Source Data, ALCOA+ and the Nursing Note

Part of Research Nurse (RN) Training: Documentation and Inspection Readiness.

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

Why this matters

Source data is the first place something was written down. For much of what you do, the source is your note.

If the note is thin, the trial's evidence is thin, whatever the database says afterwards.

What ALCOA+ asks of a record

Attributable. Clear who wrote it.

Legible. Readable by someone else, later.

Contemporaneous. Written at the time.

Original. The first record, or a certified copy.

Accurate. True and complete.

The plus adds complete, consistent, enduring and available. Together they are simply a description of a record somebody can rely on.

What makes a nursing note good source

It answers who, what, when and on whose authority, without the reader needing to ask you.

"BP 152/94 right arm, seated, 09:12, participant had walked from car park, repeated 09:25 after rest, 138/86" is source data.

"BP slightly raised, settled" is a memory aid.

Do not write only in the database

If a value goes straight into an electronic form with no source behind it, that form becomes the source, and that has consequences for how it must be handled.

Know which of your data is direct-entry and which has a paper or note behind it. Sites get into trouble by assuming the answer rather than checking it.

Avoid the untraceable summary

"Participant well" covers a multitude. So does "no AEs reported."

If you asked and they said no, write that you asked. The difference between "no adverse events reported" and "asked about adverse events; none reported" is the difference between an assumption and evidence.

In practice

You take a set of observations, notice nothing unusual, and the participant says they feel fine.

You still write the values, the time, and that you asked about symptoms and were told there were none. Three lines. It takes twenty seconds and it is the difference between a record and a blank.

What this looks like when it goes wrong

A nurse keeps excellent informal notes on a personal notepad and transcribes them into the file at the end of the week.

The notepad is the original record. It has now been destroyed, and the file contains a transcription written days later.

Nothing was invented. The evidence is nonetheless second-hand throughout.

Key takeaways

• Source is the first place it was written, which is often your note.
• ALCOA+ describes a record someone else can rely on.
• Record that you asked, not only what you were told.
• A transcription made later is not the original.