November 2024 SOCRA Source Journal - Journal - Page 29
are of昀椀cial and NTFs are part of
the study documentation, they
cannot be removed.
Good Documentation Practices
Like other documentation,
NTFs must follow Good
Documentation Practices (Table
3). They are part of the of昀椀cial
study documentation. All records
should be signed and attributed,
dated, and secured. They should
be written in real time and tell
the “story” of the study and
the subjects on that study. If
something is not documented,
then technically, it did not
happen.
21 CFR Part 58 contains the
ALCOA Good Documentation
Practices standards: Attributable,
Legible, Contemporaneous,
Original, Accurate, and
Complete. FDA auditors and
quality assurance professionals
use ALCOA to assess
documentation.
TABLE 3
Good Documentation Practices for Notes to File
•
All records should be:
o Signed and attributed
o Dated
o Secured
o Documented in real time
o Including the “story” of the study
•
Attributable:
o The person who created a record and when it was created
must be clearly documented
o
When a record is changed, it needs to be clear as to who
made the change and why
•
Legible:
o The original data and correction (if any) must be readable
•
Contemporaneous:
o Study information is recorded when observed
•
Original:
o Study records are originals and not copies
•
Accurate:
o Study records are an accurate and honest accounting of
what was observed
o Study records need to be thorough and correct
•
Complete:
o
Study staff need to maintain adequate, accurate and
complete documentation
Documents must be attributable
to the person who created the
NTF and clearly dated. When a
record is changed, it needs to
be clear who made the change
and why. The original data
and correction (if any) must
be legible. Contemporaneous
means that study information is
recorded as it is observed. Study
records must be the originals.
general, missing documentation
identi昀椀ed during a study or a
clinical research site-level review
should be acknowledged and
explained in a single NTF.
Accurate study records are
an honest, thorough, and
correct accounting of what
was observed. All work should
be double checked for errors.
Study records also need to be
complete. Clinical research
professionals need to maintain
adequate, accurate, and
complete documentation.
Clinical research professionals
should avoid creating an NTF,
however, for every single
document, or create NTFs for
documents that are not relevant
to the site. For example, if no
subjects were consented, an
NTF is not needed to explain
why there is no informed
consent log.
Information that is not collected
as part of the study, not entered
into the electronic Case Report,
and not documented elsewhere
should be captured in an NTF. In
The reason for the NTF dictates
who should write it. If the issue
is related to clinical research site
performance, the appropriately
credentialed individual from the
site should write and sign the
NTF. For issues related to clinical
investigator responsibilities such
as human subject protection
or data integrity, the clinical
investigator should write and
sign the NTF. If the issue is
related to actions taken by
the monitor or sponsor, such
as clari昀椀cation of a section of
the protocol, an appropriate
credentialed individual from the
sponsor should write and sign
the NTF.
NTFs should be created and
documented by the individual
responsible for the work that
is involved. For example, a
monitor might assist clinical
research professionals in writing
an NTF related to an issue
SOCRA SOURCE © November 2024
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