What Counts as Pharmacy Source Data

Part of Trial Pharmacy (PHARM) Training: Pharmacy Documentation.

About 2 minutes. Free, in your language, no account needed.

Why this matters

Source is the first place something was written down. In pharmacy that is usually a log, a worksheet or a temperature record.

If the source is thin, nothing downstream can be relied on, whatever the database holds.

Pharmacy source records

Receipt records. Temperature logs. The accountability log. Dispensing records. Preparation worksheets with calculations. Returns counts. Destruction records and certificates. Randomization documentation where pharmacy holds it.

Each is source for a different question, and a monitor will follow one participant across several of them.

ALCOA+ in a pharmacy

Attributable. Initials on every entry, and a signature log that identifies whose they are.

Legible. Including after photocopying, which is how most of these are transmitted.

Contemporaneous. At the time of the movement.

Original. The worksheet you wrote on, not a neat copy.

Accurate. Including the inconvenient numbers.

A signature log that maps initials to names is required and routinely forgotten until a monitor asks.

Do not keep a neat copy

Transcribing a working record into a tidy version and discarding the original destroys the source.

The messy worksheet with the crossings-out is the record. The tidy one is a summary, and if the original is gone the site cannot show what it actually did.

Worksheets are source too

A preparation worksheet showing the calculation, the inputs and both initials is source data for the dose.

Keep them with the study records, not in a drawer that gets cleared. Many sites file dispensing records diligently and discard the worksheets that justify them.

In practice

You prepare a dose, calculate on a worksheet, cross out an error and correct it, and both checkers initial.

The worksheet goes into the pharmacy file exactly as written. You do not rewrite it because it looks untidy before a monitoring visit.

What this looks like when it goes wrong

A pharmacy keeps temperature readings on a whiteboard and transfers them to the log weekly.

The whiteboard is the original and it is erased each week. The log is a transcription, and the site cannot evidence storage conditions for any period.

Key takeaways