Your Easy Guide to Clinical Studies

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.

As SP-INV:

• 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

References

ICH GCP E6(R2) – see in particular guidelines

• 5.5.12 Notification of destruction
• 8.4.2 Documentation of IMP Destruction