November 2024 SOCRA Source Journal - Journal - Page 30
at the clinical research site.
The monitor, however, should
not take responsibility for the
documentation. The note
should be attributable to the
staff member. An NTF does not
eliminate the need to document
and escalate protocol deviations.
More Examples of NTFs
The following two examples
illustrate what should be
captured in NTFs. The 昀椀rst
example acknowledges missing
documentation from the
Clinical Trial Application (CTA)
classi昀椀cation forms for countrylevel amendments. This note is
more complete than the second
example and contains more
identifying information about
the study and document type.
Example 1: Acknowledges
Missing Documentation
Re: ABC0000123 CTA
Amendment classi昀椀cation
form
Document type: 123.45
Note to File (Country level
documents)
From: Jane Doe, Sr.
Regulatory Analyst, CRO
Date: 15-Aug-2023
This is a note to 昀椀le regarding
the absence of the CTA
classi昀椀cation forms for country
level amendments made in:
• Germany, June 2011
• Italy, June 2011
After efforts to locate the
required documentation, it
has been determined that
the local CTA amendment
classi昀椀cation forms required
for study ABC0000123 cannot
be located in any repositories.
Example 2: Capturing New
Study Information
It is always necessary, however,
to follow the standard operating
procedures for the clinical
research site and the clinical trial.
According to ABC123
protocol, the study drug will
be obtained from commercial
sources directly by sites. In
special circumstances, Drug
Company X may supply
commercial study drug. In
Thailand, Drug Company X
supplies commercial study
drug including 昀椀lm-coated
tablets, (50mg, 200mg)
and powder for solution for
infusion, to the site.
The following example of a note
documenting extemporaneous
information about the site
selection form and use of
contract research organizations is
unnecessary. Also, this note does
not meet Good Documentation
Practice requirements:
In this second example, this
note is used to capture new
study information that was
not documented elsewhere.
While not as thorough as the
previous example, it still contains
information about the protocol
and new methods of obtaining
the study agent.
Depending on the software
being used at the organization,
or whether the organization
is paper-based, some of the
information may already be
captured as part of the software
or the template. Therefore, it
may be necessary to further
capture this information in the
electronic data management
system or the Trial Master File or
to scan and upload a hard copy.
What Notes to File should
not be captured
Some types of NTFs should not
be 昀椀led in the Trial Master File:
•
•
•
30
Note to 昀椀le
From: Jane Doe, Study
Manager
Date: 15-Aug-2023
Notes about missing
documents that are not
relevant to the study or the
clinical research site
Insigni昀椀cant or irrelevant
notes
Notes with details that have
been fully documented in
other study documents.
SOCRA SOURCE © November 2024
Note to File
Study ABC123 did not use the
昀椀nal site selection form since
it is not applicable to studies
utilizing only outside CRO
Clinical Research Units.
~Study manager
Revisiting an Earlier Example:
What it should have looked like
This revised NTF shows how the
昀椀rst example should have been
written. It provides the necessary
information to understand why
the subject was not dosed and
continues the subject’s story
during the clinical trial. This note
includes the protocol number
and title, the author, 昀椀ling
information, study information,
and a better explanation of why
the note was necessary.
PROTOCOL #: 2019-ABX001
TITLE:
The Effect of
‘Investigational Product’ on
XYZ Levels in Healthy Controls
From:
Jane Doe,
Research Coordinator
To:
Subject File; study
communication section
Re:
Subject# 015-N.B.
Date:
October 31, 2011
At visit on 30 OCT 2011, subject
015-NB did not receive dose of
Agent, 10 mg, due to subject’s
febrile state (102° F). Dr. Cardio
instructed no dosing per phone
instructions at that time. Willa
Smith, NP, referred subject to
his primary care physician for
