February 2025 SOCRA Source Journal - Journal - Page 43
study are conclusively related
to the intervention and not
other factors. Therefore, their
veri昀椀cation is leaned on heavily
during regulatory visits and
inspections. See this excerpt
from an FDA Warning Letter
as proof of the importance of
verifying eligibility: “Enrollment
of subjects who do not meet
eligibility criteria…jeopardize
subject safety and welfare and
compromise the validity and
integrity of the data collected at
your clinical research site.”
The checklist used should be
study-speci昀椀c, matching the
current version of the protocol,
and listing all criterion separately
(see Diagram 6 on next page).
Each criterion should be veri昀椀ed
prior to the performance of
any study-speci昀椀c activities
(including randomization) by
direct comparison with source
documentation (e.g., pathology
or laboratory test results,
physical exams, outside records).
In other words, it is not enough
to rely on “yes” and “no” check
boxes with a general “blanket”
statement such as, “The subject
does/does not meet the
inclusion or exclusion criteria
outlined in the protocol.”
You must have proof to con昀椀rm
each item on the checklist.
As with the completion of
the ICF, the staff member
reviewing subjects for eligibility
and completing this checklist
should be quali昀椀ed, delegated,
and trained. Depending on
the clinical research site and
Sponsor, the checklist may
have multiple signature lines
as a “check and balance”
multi-layer validation system
(i.e., coordinator, nurse,
Investigator, etc.). Often, the
clinical investigator is required
to sign/date the checklist for
con昀椀rmation of eligibility, as well
as documentation of oversight.
Diagram 4
Diagram 5
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