What is it? Why is it important?

A study is closed once the last study participant has had his/her last study visit.


Upon study closure, various activities are implemented, such as:

  • To conduct a monitoring close-out visit
  • To conclude IMP management (e.g. accountability, return to SP-INV, destruction)
  • To ensure that all participant (S)AEs are correctly documented and closed (e.g. resolved or stabilised)
  • To lock the study CDMS (eCRF) and to export the data for statistical analysis. The study database can only be locked once the required dataset is complete (e.g. no missing data) and  all queries have been resolved
  • To inform the EC and if applicable RA (e.g. Swissmedic) about study closure (e.g. and if applicable also study participants)
  • To write and submit a clinical (final) study report to EC and if applicable RA
  • To update all required registries (e.g. international public registry, federal database)
  • To publish study results (e.g. scientific publications)
  • To prepare study documents for archiving (electronic and hard copies)

What do I need to do?

As a SP-INV and Site-INV complete and finalize upon study closure the document management of your study:

  • Date and sign the study CRF (electronic and paper)
  • Complete the finalise the filing of all essential and relevant quality documents in the study TMF/ISF


Complete the filing of all relevant study logs and ensure they are all dated and signed (e.g. identification-, delegation-, IMP accountability-, monitoring visit log)

Prepare documents for archiving and establish a document filing system that guarantees document identification and traceability. This will allow for easy document retrieval at some later date.

At study closure, left over study IMP/IMD is either destroyed or returned to the SP-INV of the study.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

  • CDMS - Clinical Data Management System
  • CRF – Case Report Form (p – paper; e – electronic)
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IMP – Investigational Medicinal Product
  • ISF – Investigator Site File
  • (S)AE – (Serious) Adverse Event
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Completion ↦ Documents ↦ Required Documents ↦ Study Closure

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 ↦ Documents ↦ Required Documents ↦ Study Closure

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