November 2024 SOCRA Source Journal - Journal - Page 27
JOURNAL ARTICLES
Notes to File: Compliant
Practices to Ensure
Data Integrity
Heather Pham, MS, CCRP, CHRC
Clinical Research Educator,
Providence St. Joseph Health
Heather Pham, MS, CCRP, CHRC
Abstract: “Notes to File” are a key tool in clinical research when used appropriately. This article provides an
overview of Notes to File, including their components and how to create a Note to File properly. Current problems
with Notes to File are reviewed and real-life scenarios are presented. Alternatives to Notes to File are highlighted.
Overview of Notes to File
Clinical research professionals use
Notes to File (NTFs) to document
a discrepancy or a problem with
a clinical research study and
plans to resolve the problem
and prevent it from recurring.
Discrepancies and problems
can also be documented as
a Memo to File or a Note to
Study File. These terms are used
interchangeably in this article.
When an event, decision, or
situation requires an explanation
and nothing else is suitable to
capture the explanation, clinical
research professionals should
use an NTF. Each NTF must
include appropriate and relevant
components and not duplicate
information that is already
captured in another document.
For example, a decision that has
already been documented in the
study log and 昀椀led in the Trial
Master File does not require a
note. A NTF can be used to:
•
•
•
•
Document a discrepancy or
problem in the conduct of
a study
Note the root cause of the
problem
Identify the corrective action
taken to prevent recurrence
Document that the
corrective action has
resolved the issue
In general, an NTF should be
forward looking and not written
to explain the error. An NTF
can clarify or add information
on clinical research site-speci昀椀c
昀椀le requirements or source
documents. It should document
any issues related to the
protocol or the clinical research
site that cannot be resolved
without a change in procedures.
Also, keep in mind that these
are general practices, site
speci昀椀c SOPs should detail what
information should be captured
and how.
Protecting subjects and maintaining the integrity of study
data are key reasons for using
NTFs. Documentation must
meet Good Documentation
Practice standards and be easy
for all internal and external staff
to follow.
When the clinical research
site’s system is balanced and
the documentation generated
suf昀椀ciently describes an issue or
the actions that were taken, it is
like managing the “pennies” of
the system. If there is an audit,
the “dollars” will have taken
care of themselves. Depending
on the system being used—fully
electronic, paper-based, or
hybrid—and the site’s resources,
some of the information in this
article may not be applicable.
Components of a Note to File
Before writing an NTF, clinical
research professionals should
determine whether the information can be documented
SOCRA SOURCE © November 2024
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