Investigational product accountability
In Running the trial
Also known as: drug accountability
Investigational product accountability is the documented tracking of every unit of study treatment from arrival at a site to its use, return, or destruction. Records must show what was received, what was given to which participant and when, and what remains. Monitors reconcile these records at every visit, and unexplained gaps are treated seriously.
Why it matters
Drug accountability is one of the most common sources of inspection findings, because it is easy to dispense correctly and then record it late or incompletely.
Example
A monitor counts returned tablets, compares them with the dispensing log and the participant's diary, and finds eight tablets unaccounted for \u2014 which must be investigated and explained in writing.
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