What is it? Why is it important?

When archiving study documents (e.g. electronic and paper), specific guidelines apply. The aim is to comply with regulatory requirements and to guarantee optimal archiving condition during the entire archiving period.


Guidelines include to:

  • Ensure essential document are filed according to specified filing procedures facilitating retrieval at some later date (e.g. master index)
  • Establish procedures that guarantee that study information remains legible during the entire archiving period. This includes both electronic, paper, and copied information
  • Ensure the multiple backup of electronic documents
  • Establish archiving premises with:
    • Access control
    • Fire protection and fire-safe lockers
    • Water damage protection
    • Temperature and humidity monitoring to ensure that levels remain within an acceptable range
    • Protection against rodent infestation


Even after a study has been archived, the study and its archiving premises can be inspected by regulatory authorities (e.g. Swissmedic).

What do I need to do?

As a SP-INV define archiving guidelines in a SOP or WI. Ensure guidelines comply with regulatory requirements and are followed by all participating study sites.

As a SP-INV:

  • Define archiving responsibililties
    • The SP-INV archives SP-INV relevant documents at the SP-INV site (e.g. TMF)
    • The Site-INV archives site-specific documents at the study site (e.g. ISF, participant indentification-log and medical records)
  • Pre-approve any archiving procedures defined by the study site (e.g. Site-INV)
  • Make sure the Site-INV:
    • Knows the required study archiving period
    • Is able to guarantee optimal archiving conditions during the entire archiving period
    • Uses a tracking system that records any documents retrieved and returned from the archive
  • Inform the Site-INV(s) of any upcoming regulatory inspection regarding an archived study and/or archiving premises (e.g. inspection of the study or inspection of archiving premises)


In order to facilitate archiving management, place paper documents and materials in study boxes and clearly label boxes for easy identification (e.g. name of study, SP-INV and Site-INV contact information, date of archiving, indication of content, end date of archiving).

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

  • 4.9.5 Site-INV archiving
  • 5.5.7 SP-INV archiving
  • 8. Essential documents for the conduct of a clinical trial

ISO 14155 Medical Device – see in particular section (access liable to costs)

  • 8.6 Document retention
  • Annex E: Essential clinical investigation documents

Swiss Law

ClinO – see in particular article

  • Art. 38 Notification upon study completion, discontinuation, or interruption
  • Art. 45 Data Retention Requirements
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organisation for Standardisation
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
  • WI – Working Instruction
Completion ↦ Monitoring ↦ Close-Out Visit ↦ Archiving

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device

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

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Monitoring ↦ Close-Out Visit ↦ Archiving

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