A note to file explains something the record cannot explain on its own: a gap, a late entry, an oddity a monitor would otherwise have to guess about. This template gives you the fields, a filled-in example and the limits of the tool, so the note clarifies the file instead of making it worse.
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Header: study, site, NTF number, date
Subject of the note
Delegation log, missing date
What happened, with dates
Cause and impact
Impact on subjects: none
Correction and prevention
Signature and filing location
Key points
Definition
A note to file is a short document, kept in the investigator site file or the trial master file, that records an explanation for something the formal records do not capture. Typical subjects are a missing or illegible entry in a log, a source document that was lost and reconstructed from other records, a sample temperature excursion with no protocol deviation attached, a visit that happened outside the usual process, or a reason why two documents disagree.
ICH E6 does not use the phrase as a defined form, so do not search the guideline for a section to cite. What it does require is the principle behind the note: a record that is attributable, legible, contemporaneous, original and accurate, with changes that are traceable and explained. Under E6(R2) 4.9.3, any change or correction to a CRF should be dated, initialled and explained if necessary, and should not obscure the original entry. Section 4.5.3 expects deviations from the protocol to be documented and explained. E6(R3) carries the same ideas forward with different numbering, so check the current text for the section you cite.
The note is therefore a supporting tool. It sits next to the correction, the deviation report or the log entry. It does not stand in for them. A monitor reading an NTF should be able to find the thing it explains, see what was done, and see who decided.
A correction changes a record so that it is right. A deviation records that the protocol, GCP or a procedure was not followed. A note to file explains context. Many issues need more than one: a visit performed three days outside its window needs a deviation report, and may also need a note explaining that the participant was hospitalised. If a note is the only thing you wrote, ask whether something else was owed. The protocol deviation tracking guide and the severity classifier cover the deviation side.
The template
Copy the left column into your document template. Keep it to one page where you can. A note over two pages usually covers more than one issue and should be split.
| Field | What to write | Guidance |
|---|---|---|
| Study and protocol | Protocol number and short title. | As on the protocol title page, so the note files correctly. |
| Site and investigator | Site number, institution, principal investigator. | The investigator is accountable for the site file even when staff write the note. |
| NTF number | Running number per site, for example NTF-007. | Keep a short index at the front of the NTF section. |
| Date written | The real date, never an earlier one. | If the event was earlier, put that date in the narrative. |
| Subject of the note | One line: what the note is about. | One issue per note. |
| Subject or record affected | Coded subject ID, document name or version, visit. | Never a participant name. |
| What happened | Facts only, in time order, with dates. | No opinions, no blame, no guesses stated as facts. |
| Cause | Why it happened, if known. | Say "cause not established" if it is not. Do not invent one. |
| Impact | Effect on subject safety, rights, data integrity, protocol compliance. | Say who assessed the impact. Escalate if it is more than minor. |
| Correction | What was done to fix the record, and where. | Reference the corrected entry and the date it was corrected. |
| Prevention | What changes so it does not recur. | Training, a checklist, a changed process. "Will be more careful" is not an action. |
| Related documents | Deviation number, query ID, SAE number, email reference. | Lets a reader follow the thread. |
| Author | Name, role, signature, date. | The author should be on the delegation log for the activity concerned. |
| Reviewer or investigator | Name, signature, date. | Investigator review for anything affecting subjects or eligibility. |
| Filing location | Section of the ISF or TMF where it is stored. | File it with, or cross-referenced to, the record it explains. |
Adapt to your sponsor or institution SOP. If a sponsor supplies its own NTF form, use that form and use this table to check that it covers the same ground.
Worked example
Here is a short note about a common finding. Every name, number and date is invented.
NTF-007. Study DEMO-101, Site 003. Subject of the note: missing start date for one team member on the delegation log. What happened: during a self-check on 14 September, the research nurse (RN-02) was found to have signed the delegation log on 2 September with the start date left blank. The nurse took part in the site initiation training on 1 September and first performed vital signs on a participant on 4 September. The investigator countersigned the log on 3 September. Cause: the start-date column was not mentioned on the log completion instructions given at initiation. Impact: the nurse was trained and was performing a task already delegated in the study plan; no data were affected, and no participant was exposed to additional risk. The investigator confirmed on 14 September that the delegation was intended from 2 September. Correction: the nurse added the start date of 2 September with a dated initial and the note "date omitted at signing, see NTF-007"; the original entry remains visible. Prevention: the log completion instructions now name the start-date column, and the coordinator checks it at each signature. Related: self-check record 14 September. Signed: author and investigator, 14 September.
What makes this note work is what it leaves out. It does not backdate the delegation, it does not argue that the omission did not matter, and it does not hide the original blank. It states when the authority was given, what was done afterwards and what changes. A monitor can read it in a minute and move on. For the log itself see the delegation log template.
