November 2024 SOCRA Source Journal - Journal - Page 31
treatment. Scheduled visit for 2
NOV 2011, still in visit window.
Jane Doe
Comparing this note with the
initial note shows that the
subject did not receive the
study agent due to their medical
status. A back-up research
coordinator or treating physician
would know how to proceed
with the information provided.
This incident appears to have
been handled correctly and
requires no corrective action.
Notes that expose issues with
study procedures, training,
or other elements that are
important for proper study
conduct, however, may require
more information, such as what
will be done to prevent or
mitigate similar incidents in
the future.
Care must be taken when writing
NTFs. During an audit, this
type of note can damage the
organization’s quality system.
This is more serious than having
one incorrect NTF.
Retention and Distribution of
Notes to File
All NTFs should be signed by the
author and kept in the clinical
research site’s regulatory 昀椀le.
They should be made available
to monitors. Depending on the
study, the sponsor’s policies,
the patient population, and the
organization, the documentation
retention policy also applies to
NTFs.
Also, depending on the
procedures in place at the clinical
research site, the NTFs may be
sent to the sponsor, the monitor,
and a data management center.
This is especially true for studies
involving a contract research
organization and large multicenter clinical trials.
TABLE 4
Problems with NTFs Seen During Audits
•
•
•
•
•
•
•
•
Missing signature or job title for the person writing the NTF
Redundant notes to 昀椀le
NTFs written and signed just before an audit or monitoring visit
NTFs not put in the regulatory binder or 昀椀led incorrectly
Unauthorized personnel signing the NTF
Only acknowledge a protocol deviation
Using templates from other studies that have not been updated
Using an NTF for an NTF
Potential Problems with
Notes to File
Problems can occur when
writing these seemingly
innocuous NTFs. Despite the
best efforts of clinical research
professionals, the system for
NTFs may be problematic. For
example, is it suf昀椀cient and
acceptable to create a note
any time a mistake is made or a
document is missing? Or should
notes only be written when a
major issue with Good Clinical
Practice has occurred?
While NTFs are a quick and easy
solution to the lack of adequate
documentation during a clinical
trial, over the years, they have
evolved from a last resort
solution to a common working
practice among clinical research
professionals, bordering on
misuse of the tool. This practice
has become so common that
new study staff may think
that NTFs are a regulatory
requirement. They are not.
Audits and Lessons Learned
from Audits
Table 4 highlights problems with
NTFs the author has seen during
audits. As part of an audit team,
the author veri昀椀es that NTFs
follow Good Clinical Practice.
Some of the issues she has seen
include missing signatures, dates,
or the job title of the person
writing the NTF. Many redundant
notes are completed for the
same issue. NTFs are often
written and signed just before
an audit or monitoring visit,
demonstrating a lack of ongoing
review. Some NTFs are not put
in the regulatory binder or are
昀椀led incorrectly or not at all.
Incorrect personnel signing
the NTF is another common
problem. For example, the
research coordinator can sign
off on notes related to the
regulatory binder, however,
the clinical investigator or their
delegate, as per the delegation
of authority log, must sign notes
related to investigational agent
dosing errors.
Also, NTFs should not only
be written to acknowledge
that a protocol deviation has
occurred. They should explain
the cause of the deviation and
include additional information
or documentation. This
documentation should include
any actions taken to address
any consequences, such as
reporting the deviation to the
institutional review board (IRB)
or the sponsor, or con昀椀rming
that subject safety was not
impacted. The note should also
include any preventative actions
taken to avoid similar deviations
in the future.
SOCRA SOURCE © November 2024
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