November 2024 SOCRA Source Journal - Journal - Page 28
in an existing form or template
that is associated with standard
procedures or an existing
repository or database. If the
answer is yes, an NTF is likely
not required.
Information in an NTF includes
the author’s name and the
date. If the date of the incident
is different than the date the
note was prepared, both dates
should be included. An NTF
should never be backdated,
however, it can reference the
date the situation occurred and
was resolved, as applicable.
Depending on the clinical
research site’s requirements, a
signature may be required.
At a minimum, an NTF contains
the study number and the
name of the clinical research
site and describes whether
the clinical investigator and/or
the monitor was informed and
when it occurred. The issue or
situation should be described,
including any dates, along with
any corrective actions taken and
when they were completed.
The examples used in this article
are real-life examples from audits
or inspections. Here is the 昀椀rst
example of an NTF:
PROTOCOL #: 2019-ABX001
From:
Jane Doe
To:
Subject File
Date:
October 31, 2011
Subject N.B. was not dosed
Jane Doe
In this example, the note raises
more questions than it answers.
For example, the date of the
study visit is missing and there
is no explanation about why the
subject was not given the drug.
Unfortunately, these types of
notes occur. One reason may
be that people tend to write the
way they speak. When clinical
research professionals write a
28
TABLE 1
General Contents of a Note to File
•
•
•
•
•
•
A brief description or outline of the topic, process, or problem
The reason(s) the issue arose
Description of the corrective actions taken or planned
Description of the procedures used to document the resolution
of the problem
Effective date for corrective action
Any additional comments or information not noted previously
TABLE 2
General Principles of a Note to File
•
•
•
•
•
•
•
•
Generated on a case-by-case basis
Include the subject and protocol it refers to
Be signed and dated by the individual who is writing it
Be legible if handwritten
Explain clearly and speci昀椀cally the reason for the error, omission,
or discrepancy, or the process or policy that the NTF aims
to address
Include any corrective action or follow-up, when applicable
Be 昀椀led with the document, subject 昀椀le, or behind the study
binder tab to which it applies
Cannot be removed from of昀椀cial study records
note that is clear to them, it may
not be clear to people who read
it later. Outside staff and auditors
do not have previous information
about the subject or the clinical
trial that would clarify the note.
General Contents and General
Principles of Notes to File
Table 1 highlights the general
content of an NTF. The content
generally includes a brief
description or outline of the
topic, process, or problem and
the reason(s) the issue arose. An
NTF also includes a description
of the corrective actions taken
or planned and the procedures
used to document the resolution
of the problem. The effective
date for the corrective action
and any additional comments or
information not noted previously
SOCRA SOURCE © November 2024
are also included.
General principles of NTFs
(Table 2) include generating
them on a case-by-case basis.
An NTF should include the
subject and the protocol it refers
to, and be signed and dated by
the individual who is writing it. If
the NTF is handwritten, it should
be legible. The NTF should
explain clearly and speci昀椀cally the
reason for the error, omission,
or discrepancy or the process
or policy it aims to address.
Any corrective action or followup, when applicable, should
be included.
NTFs should be 昀椀led with the
document, subject 昀椀le, or behind
the study binder tab to which
it applies. Since study records
