DOCUMENTATION BASICS

Clear records.
Reliable research.

A starting point for conversations about clinical research documentation. Always follow the protocol, approved procedures, and training for your role.

A practical documentation checklist

Who and when

Make it clear who recorded an activity and when it occurred.

Clear and accurate

Record observations factually and legibly. Avoid guessing or changing the meaning of what happened.

Complete and traceable

Keep required context and preserve the history of corrections using the approved process.

When something needs correction

Follow your site’s documented correction procedure. Preserve the original information and make the correction traceable. If you are uncertain, ask the appropriate supervisor before proceeding.

Describe an event using the facts available. Do not substitute a more favorable explanation for what was observed or reported. A note-to-file should not replace a required record or correction.

This introduction does not replace role-specific training or the procedures that govern a study.

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