What is it? Why is it important?

Upon study end, all data, essential documents and other relevant documents are archived. This is necessary for each single study step to be reconstructed at some later date.

It is required that after study completion / discontinuation / interruption, the study is archived for a predefined period.

The archiving period in Switzerland is at least:

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

For international studies where other laws require longer storage durations, the longest storage duration is decisive.

What do I need to do?

As a SP-INV:

  • Check the required storage duration of your study. Retention periods can differ according to study type, involved countries and applicable laws
  • In the event of an international study, check international archiving laws and implement the more stringent archiving requirements
  • Take the duration of liability coverage into consideration (e.g. set at a minimum of 10 years)
  • Inform and train participating Site-INV(s) on the duration and conditions of study archiving requirements

As a Site-INV retain as required after the conclusion or termination of the study:

  • All documents needed to identify and provide post-study care to study participants, including potential damage claims
  • All other original study data

Where can I get help?

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

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 812.21 TPA

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
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EU – European Union
  • FEDLEX - Publication Platform for Federal Laws
  • HRO – Human Research Ordinance
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TPA – Therapeutic Products Act
Completion ↦ Ethics and Laws ↦ Archiving ↦ Duration
Study
Basic

Provides some background knowledge and basic definitions

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

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

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
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

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

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
Completion

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 ↦ Ethics and Laws ↦ Archiving ↦ Duration

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