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.
A PF contains health related medical data, and consequently participant Source Data (SD) to be used in studies, such as:
- Treatment plans and records
- Medical reports
- Medication and treatment history
- Laboratory and imaging results
- Participant contact data
- PIS and ICF
- Administrative information (e.g. invitation to study visits, expense payments)
- 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
- 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 (e.g. CDMS) guarantee traceability through the incorporation of an activated audit trail (e.g. who enters or changes when, what data).
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch