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
  • To inform the EC and if applicable RA 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.

More

Experienced staff at your local CTU can provide you with support on this topic.

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
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 ↦ Documents ↦ Required Documents ↦ Study Closure

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