November 2024 SOCRA Source Journal - Journal - Page 40
training that individuals have
received that quali昀椀es them to
perform delegated tasks (e.g.,
can refer to an individual’s CV
on 昀椀le), and identify the dates
of involvement in the study. An
investigator should maintain
separate lists for each study
conducted by the investigator.”
This practice is reinforced in GCP
guidelines:
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4.1.5 Investigator’s Quali昀椀cations and Agreements: “The
investigator should maintain a
list of appropriately quali昀椀ed
persons to whom the investigator has delegated signi昀椀cant
trial-related duties.”
8.3.24 Essential Documents
for the Conduct of a Clinical
Trial – Signature Sheet: “To
document signatures and
initials of all persons authorized
to make entries and/or
corrections on CRFs.”
In theory, the DOA Log should
include all key staff members
who make a direct and signi昀椀cant
contribution to the clinical
data and/or perform any duty
or task that could signi昀椀cantly
impact subject safety, protocol
compliance, or data quality and
integrity. Ultimately, the clinical
research site and the Sponsor
will determine who should be
included. Most often, the log
includes the:
Regarding the primary pharmacist, this person is delegated by
the Investigator as the one ultimately responsible for the work
being performed by the staff
under their direct supervision.
Clinical research sites may 昀椀nd it
bene昀椀cial to create a pharmacyspeci昀椀c DOA Log along with a
NTF to document that the
primary clinical research pharmacist has delegated a portion of
their study-related duties to other
individuals selected by the
primary pharmacist.
Regarding the medical monitor,
the University of Arkansas for
Medical Sciences (UAMS) asks
that study teams include the
medical monitor along with
other key staff members. In
addition to simply proving that
the clinical investigator has
delegated a vitally important
task to a speci昀椀c person, if this
staff member ever had to weigh
in regarding a consent waiver,
Adverse Event/Serious Adverse
Event evaluation or any other
important trial-related decisions,
the signature on the log can be
used to validate the signature on
the report/documentation.
Responsibilities on the DOA Log
must be assigned accurately
and appropriately, with staff
delegated to roles based on their
training (e.g., perhaps physical
exams must be performed by
physicians or nurses).
The start date refers to the
date that the individual has
been delegated tasks by the
clinical investigator. As this date
marks the beginning of the
period during which the staff
member is directly involved with
conduct of the study, it must
precede the performance of
any study-speci昀椀c procedures.
Prior to delegation of the task,
all study training appropriate to
the role should be completed.
At UAMS, it is expected that
IRB acknowledgement should
also be received prior to staff’s
participation in study activities.
The stop date is when staff are
no longer delegated by the
clinical investigator to perform
the assigned tasks, whether that
be because they have taken on
a new role or responsibilities or
are leaving the institution.
Clinical Investigator
Sub-Investigators
Research nurses
Coordinators (both data
and regulatory)
Staff (e.g., nurses and technicians)
functioning in the scope of
routine practice and staff who are
not making a direct or signi昀椀cant
contribution to data should not
be added to the DOA Log. It
is necessary, however, to use
caution when allowing these
staff members to complete study
forms, as some Sponsors may
consider these “signi昀椀cant trialrelated duties”.
If a staff member’s role changes
or responsibilities are added or
removed, best practice would be
to add an end date to the current
entry corresponding to the date
the roles or responsibilities are
no longer being completed by
the individual. A new entry would
then be created corresponding
to the new role and/or
responsibilities. Rather than using
strikethrough, initial, date, this
method is easier to follow visually.
In the author’s experience,
the primary clinical research
pharmacist and the medical
monitor, key staff members
whose oversight could impact
signi昀椀cantly on subject safety,
protocol compliance or data
quality and integrity, should be
included on the main DOA log.
Depending on the site, different
ideas may exist about who
should be included on the DOA
Log, so it would be best to check
the site’s SOPs, speak to the
site’s managers, and consult the
Sponsor when determining the
appropriate staff to include on
the log.
Outside providing evidence of
clinical investigator delegation,
another function of the DOA
Log is to capture the signatures
and initials of the delegated
staff, allowing for veri昀椀cation of
study documentation attributed
to these individuals. While
electronic logs are becoming
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SOCRA SOURCE © November 2024
