What Belongs in the Record

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

About 1 minutes. Free, in your language, no account needed.

More than the protocol asks for

The protocol tells you what data the study needs. The medical record needs enough to show the participant was cared for and the trial was conducted properly.

Those overlap and are not the same, and the second is the wider one.

For each visit

That the participant attended and on what date. The assessments performed, with values. Adverse events, including ones the participant mentioned in passing. Concomitant medication changes. Study intervention given or withheld, with the reason. Your clinical impression and the plan.

Record what the participant told you, as they told you

Their account is data. Paraphrasing into clinical language can lose what mattered.

"I felt dizzy every time I stood up for about four days" is more useful than "reports postural symptoms".

Negative findings are findings

If you examined for something specified and it was absent, say so. Silence cannot be distinguished from not having looked.

The participant is a trial participant, and the record should say so

A note that they are in a trial, which one, and the identifier. Other clinicians treating them need to know, and so does anybody reconstructing the record.

Protocol decisions belong in the medical record too

Eligibility determinations, dose modifications and discontinuation decisions are medical decisions. They belong where a clinician would look for them, not only in study paperwork.

Do not keep a parallel private record

Notes kept separately so the real record stays tidy create two versions of the truth and one of them is undisclosed.

If it informed a decision, it is part of the record.