Your Easy Guide to Clinical Studies

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

 

A PF contains health related medical data, and consequently participant Source Data (SD) to be used in studies, such as:

• Diagnoses 
• 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

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

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