What is it? Why is it important?

The Patient File (PF) is a folder that summarises all data about a patient’s medical history irrespective of disease and treatment.

contains health related medical data, and consequently the SD of a study participant such as:

  • Diagnose(s)
  • Treatment plans and records
  • Medical reports
  • Medication and treatment history
  • Laboratory and imaging results
  • Questionnaires
  • Participant contact data
  • PIS and ICF
  • Administrative information (e.g. invitation to study visits, expense payments)

PF documents:

  • Are kept in a separate folder and are not part of the TMF/ISF
  • Must always remain at the study site, and only made available to external monitors for SD verification during monitoring visits
  • Are kept current and are continuously updated during study conduct

More

The PF:

  • Summarises all data about a patient’s medical history irrespective of disease and treatment
  • Documents all study related activities
  • Is the property of the study participant, who can anytime request insight
  • Nowadays, PF is mostly electronic and stored in the hospital electronic system

What do I need to do?

Based on data protection laws it is required that:

  • Persons granted access to a PF are:
    • Treating physicians or a health care workers needing information for treatment decisions
    • Members of the study staff who have been authorized according to the delegation-log of the study
    • Study monitors/ auditors/ inspectors
  • Copies of PF documents can only be made when initially authorised by the Site-INV
  • Documents forwarded to persons or institutions outside the hospital require initial approval by the study participant
  • Any entries and modifications made to the PF must be traceable (dated and signed).
  • Old entries that are changed or corrected must remain identifiable

Electronic systems guarantee traceability through the incorporation of an activated audit trail (e.g. who enters or changes when, what data).

More

In the PF:

  • Ensure to document the name of the study
  • Note down when (date) the participant was informed about the study and when (date) the participant consented to take part in the study (e.g. document ICF procedures in the study protocol, a SOP or WI)

Where can I get help?

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

Abbreviations
  • CTU – Clinical Trials Unit
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • PF – Patient File
  • PIS – Participant Information Sheet
  • SD – Source Data
  • Site-INV – Site Investigator
  • TMF – Trial Master File
Conduct ↦ Documents ↦ Required Documents ↦ Patient File
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): Conduct ↦ Documents ↦ Required Documents ↦ Patient File

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