All records, in any form (including but not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describes or records the methods, conduct, and/or results of a study, the factors affecting a study, and the actions taken.
Dosing Regimen
The expected amount of study medication prescribed per time unit and duration of dosing (for example, 3 times/day for 7 days of therapy) as required in the study protocol.
