What is it? Why is it important?

Upon study end, study data and documents (e.g. essential documents) are file and archived in the TMF/ISF.  The aim is to retain the ability to reconstruct the study at some later date.


Archiving is the only available mean to verify that the:


Regardless whether documents are available as hard copies or in an electronic form, they must:

  • Remain legible during the entire archiving period
  • Be made available to the Ethics Committee (EC) and Swissmedic upon request
  • Be traceable in the event they become removed and returned from/to the archive
  • Be validated when subjected to a transfer medium (e.g. certified copies)


Archiving premises must be:

  • Access restricted to prevent theft, destruction, or forgery (e.g. access with personalised badge or key)
  • Protected against fire, humidity, and rodent infestation

What do I need to do?

As a SP-INV:

  • Familiarize yourself with legal archiving requirements (e.g. scope and duration)
  • Archive the study documentation on behalf of your role as the Sponsor (TMF)
  • Provide the Site-INV(s) with an archiving SOP, including instructions on:
    • Documents / data to be archived (e.g. ICF, participant-identification-log)
    • Acceptable archiving premises
    • Procedures for the retrieval and return of archived documents and data
    • Required duration of archiving
  • Notify the Site-INV(s) when study records are no longer needed. Include destruction procedures (e.g. documentation, data confidentiality)
  • Request a certificate of destruction


As a Site-INV:

  • Implement the archiving SOP of the SP-INV
  • As agreed, return selected data and documents to be archived with the SP-INV
  • If applicable, remind the SP-INV when the archiving duration is over
  • Follow required destruction procedures (e.g. documentation on how, when, and where documents were destroyed)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular  guideline

  • 5.5.6 Data retention

ISO 14155:2020 Medical devices (access liable to costs) – see in particular section and annex

  • 8.6 Document retention

ISO 20916:2049 In vitro diagnostic medical devices

Swiss Law

ClinO – see in particular articles

  • Art. 18 Storage of Health-Related Personal Data and Biological Material
  • Art. 45 Data retention requirements

ClinO-MD – see in particular article

  • Art. 40 Document retention requirements
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practices
  • ISO – International Organization for Standardization
  • ISF – Investigator Site File
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ Archiving ↦ Requirements

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 ↦ Ethics and Laws ↦ Archiving ↦ Requirements

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