November 2024 SOCRA Source Journal - Journal - Page 39
• 4.8.11: “Prior to participation
in the trial, the subject or the
subject’s legally acceptable
representative should receive
a copy of the signed and
dated written informed
consent form and any other
written information provided
to the subjects.”
As always, study teams should
follow procedures outlined by
their site, sponsor and IRB, in
agreement with FDA regulations
and GCP guidelines, for
completing the consent form
and process.
Our assessment of the most
common 昀椀ndings on review of
ICF and consent process by
monitors / auditors is:
•
Fields are not 昀椀lled out/left
blank unintentionally
•
•
•
•
•
•
•
Subject and/or staff capture
information in the wrong
昀椀eld(s)
Dates are incorrect
Cross-outs or handwritten
corrections made on the
original ICF (some clinical
research sites/Sponsors
consider this an unacceptable
practice, recommending
Note-to-File [NTF] instead)
Consent process note does
not indicate that the subject
was provided with a copy of
the form
Consent is obtained using
an outdated version of ICF
Re-consent was not obtained
as required by Sponsor/IRB
Pages are missing, either
from the original document
or the scanned medical
record submission
The Delegation of Authority Log
Of all the essential forms, the
Delegation of Authority (DOA)
Log is one reviewed most
frequently during visits by both
monitors and auditors. Neither
FDA nor GCP require clinical
research sites to maintain a
DOA Log, per se. However,
both bodies con昀椀rm the need
to document the delegation of
signi昀椀cant trial-related duties (see
Diagram 2).
According to FDA Guidance
for Industry Investigator
Responsibilities — Protecting the
Rights, Safety, and Welfare of
Study Subjects: “The investigator
should maintain a list of the
appropriately quali昀椀ed persons
to whom signi昀椀cant trial-related
duties have been delegated.
This list should also describe
the delegated tasks, identify the
Diagram 2
According to FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety,
and Welfare of Study Subjects: “The investigator should maintain
list of the ©
appropriately
SOCRA aSOURCE
November qualified
2024
39
persons to whom significant trial-related duties have been delegated. This list should also describe the
delegated tasks, identify the training that individuals have received that qualifies them to perform