Facts
Dated
Impact
Assessed
Open
1
In the free sandbox you can test how a change to a form entry carries its reason in the audit trail, so a note to file is only needed for what the data itself cannot say.
Choosing the tool
| Situation | Use a note to file? | What to do instead or as well |
|---|---|---|
| Entry missing from a log, with the facts known and no safety impact | Yes | Add the entry with the real date, and explain in the note. |
| Data value is wrong in the CRF | No, correct it | Change the CRF value with a reason; the original stays in the audit trail. |
| Visit outside the protocol window | Only as context | Record a protocol deviation; add a note only if more explanation is needed. |
| Informed consent missing, outdated or signed incorrectly | No | Treat as a deviation or potential serious breach and escalate to the sponsor and ethics as required. |
| Suspected serious adverse event | No | Report under the protocol timelines; see the SAE report form template. |
| Document lost and reconstructed | Yes | State clearly that the copy is reconstructed, from what, and who certified it. |
| Staff member signed a document before being delegated | Yes, with a deviation | Report the deviation and explain the timeline in the note. |
| Same issue keeps recurring | Not another note | Find the cause, train, and change the process. Open a corrective and preventive action if your SOP has one. |
| Explaining a protocol that is unclear | No | Ask the sponsor for a clarification letter or an amendment. |
The right-hand column is a prompt for judgement, not legal advice. Your sponsor SOP and local rules decide.
How to write one
Before you write, ask whether the issue needs a data correction, a deviation, a safety report or an escalation. Do those first or alongside.
Gather dates, document versions, who was present, and the source. If you are not sure, say what you do not know.
Short sentences, no adjectives, no blame. One issue per note.
Safety, rights, data integrity, protocol compliance. If the impact is more than minor, the investigator should assess it and sign.
Both, each as a concrete action with a date and an owner.
Author signs and dates on the day of writing. The investigator reviews. File with the record it explains and list the number in the NTF index.
In Capture
Capture is an all-in-one clinical trial platform. When a value in a form is wrong, the fix belongs in the form: the field-level audit trail records the timestamp, the user, the old value, the new value and the reason for change, and the trail cannot be modified through the UI. Edit checks raise an auto-query when a value breaks a rule, so many issues are resolved as queries rather than needing explanatory notes. Notes to file then stay for what only a human can explain.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Before you sign
Split anything that covers two subjects or two events.
Date of writing is real; event dates are in the narrative.
No blame, no speculation stated as fact.
Corrections visible, never overwritten or removed.
No participant names or contact details.
Investigator signs if subjects or eligibility are touched.
Both correction and prevention.
Deviation, query or SAE numbers listed; filed with the record it explains.
Inspection readiness
A monitor looks at notes for two things: whether the explanation is believable, and whether the same explanation appears too often. One note about a missing date is ordinary. Twelve notes about missing dates tell the monitor that the process is not working, and the question moves from the log to the training. Under the monitor duties in E6(R2) 5.18.4(n), the monitor also checks that corrections are made by the investigator or an authorised member of staff and that the authorisation is documented, so make sure the author of a correction appears on the delegation log.
Keep an index at the front of the NTF section: number, date, subject, related deviation. Read it before each visit and look for patterns. If your study uses a monitoring visit report, cross-reference notes to the finding they close. For the file structure that holds them, see the investigator site file index template, and for a wider view of readiness the FDA inspection checklist for clinical trial data.
A note to file is a dated, signed memo kept in the site or trial master file that explains something the formal records do not explain on their own, such as a gap, a late entry or a reconstructed document. It states the facts, the impact and what was done about it.
ICH E6 does not define a note to file as a named document in the sections we reviewed. It does require records to be accurate and traceable, and changes to be dated, explained where needed, and not to hide the original (E6(R2) 4.9.3). The note is a common way to meet that. Check your sponsor SOP and the current guideline text.
No. Correct the value in the CRF with a reason, so the original is preserved and the change is attributable. A note may add context, but it is not the correction.
No. A deviation report records that the protocol or a procedure was not followed. A note explains context. Some events need both. Follow the deviation process in your protocol and SOPs.
Never. The date of writing must be the real date. Put the date of the event in the narrative. Backdating turns an explanation into a data integrity problem.
The author signs and dates, and the investigator reviews and signs where the issue touches subjects, eligibility, safety or investigator responsibilities. The author should be someone on the delegation log for that activity.
There is no number, but repeated notes about the same issue point to a process failure. Fix the cause, train the team, and note the change rather than writing another explanation.
No. Capture records corrections with a reason in the audit trail and raises queries from edit checks, which reduces the need for notes. The note itself is a document you write and file.
Keep exploring
Delegation log template
Who may sign and correct.
Protocol deviation tracking software
When a note is not enough.
Monitoring visit report template
Where findings and notes meet.
Investigator site file index template
Where notes are filed.
Audit trail software for clinical trials
Corrections with a reason.
SOP templates pack for clinical research
The SOP that governs notes.
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