Nursing staff will have to fill in a specially developed documentation sheet in case of a fall event, also a documentation sheet on measures used to prevent falls once a month.
Competent authorities and sponsor authorised persons (auditor) may request access to all source documents, CRF and other trial documentation in case of an inspection or audit.
Maintaining an overview and ensuring transparency may be problematic in all types of models in case of poor model implementation and documentation.
In case of suspected aspiration pneumonia, a microbiological documentation was performed before initiation of probabilist treatment with amoxicillin-clavulanate.
In case of any undetected ad fraud issues, documentation will help identify gaps in policy/procedure to ensure it doesn't happen again.
In case of undocumented symptoms suspicious for arrhythmia recurrences, documentation by additional external ECG event recordings was performed.
In case of an audit, the investigators must make all study documentation available to the auditor.
Furthermore, all patients were advised to present immediately in case of symptoms suggestive for arrhythmia recurrence and obtain ECG documentation.
Examples of deviation from usual professional care are: no fetal monitoring in case of vaginal blood loss, no consultation or action undertaken in case of decreased fetal movements, no further diagnosis and/or action in case of presumed growth restriction and insufficient documentation in the medical records (medication, diagnostic considerations and policy).
One GP forgot the documentation in cases of urgency home visits.
Documentation of conjunctival forniceal foreshortening in cases of progressive cicatrising conjunctivitis (PCC) is important in ascertaining disease stage and progression.
