What is it? Why is it important?

The monitor forwards a Follow-Up (FU) letter / e-mail to the Site-INV summarizing:

  • The scope of the performed COV, including a list of the performed action items (e.g. query resolution, database ready for closure, completion and filing of study documents)
  • The handling of IMP/IMD and other study material
  • Site archiving procedures
  • The possibility that a study site may be inspected even after the study closure


What do I need to do?

If you are the study monitor, write a FU letter / e-mail to the Site-INV and include:

  • Query resolutions and completion of study data entry, with database ready for closure
  • TMF/ISF tracking and the completion of essential documents needed for archiving
  • Final IMP/IMD accountability, with unused products returned to SP-INV or destroyed at the site
  • Lab material inventory check and leftover supply returned to SP-INV or destroyed at the site
  • Definition of archiving procedures and duration, including the selection of appropriate archiving premises (e.g. access, fire, humidity, and rodent protection)
  • Possibility of an inspection


The site-INV files the FU letter / e-mail in the ISF. The monitor retains a copy of the letter / e-mail


In the event the Site-INV is responsible for the destruction of IMP/MD or other relevant study material, an initial destruction approval letter must be forwarded from the SP-INV to the Site-INV

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)

  • 9.2.4 Monitoring
  • Annex E: Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

  • Art. 38 Notification upon study completion, discontinuation, or interruption
  • ClinO – Clinical Trials Ordinance
  • COV – Close-Out-Visit
  • CTU – Clinical Trials Unit
  • FU – Follow-Up Letter
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • 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
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Completion ↦ Monitoring ↦ Close-Out Visit ↦ Follow-Up Letter

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 ↦ Monitoring ↦ Close-Out Visit ↦ Follow-Up Letter

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