Corrections and the Audit Trail
Part of Trial Pharmacy (PHARM) Training: Pharmacy Documentation.
About 2 minutes. Free, in your language, no account needed.
Why this matters
Pharmacy records are corrected often, because pharmacy records numbers and numbers get mistyped.
How a correction is made is the difference between a credible record and a suspect one.
Paper corrections
Single line through so the original remains readable. Correction beside. Initials and date. A brief reason where it is not obvious.
Never obliterate, never use correction fluid, never overwrite a digit. Changing a 1 into a 7 is indistinguishable from falsification, whatever the intent.
Electronic corrections
Use the system's own edit function so the audit trail captures it. Never share credentials.
An entry made under a colleague's login is unattributable, and attributability is the requirement that the whole record rests on.
Correcting a running balance
A quantity error affects every subsequent balance. Rewriting the whole column looks like a rewritten log.
The usual approach is to correct the erroneous entry properly, then add a dated note explaining the balance adjustment and carrying the corrected figure forward from that point.
Ask the sponsor if the protocol specifies a method; some do.
Late entries
If a movement was not recorded at the time, record it now, dated now, noting the actual date and time of the movement and that it is a late entry.
A labeled late entry is usable. One written into the sequence as though contemporaneous is falsification and the ink, spacing or metadata usually show it.
In practice
You find a receipt logged as 20 units that should have been 30.
Strike through, write 30, initial, date, note "transcription error at receipt, verified against shipping document". Then a dated note correcting the balance from that point.
Three visible marks, and a record that can be followed.
What this looks like when it goes wrong
A pharmacist notices several small errors before a monitoring visit and rewrites two pages of the log neatly, copying corrected values.
The monitor sees two pages in consistent ink with no corrections, surrounded by pages with many. The question is no longer about the quantities.
Key takeaways
- Line through, correct beside, initial, date. Never obliterate or overwrite.
- Never share a login; unattributable entries fail the first ALCOA test.
- Correct a balance with a dated note, not by rewriting the column.
- Label late entries as late.