Permission for the interview and written or tape-recorded informed consents will be taken.
The state said it had also recommended that Dr. Hall inform new patients of his infection and have an impartial witness record their informed consent.
Consistent with California State law, clinicians were required to document in the medical record that informed consent was obtained, but a patient's signature was no longer required [4].
Adverse events will be recorded form signed informed consent until the last follow up visit (end of study) Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning or detected through physical examination or laboratory tests will be collected and recorded.
To enable peer review and/or inspections from Health Authorities, the principal investigator will keep records, including the identity of all participating subjects (sufficient information to link records, e.g. CRFs and hospital records), all original signed Informed Consent Forms and copies of all CRFs, for 15 years.
At screening, investigators will describe the study in detail, obtain written informed consent, record demographics, collect relevant medical history/lifestyle activities, perform physical examinations, collect laboratory samples, and document all current medications, including vitamins and supplements.
Data was collected using voice recordings from three different activities: All clinical appointments were voice recorded with prior written informed consent from patient and physician.
All sessions are audio recorded with participants' written informed consent.
Interviews were digitally recorded with the participants' informed consent.
Interviews were recorded and transcribed with participant informed consent.
