Study Drug Accountability and Pill-Count Compliance (21 CFR 312.62)
Study drug accountability: pill-count compliance per visit and the site balance.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Visits, one per line
- S01-V2, 60, 6, 2026-09-01, 2026-09-29, 2
- Protocol compliance range, lower end
- 80 %
- Protocol compliance range, upper end
- 120 %
Result: 1 visit: compliance 96.4%, 0 outside the protocol range of 80% to 120%.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Visits, one per line: code, dispensed, returned, dispense date, return date, units per day, hold days (optional)
- Protocol compliance range, lower end (optional)
- Protocol compliance range, upper end (optional)
- Site balance: units received
- Site balance: units dispensed
- Site balance: units returned to stock
- Site balance: units destroyed
- Site balance: units returned to the sponsor
- Site balance: count on hand
How this is calculated
Citation
21 CFR 312.62(a): an investigator keeps records of the disposition of the drug, including dates, quantity, and use by subjects. 21 CFR 312.57(a) for sponsors. The compliance and balance formulas are arithmetic on those records. Read the sources: 21 CFR 312.62 ↗, 21 CFR 312.57 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.