November 2024 SOCRA Source Journal - Journal - Page 41
more common and increase
ef昀椀ciency, they do not allow for
this handwriting comparison.
This has brought about the use
of individual signature pages (see
Diagram 3). In this situation, the
main DOA Log is electronic, with
each study member completing
an individual signature page in
hard copy, which is then 昀椀led in
a central location.
The clinical investigator must
con昀椀rm their approval and
oversight of delegation by
initialing or signing and dating
each entry on the DOA Log.
Depending on the log required
by the clinical research site/
Sponsor, the clinical investigator
may sign/initial and date each
entry either only at the beginning
of a staff member’s participation
or at both the beginning and
end of participation. Although
lapses of days, weeks, or
months in clinical investigator
initial/signature and date have
been noted, obtaining this
documentation prior to the staff
performing delegated duties is
best practice.
Overall clinical investigator
authorization is found at the
bottom of each log, where the
clinical investigator can sign prior
to consenting the 昀椀rst subject
or at the conclusion of the
study, based on the processes
of the clinical research site, the
Sponsor, and the log’s format.
If the clinical investigator changes
during the study, a new DOA Log
can be created or the original log
can be revised.
If a new log is created, the old
log should be 昀椀nalized and
retired by following these steps:
•
•
•
Add stop dates to active staff
Obtain former clinical
investigator’s initial and
date for all entries
Former clinical investigator
Diagram 3
The clinical investigator must confirm their approval and oversight of delega
should
theon the DOA Log.
See Table
1 (on next
page)
for
and
datingcomplete
each entry
Depending
on the
log required
by th
authorization
昀椀eld,
if
not
more
information
on
completion
Sponsor, the clinical investigator may sign / initial and date each entry either
already done
of the DOA Log.
staff
member’s participation or at both
the beginning and end of participation
• weeks,
Stop date
on oldinlog
and investigator initial / signature and date have bee
or months
clinical
Our assessment of the most
start date on new log
documentation
prior
to
the
staff
performing
duties
is best practice.
commondelegated
昀椀ndings on
review
should coincide with IRB
of DOA Logs by monitors /
con昀椀rmation of the clinical
auditors
Overall
clinicalchange
investigator authorization
is is:
found at the bottom of each log,
investigator
investigator can sign prior to consenting
the first
subject
or at the conclusion
• Study
tasks
have been
If processes
the currentofDOA
Log
is
kept:
carried
out
by
staff
the clinical research site, the Sponsor, and thenot
log’s format.
listed on the DOA Log
• Strikethrough clinical
name at the
• Staff
tasks
If investigator’s
the clinical investigator
changes during
thebeing
study,delegated
a new DOA
Log can be
top
of
each
page
and
add
without
the
appropriate
can be revised.
the new clinical investigator’s
education, training, and
level
experience
If name
a new log is created, the old log should
be of
finalized
and retired by followi
• New clinical investigator
• Staff responsibilities are
Addthe
stoplog
dates to active staff
should review
improperly documented
Obtain
former
initial
and昀椀le,
date
and sign/initial
and
date clinical investigator’s
• No DOA Log
is on
orfor all entrie
beside theFormer
previous
clinical investigatorlog
should
complete
the
authorization
fi
is 昀椀led but blank
clinical investigator’s
Stop date on old log and• start
log should coincide w
Logdate
hason
notnew
been
signature/initials to con昀椀rm
completed
in
a
timely
clinical investigator change
acknowledgement
manner as staff changes
• Create NTF to document the
• Responsibilities or tasks
If details
the current
Logincluding
is kept:
of theDOA
change,
are updated without an
Strikethrough
clinical investigator’s
name at the top of each pag
the IRB approval
date
audit trail
investigator’s name
New clinical investigator should review the log and sign / initial
clinicalSOCRA
investigator’s
signature
/ initials to
confirm acknowledg
SOURCE
© November
2024
41
Create NTF to document the details of the change, including the
