What is it? Why is it important?

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


The required archiving period depends on study type. In Switzerland the minimum archiving period for:

  • ClinO and ClinO-MD studies is 10 years
  • ClinO-MD studies with implantable medical devices is 15 years
  • TPA / ClinO studies with standardised transplants or studies with blood and blood products is 30 years
  • HRO research projects is 10 years
  • The EU may extend the storage duration for up to 25 years


In the event of an international study having alternative archiving periods, requires that the longest archiving period becomes binding.

What do I need to do?

As a SP-INV:

  • Based on your study, define the required archiving period
  • In the event of an international study, check international archiving laws and plan for the most stringent archiving period
  • Ensure that the study`s liability coverage is taken into consideration (e.g. set at a minimum of 10 years)
  • Ensure archiving premises remain acceptable over the planned archiving period (e.g. access control, fire-, humidity-, rodent protection)
  • Ensure potential study sites comply with the defined archiving period


As a Site-INV ensure to retain at the study site documents needed for:

  • The identification of study participants (e.g. participant identification-log). Post-identification might become necessary in the scope of ongoing participant treatment or potential damage claims
  • All other original study data (e.g. source data)


In the event:

  • Of leaving the institution, hand over the TMF (SP-INV) / ISF (Site-INV) including archiving responsibilities to a delegated person
  • Outsourcing archiving responsibilities, ensure to set up a contract that covers all required archiving aspects

Where can I get help?

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

Swiss Law

ClinO– see in particular article

  • Art. 45 Data retention requirements

ClinO-MD – see in particular article

  • Art. 40 Document retention requirements

TPA – see in particular article

  • Art. 40 Obligation to archive

FADP  -  see in particular

  • Art. 5d data processing
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EU – European Union
  • FADP – Federal Act on Data Protection
  • HRO – Human Research Ordinance
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TPA – Therapeutic Products Act
Completion ↦ Ethics and Laws ↦ Archiving ↦ Duration

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 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 Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Ethics and Laws ↦ Archiving ↦ Duration

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