What is it? Why is it important?

Upon study termination all essential and other relevant quality documents are archived. This is essential in order to reconstruct the study at some later date.


To retain access to archived documents is the only reliable mean to verify that:


In Switzerland the required archiving period depends on study type. Studies with investigational:

  • Medicinal Products (IMP) have a minimum archiving period of 10 years (e.g. ClinO)
  • Studies with transplantation into humans (TPA) have a minimum archiving period of 15 years (e.g. ClinO)
  • Medical Devices (IMD) have a minimum archiving period of 15 years (e.g. ClinO-MD)

What do I need to do?


  • Make a list of documents to be archived. Establish an archiving index for ease of retrieval at some later date
  • Define documents that must remain archived at participating study sites (e.g. participant identification logs)
  • Write an archiving SOP
  • Ensure study sites comply with the SOP and the required archiving period
  • Notify the study site when records are no longer needed. Include required destruction procedures (e.g. destruction certificate)


As a SP-INV and Site-INV ensure that during the entire archiving period:

  • Documents (electronic and hard/paper copies) remain legible.
  • Document transfers to another medium are validated (e.g. certified copies)
  • Only authorised personnel retain access to the archive 
  • The removal and retrieval of archived documents is recorded
  • Premises are protected against fire, humidity and rodent infestation


In the event of an audit or inspection ensure archived documents are made readily available upon request.


For more information refer to Documents in this Study Guide.

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 Trial management, data handling, and record keeping
  • 5.5.6 Data retention

Swiss Law

HRO – see in particular article

  • Art. 5 Storage of data and biological material

ClinO – see in particular article

  • Art.45 Data retention

ClinO-MD - see in particular

  • Art. 40 Data retention requirements

TPA - see in particular article

  • Art. 2a Scope
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor-Investigator
  • TPA – Transplantation Act
Completion ↦ Quality and Risk ↦ Archiving ↦ Study Records

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking

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

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Set-Up Biobanking

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

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 ↦ Quality and Risk ↦ Archiving ↦ Study Records

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