November 2024 SOCRA Source Journal - Journal - Page 44
A fully veri昀椀ed Eligibility Checklist
with complete supporting source
documentation can prevent queries
from monitors/auditors about
whether a subject meets inclusion/
exclusion criteria, and more
importantly, avoid major issues with
the FDA and/or the Sponsor.
The Screening and Enrollment
Log(s)
Documentation of Screening
and Enrollment is recommended
as best practice for all studies.
Along with offering a snapshot of
current subjects, the Screening
and/or Enrollment Logs also track
information such as reasons for
screening failures, withdrawals, or
terminations. This information is
helpful in the completion of IRB
continuing review submissions, as
well as the design of future studies.
GCP de昀椀nes Screening Logs
and Enrollment Logs separately,
however, many clinical research
sites combine them into one
document with speci昀椀c codes
or status to indicate the 昀椀nal
placement of subjects (e.g.,
failed screening/screening failure,
subject withdrawal/consent
withdrawal, clinical investigator
withdrawal, died/death,
completed) (see Diagram 7).
Regarding the regulatory de昀椀nition
of “enrolled”, the author refers
to ClinicalTrials.gov Protocol
Registration Data Element
De昀椀nitions for Interventional
and Observational Studies,
which states “’Enrolled’ means
a participant’s, or their legally
authorized representative’s,
agreement to participate in a
clinical study following completion
of the informed consent process.”
Therefore, consented equals
enrolled.
pathology or laboratory test results, physical exams, outside records). In other word
rely on “yes” and “no” check boxes with a general “blanket” statement such as, “T
not meet the inclusion or exclusion criteria outlined in the protocol.” You must hav
each item on the checklist. Diagram 6
As with the completion of the ICF, the staff member reviewing subjects for eligibility and completing this
checklist should be qualified, 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 confirmation of eligibility, as well as documentation of oversight.
A fully verified Eligibility Checklist with complete supporting source documentation can prevent queries
from monitors / auditors about whether a subject meets inclusion / exclusion criteria, and more
importantly, avoid major issues with the FDA and/or the Sponsor.
The Screening and Enrollment Log(s)
Documentation of Screening and Enrollment is recommended as best practice for all studies. Along with
offering a snapshot of current subjects, the Screening and/or Enrollment Logs also track information such
as reasons for screening failures, withdrawals, or terminations. This information is helpful in the
completion of IRB continuing review submissions, as well as the design of future studies.
GCP defines Screening Logs and Enrollment Logs separately, however, many clinical research sites
combine them into one document with specific codes or status to indicate the final placement of subjects
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(e.g., failed screening / screening failure, subject withdrawal / consent withdrawal, clinical investigator
withdrawal, died / death, completed) (see Diagram 7).
Diagram 7
As with all essential documents,
the Screening and/or Enrollment
Logs should be created prior to
study start-up and completed in
a timely manner.
Regarding the regulatory definition of “enrolled”, the author refers to ClinicalTrials.gov Protocol
Registration Data Element Definitions for Interventional and Observational Studies, which states
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