What is it? Why is it important?

Archiving the study database (eCRF) makes its information accessible for potential future use. A request to access archived data might arise from:

 

Archiving is not limited to the study database and its CDMS, but includes all records that describe the method, conduct, and results of the study (e.g. study protocol, essential documents, monitoring reports, statistical analysis). In addition, a description of the risk management of the study with its implemented risk control-measures must be archived (e.g. risk-based QMS)

More

Archived records can either be hand-written, electronic, magnetic, optical, scans, x-rays, or electrocardiograms.

 

Archiving must guarantee that:

  • Data integrity is maintained with records remaining legible over the entire archiving period (e.g. completeness, legibility, inalterability).
  • Electronic data or documents transferred to another (more current) medium, has its transfer system validated
  • The archive is access restricted but remains accessible during the entire archiving period. Only authorised study staff retain access to the archive. Restricted access prevents theft, vandalism, forgery, destruction and loss of records
  • Records removed or returned from/to the archive are documented and traceable (e.g. dated and signed with details on relevant documents)
  • Archiving premises are safe from any potential damage, with ongoing protection against fire, humidity, and rodent infestation

 

What do I need to do?

As a SP-INV, provide the Site-INV with an archiving SOP that defines:

  • What study records to archive
  • The process on how to archive electronic data
  • Means on how to document retrieved and returned records
  • Expected duration of archiving
  • Expected requirements for archiving premises (e.g. access control, protection against fire, humidity, and rodent infestation)
  • Destruction procedures (e.g. certificate of destruction). Notify the study-site when the archiving period has ended and documents can be destroyed

 

In the event of an audit or inspection during the archiving period, ensure auditors or inspectors have access to all required records on demand.

 

The required archiving period depends on study type, such as:

  • 10 years for IMP studies
  • 15 years for studies with implantable MD
  • 20 years for studies with transplant products, blood or blood products

More

Guidelines for the archiving of study data:

  • Archive all clinical-, meta-, administrative- and reference data in standard open system formats (e.g. CDISC, ODM storing system)
  • Archive all study components including clinical data, CRF (electronic and paper), validation records, and regulatory documentation
  • Store audit trails in open format files
  • Retained in an archive facility copies of all user and system documentation for any applications used to collect or manage clinical data
  • Print and store in a central document library all reports describing the metadata of the study, including data structures, edit check descriptions; lab-loading specifications
  • Archive system security reports, including user listings, access rights and the dates of authorisation

Where can I get help?

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

External Links

GCDMP – see in particular

  • Chapter “Clinical Data Archiving”

CDISC – see in particular

  • ODX-XLM – Vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data

*References

ICH GCP E6(R2) – see in particular guideline

  • 5.5. Trial management, data handling, and record-keeping
Abbreviations
  • CDISC – Clinical Data Interchange Standard Consortium
  • CDMS - Clinical Data Management System
  • CTU – Clinical Trials Unit
  • CRF – Case Report Form
  • eCRF – electronic Case Report Form
  • EC – Ethics Committee
  • GCDMP – Good Clinical Data Management Practice Guide
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMD – Investigational Medical Device
  • IMP – Investigational Medicinal Product
  • ODM  – Object Data Manager 
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • SOP – Standard Operating Procedures
Completion ↦ Data Handling ↦ Archiving ↦ Requirement
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
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
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 Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

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 ↦ Data Handling ↦ Archiving ↦ Requirement

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