November 2024 SOCRA Source Journal - Journal - Page 58
Common codes for “Prohibited
medications or therapy” are:
•
•
Use of unallowed
concomitant medications/
treatments
Other, to be speci昀椀ed in
the log
As with AE Logs, UAMS asks
that study teams use Deviation
Logs that allow the clinical
investigator to con昀椀rm oversight
with their signatures and initials.
The clinical investigator should
periodically review deviations to
track and trend events over time
to look for systemic problems
with the study.
TABLE 8
Deviation Log Contents
•
Common contents:
o Reference number
o Subject ID
o Date of deviation
o Date identi昀椀ed
o Deviation description
o Description of corrective action
o Reporting to Sponsor and IRB
•
Less common contents:
o Protocol version
Good Documentation Practice
Good Documentation Practice
(GDocP) is an important concept
with which to be familiar, as
mistakes are bound to be made
during the transcription process.
Among other best practices,
GDocP describes how to
properly correct errors. First,
the person recording data
should correct the error. If this
is not possible, the supervisor
should make the correction (if
supporting data is available) or
Sponsor procedures should be
followed.
Steps include:
•
•
•
•
•
58
Single line through incorrect
entry (i.e., no write overs, no
scribbling) to permit reading
of original information
Write correct entry near
the error
Record concise explanation
for correction, if necessary
(e.g., date/spelling error,
late entry)
Initial and date correction
Ensure that there is a clear
audit trail for all changes/
revisions
o
Whether the deviation resulted in an AE
o
Whether the subject continued in the study
o
Impact:
-
•
Study validity
Safety
Outcome measures
No Impact
Deviation Log codes include those related to:
o Informed consent procedures
o Randomization procedures
o Eligibility (Inclusion/Exclusion criteria)
o Study procedures
o Visit schedules / Intervals
o Drug/Device regimen
o Reporting of SAEs/UPIRTSOs/UADEs
o Prohibited concomitant medication/Therapy
o Other
Remember that the ALCOA+
principles should always be
followed!
In closing, “It is important
to understand that proper
documentation of a clinical
research trial is not just a
means of organized 昀椀ling
for a multiplying mound of
paperwork. It is a tangible
SOCRA SOURCE © November 2024
trail that tells the story of
the trial from conception
to completion, re昀氀ecting
adherence to applicable
regulations and demonstrating
trial integrity through
transparency.”
— Maddock & York, 2012
