Free GCP Note to File Template
The GCP Note to File Template
A free template for the moment something happens that your standard study documents can't fully explain.
Well-written NTFs support the trial master file. Poorly written ones create more questions than they answer. This template is structured to make writing a good NTF the path of least resistance — neutral, factual, and complete.
One page. Editable Word and print-ready PDF.
What's inside:
- Header info block — protocol ID, date created, site number, subject ID (if applicable), author name and title
- Issue / Discrepancy Description — a bordered writing block with in-place guidance for staying objective
- Root Cause & CAPA — a bordered writing block for the why, the immediate action, and what prevents recurrence
- Signature block — author, and PI where required
Use it when an existing study document can't fully capture what happened. Not a substitute for a source document. Not a way to explain away deviations after the fact.
Free to download. Built by The CRC Toolkit.
