Writing It Down While You Remember It

Part of Sub-Investigator (SUBI) Training: Contemporaneous Source Documentation.

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

Contemporaneous means at the time

Not the same day if you can help it, and not the same week. A note written while the consultation is fresh contains detail that a later note cannot recover.

The source document is the first place it was written

Usually the medical record. The case report form is generally a transcription of it, not the original.

Data recorded straight into a CRF with no source is a common finding, because there is then nothing to verify against.

Write for a reader who was not there

A stranger, years later, deciding whether your judgment was reasonable on the information you had.

That means the finding, the reasoning and the action. "Continued on study" is a decision. "Grade 1 rash, no mucosal involvement, no systemic features; continued on study with review in one week" is a decision somebody can evaluate.

Give numbers and times

"Febrile" is weaker than "38.9 at 14:10". Numbers survive translation and time; adjectives do not.

Corrections follow the standard

One line through, the original still legible, the correct value, your initials, the date and the reason. Never obliterate, never overwrite, never use correction fluid.

In an electronic record the audit trail does this, provided you give a reason.

Never write for somebody else, and never let them write for you

A note signed by you is a statement that you made those observations.

Late entries are labeled late

An entry made three days afterward is written as such: the date of the entry and the date of the events. That is honest and acceptable.

An entry that implies it was contemporaneous when it was not is a data integrity problem.

If it is not written down

The default assumption at an inspection is that it did not happen. That is not cynicism; it is the only workable rule when the only evidence is the record.