What is it? Why is it important?

Based on the Monitoring Plan (MP) of the study, the Close-Out Visit (COV) represents the last monitoring visit of the study. The COV thereby completes study monitoring.


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

  • The last study participant has completed his/her last study visit (Last Patient Last Visit, LPLV)
  • Required study data are collected and (e)CRF entries are complete
  • Queries are resolved and eCRF / database irregularities are corrected
  • The study database is ready for final closure
  • Essential documents are signed and filed in ISF and TMF and ready for archiving


Once the database is locked it can be forwarded to the statistician for analysis.

What do I need to do?

As a monitor ensure during COV that:

  • Drug accountability is complete and correct, (e.g. all used or unused IMP/IMD are accounted for)
  • Unused IMP/IMD and lab supplies are ready for return to SP-INV or to be destroyed at the site
  • All CRF queries are solved with no more changes possible
  • Study-end is communicated to EC and if applicable to RA
  • ISF and TMF are complete and up to date
  • All note-to-files are correctly filed
  • Site-INV is reminded of pending responsibilities
  • Archiving period is known to Site-INV (information printed on files / boxes)


The study SP-INV and participating Site-INV(s) are responsible for the correct closure and archiving of the study. This will allow for the reconstruction of the study at some later date.


For more information refer to Monitoring, Data Handling and Documents in this Study Guide.


The COV should be well prepared as it is the last visit to the site. Study relevant aspects must come to a close and the site must prepare for archiving.


Pending responsibilities after study COV include to:

  • Submit a Clinical Study Report (CSR) to the Ethics Committee (EC) and if applicable to RA (e.g. Swissmedic) within one year
  • Publish study results
  • Archive study documents
  • Provide appropriate archiving premises during the entire defined archiving period, (e.g. access-, fire-, humidity-, and rodent protection)
  • Ensure that archiving material remains accessible and legible during the entire archiving period
  • Remain prepared for the possibility of an 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

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


ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections

  • 8.3 Routine close out
  • Annex E – Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

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

HRO – see in particular article

  • Art. 22, 36, 40, 43 Specifications regarding notification upon completion or discontinuation of a research project
  • COV – Close Out Visit
  • CTU – Clinical Trials Unit
  • CSR – Clinical Study Report
  • eCRF- electronic Case Report Form
  • EC – Ethics Committee
  • EC/RA - Ethics Committee / Regulatory Authorities
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ICF – Informed Consent Form
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • LPLV –Last Patient Last Visit
  • MP – Monitoring Plan
  • PIS – Patient Information Sheet
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
  • RA – Regulatory Authority
Completion ↦ Management ↦ Study Closure ↦ Close-Out Visit

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 Statistic Methodology
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 Statistic Methodology
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 Statistic Methodology
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Completion ↦ Management ↦ Study Closure ↦ Close-Out Visit

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