can take place:

  • At the regular end of the study as foreseen in the study protocol
  • Due to premature closure or termination of the study


In most cases, the COV is performed by the monitor(s) and according to the MP. However, the SP-INV can appoint other personnel to perform this task. In any case, the SP-INV must ensure that those performing the COV are well qualified to take over study monitoring duties.

What do I need to do?

If you are the study monitor, ensure that during the COV:

  • All used and unused IMP/IMD are accounted for
  • Unused IMP/IMD and lab supplies are ready to be returned to the SP-INV, or the SP-INV designates unused IMP/IMD to be destroyed at the site
  • All database (CDMS) queries are resolved and no more changes are possible, thus database is ready for final lock
  • The end of the study is reported is to the EC and, if applicable to the RA (e.g. SwissmedicFOPH)
  • ISF and TMF filing are complete and up to date
  • The Site-INV is reminded of pending responsibilities


Pending responsibilities after the study COV include:

  • Data export and the statisical analysis of study results
  • The archiving of study relevant study documents needed to re-construc the study
  • To provide appropriate archiving premises during the entire defined archiving period (e.g. access, fire, humidity, and rodent protection)
  • To ensure that archived material remains accessible and legible during the entire archiving period
  • Submission of a CSR report to the EC
  • The registration and publication of study results
  • To be prepared for a possible audit or inspection by regulatory authorities

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)

  • 9.2.6 Clinical investigation close-out
  • Annex E: Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

  • Art. 38 Notification upon study completion, discontinuation, or interruption
  • CDMS – Clinical Data Management System
  • ClinO – Clinical Trials Ordinance
  • COV – Close-Out-Visit
  • CSR – Clinical Study Report
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • 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
  • MP – Monitoring Plan
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Completion ↦ Monitoring ↦ Close-Out Visit ↦ Conduct

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 ↦ Conduct

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