Guidance on Writing a Note to File
A note to file (NTF) is a way of documenting information to a participant chart or a regulatory binder that does not use a standardized document such as a case report form (CRF). While useful, they should not be overused. This document provides topics to think about when considering writing a note to file.
What is a note to file?
A note to file (NTF) provides a way to document deviations, problems, or events that occur during the conduct of research that cannot be documented in a standard case report form (CRF) or research record. A note to file can also be used to document specific regulatory requirements for a study, such as documenting receipt of new information about an intervention, or cataloging site-specific protocol requirements. A note to file essentially provides a way for a researcher or research team to document information which does not easily fit into other standardized forms. They may be participant specific or study specific, and may be reviewed by study monitors or during audits.
How do I write a note to file?
- A NTF should discuss the issue/process/problem being documented including (if applicable) how, when, and by whom the issue was identified, cause of the issue (if known), and corrective and preventative actions taken (when and by whom). Reasons for any departure from protocol should be documented and attempts to correct or prevent occurrence in the future should be included.
- A NTF should always be signed and dated by the author. The PI may need to sign and date as well depending on the content of the note (ie subject protection, data integrity, etc.)
- Participant NTFs should be labeled with participant number, study name, and date. Study NTFs should be labeled with study name and date.
- While the ICTR NTF template is a good form to follow, a NTF does not need to be created using a particular form. A NTF can be typed in Word or even handwritten on a blank page if something needs to be documented immediately
- A NTF may consist of or include communications or supporting documents (for example, e-mail communication from a provider regarding AE follow-up).
- Once a NTF is written, it is part of the research record. Think twice before you write and file one as an unnecessary or poorly written NTF may create more questions than it answers.
Who can write a note to file?
A NTF can be completed by any designated member of the study team.
When should a note to file be written?
A NTF should be written in a timely manner (within 1 week not 6 months).
Where should a note to file be saved?
Participant specific forms should be saved in the participant's chart. Study specific forms should be saved in the study regulatory binder.
Anything else to be considered?
- NTFs should not be used to correct errors, prevent errors, secure compliance, or escalate non-compliance/protocol deviations. They should not be used to exempt a participant from protocol eligibility criteria or to report a serious adverse event.
- If multiple NTFs are being written for the same problem, take a closer look and evaluate whether a corrective and preventative action plan (CAPA) is needed. If so, include this CAPA information in the NTF.
- A systematic error (ie one that involves several participants) may either be recorded individually in the participants' charts or one general NTF may be written for the regulatory binder, listing the participant number for all impacted.
- NTFs should not be used to excuse poor work, missing data, or inadequate source documents. For example, you should not write a note to file saying a participant's medical history was unavailable for review during assessment for eligibility. If you didn't have that history, you did not properly determine eligibility.
|Version Date||Effective Date||Change Reason||Primary Author|
|July 24, 2020||August 5, 2020||Original||Sandy Harding|