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 in the NIH/NCCIH memo format 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:
- Institution letterhead space — a placeholder area at the top for your logo or letterhead
- Memo header — date, to (protocol / study file), from (author name, title, and affiliation)
- Issue — a bordered writing block for what happened, when, and to whom
- Root Cause — a bordered writing block for the underlying reason, not just the surface event
- Corrective Actions — a bordered writing block for the fix, who directed it, and any recovery plans for incomplete records
- Resolution — a bordered writing block for how the fix was documented and closed out
- Effective Date of Resolution — a dated field for when the corrective action took effect
- Comments — a bordered writing block for anything else worth noting for the file
- Signature block — author and Principal Investigator, with dates
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.
