August 2024 SOCRA Source Journal - Journal - Page 57
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Diagram 18
Other, to be speci昀椀ed in
the log
Common codes for “Informed
Consent/Randomization” are:
• Failing to obtain or
document informed consent
prior to initiation of study
procedures
• ICF used was not the current
IRB-approved version
• Non-delegated staff
member performs the
informed consent process
• ICF is not signed and/or
dated by subject
• ICF is not signed and/or
dated by staff member
(if required)
• Failing to provide subject
with a copy of the ICF
• ICF is missing from 昀椀les
• Other, to be speci昀椀ed in
the log
Diagram 19
Common codes for “Eligibility”
are:
• Subject did not meet
eligibility criteria(on)
• Randomization of an
ineligible subject
• Subject randomized prior
to completing baseline
assessments
• Randomization and/or
treatment of subject prior
to IRB approval of protocol
• Other, to be speci昀椀ed in
the log
Common codes for “Study
procedures/Visit schedules” are:
• Subject received the wrong
treatment
• Conducting a study visit
outside of the required
timeframe
• Missed assessment or visit
• Performing a study
procedure not approved by
the IRB
• Failing to perform a
required test
• Exceeding approved
enrollment numbers
Less common contents for Deviations Logs may be fields for protocol version (helpful when determining
whether a missed lab or test was indeed required at that time point) and whether the deviation resulted in
an AE or subject drop-out (helpful when tracking safety, outcomes and Unanticipated Problems Involving
Risks to Subjects or Others [UPIRTSOs]).
23
•
•
Less common contents for Deviations Logs may be fields for protocol version (helpful when determining
whether a missed lab or test was indeed required at that time point) and whether the deviation resulted in
an AE or subject drop-out (helpful when tracking safety, outcomes and Unanticipated Problems Involving
Implementing
unapproved
• AE/SAE/UADE not reported
Risks
to Subjects or Others
[UPIRTSOs]).
recruitment procedures
Other, to be speci昀椀ed in
the log
Common codes for “Safety” are:
• Dispensing or dosing error
for study medication
• Prescribed dosing outside
protocol guidelines
to the IRB within protocol-
23 mandated timeframe
•
•
Failing to report UPIRTSO
to the IRB and Sponsor (if
applicable)
Other, to be speci昀椀ed in
the log
SOCRA SOURCE © November 2024
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