What is it? Why is it important?

Based on the 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
  • Database is ready for final closure
  • Essential documents are signed and filed in ISF and TMF and ready for archiving

More

Database ready for closure (locked) to be forwarded to the statistician for analysis

What do I need to do?

As a monitor ensure during COV that:

  • Drug accountability is complete an correct, (e.g. all used or unused IMP/MD are accounted for)
  • Unused IMP/MD 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)

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

More

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 EC and if applicable to RA 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

External Links

Link/Referenz zum Dokument der Ethikkommissionen über empfohlene Aufbewahrungs-/ Archivierungszeiten bei HFV-Projekten

References

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 - see in particular sections (access liable to cost)

  • 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
Abbreviations
  • COV – Close Out Visit
  • CTU – Clinical Trials Unit
  • eCRF- electronic CRF
  • EC – Ethic Committee
  • EC/RA - Ethics Committee / Regulatory Authorities
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ICF – Informed Consent Form
  • IMP/MD – Investigational Site File / Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • LPLV –Last Patient Last Visit
  • 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
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): Completion ↦ Management ↦ Study Closure ↦ Close-Out Visit

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