What is it? Why is it important?

Archiving the study database makes its information accessible for potential future use.

A request to access archived data might arise from:

  • A request for data sharing
  • Safety concerns which requires that study participants be re-contacted
  • Allegations of fraudulent behaviour
  • Inspections by EC/RA

Archiving is not limited to the study database and its CDMS but include all records that describe the method, conduct, and results of a study (e.g. study protocol, essential documents, monitoring reports, statistical analysis). In addition, faced challenges and their implemented control measures must be traceable (e.g. study QMS, risk assessment and control measures)

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).
  • In the event that electronic data or documents must be transferred to  a new or more current medium, its transfer system must be validated
  • The archive remains accessible during the entire archiving period but with restricted access control. Restricted access prevents theft, vandalism, forgery, destruction and loss of records
  • Only authorised study staff retain access to archived study records
  • Removing records from the archive is documented and traceable including its return in due time
  • Archiving premises are safe and secure with ongoing protection against fire, humidity, and rodent infestation

 

If requested, all study records must be made available to EC/RA upon demand (e.g. audit or inspection)

What do I need to do?

Provide the Site-INVs with an archiving SOP that defines

  • Requirements for archiving premises (e.g. access control, ongoing protection against fire, humidity, and rodent infestation)
  • What study records to be archived
  • The process on how to archive electronic data including how to ensure data legibility over the entire archiving period
  • Means of document retrieved and returned records
  • Expected duration of archiving.
  • Destruction procedures (e.g. certification of destruction)

Notify the site when the archiving period has ended, and the documents can be destroyed

 

*For more information* refer to Documents in this Trial Guide.

More

The required archiving period depends on study type. After the completion or discontinuation of a study archiving comprises at least:

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

 

Additional archiving guidelines:

    • 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” – Overview of clinical data archiving regulations

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
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • GCDMP – Good Clinical Data Management Practice Guide
  • ODM  – Object Data Manager 
  • pCRF/eCRFs – paper Case Report Form/ electronic Case Report Form
  • Site-INV – Site 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
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 ↦ Data Handling ↦ Archiving ↦ Requirement

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