What is it? Why is it important?

After the completion of the required archiving period, all study documents, be it in paper or electronic form, can be destroyed.


The destruction of study documents:

  • Can only be done at participating study site after a written approval by the SP-INV
  • Must be done in a manner that ensures that data protection laws are complied with at all times
  • Requires that destruction means, date and place are recorded
  • Requires that the destruction certificate, confirming destruction, is kept and archived for later reference


Apart from the destruction of study documents and study data, potentially left over study material (e.g. lab or analytical equipment) must also be destroyed, or as agreed returned to the SP-INV of the study. A return or destruction of IMP/IMD occurs at study termination and not at the end of the archiving period.

What do I need to do?


  • Define preventive measures to avoid accidental or premature destruction of study documents
  • Define destruction procedures and guidelines in an SOP
  • In a multi-centre study, notify the Site-INV in writing when study related records are no longer needed
  • Ensure the destruction of study documents is properly documented. This includes any destruction performed by participating study sites
  • If destruction is delegated to a study external partner, ensure destruction procedures are according to required SOP guidelines, with data protection issues respected at all times


As a Site-INV:

  • Define preventive measures to avoid accidental or premature destruction of study documents
  • Follow destruction procedures as defined in the SOP provided by the SP-INV, or according to local destruction procedures approved by the SP-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

  • 5.5.12 Notification of destruction
  • 8.4.2 Documentation of IMP Destruction
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • IMP – Investigational Medicinal Product
  • IMD – Investigational Medical Device
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
Completion ↦ Documents ↦ Required Documents ↦ Document Destruction

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 ↦ Document Destruction

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