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, left over study IMP/IMD and applicable study material must also be destroyed, or as agreed returned to the SP-INV of the study.

What do I need to do?

As SP-INV:

  • Define preventative 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 preventative 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

References

ICH GCP E6(R2) – see in particular guidelines

  • 5.5.12 Notification of destruction
  • 8.4.2 Documentation of IMP Destruction
Abbreviations
  • 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
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 ↦ Document Destruction

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