November 2024 SOCRA Source Journal - Journal - Page 46
whether the IRB should be
noti昀椀ed (see Diagram 9).
whether the appropriate forms (Con Med or AE Logs) should be updated and whether the IRB should be
notified
(seethe
Diagram
9).
whether
appropriate
forms (Con Med or AE Logs) should be updated and whether
Diagram
notified (see 9
Diagram 9).
As previously discussed, only
quali昀椀ed, delegated and trained
personnel should complete forms.
Table 2 provides an overview of
how to create and complete
these forms.
Our assessment of the most
common 昀椀ndings on review of
CRFs by monitors/auditors is:
•
•
•
•
•
Data recorded on CRFs do
not match source
Fields left incomplete/
questions unanswered
Extraneous writing outside
dedicated 昀椀elds
Data are recorded without
being signed/initialed
and/or dated
Forms completed by nondelegated staff members
Note-to-File and Phone Call
Summary Templates
Other forms useful in the
documentation of clinical research
are the Note-to-File (NTF) and
phone call summary templates.
NTF are not necessarily a CRF,
but they are a useful tool to
keep in the clinical research
site’s arsenal to clarify or add
information to document speci昀椀c
requirements or standards, or
to address complicated issues
or discrepancies (see Diagram
10 on next page). NTF can and
should be used in the context
of explaining errors, however,
overuse of NTF is a red 昀氀ag to
any monitor or auditor, possibly
leading them to dig deeper into
昀椀les, so use sparingly.
As previously discussed, only qualified, delegated and trained personnel should complete forms.
Table 2 provides an overview of how to create and complete these forms.
Our assessment of the most common findings on review of CRFs by monitors / auditors is:
• Data recorded on CRFs do not match source
As• previously
qualified,
delegated and trained personnel should compl
Fields left discussed,
incomplete / only
questions
unanswered
• Extraneous writing outside dedicated
fields
TABLE 2
• Data
are recorded
without being
signedto/ initialed
and/or
dated
Table
2 provides
an
overview
of how
create
and
complete
these forms.
How
to
Create
and
Complete
Case
Report
Forms
• Forms completed by non-delegated staff members
• assessment
When creating
forms:
Our
of the
most
common
findings on review of CRFs by monitors / auditor
Note-to-File
and Phone
Call
Summary
Templates
o
Ensure
consistent
formatting
(e.g.
date source
format, font, spacing)
• Data recorded on CRFs
do not
match
o De昀椀ne all units (e.g., Fahrenheit for temperature, pounds for weight)
Other •formsFields
useful left
in the
documentation
of
clinical
research
are the Note-to-File (NTF) and phone call
incomplete / questions unanswered
otemplates.
Include reminders to ensure that procedures follow the protocol and
summary
• Extraneous
writing
outside dedicated
fields
are reported
or documented
appropriately
• When
are recorded
without
signed
initialed
dated site’s arsenal to
completing
forms:
NTF• are
notData
necessarily
a CRF,
but
they arebeing
a useful
tool to/ keep
in the and/or
clinical research
•
Forms
completed
by
non-delegated
staff
members
subject to
IDs,
not protected
information
(PHI) (e.g.,
name, complicated
clarify oroaddUse
information
document
specific health
requirements
or standards,
or to address
issues or discrepancies
(see Diagram 10). NTF can and should be used in the context of explaining errors,
date of birth)
however,
of NTF
is a red
flagcircles
to any monitor
or auditor, possibly leading them to dig deeper into
Note-to-File
Phone
Call
Summary
Templates
ooveruse
Useand
checkboxes,
not
files, so use sparingly.
o Include dedicated 昀椀elds for signature or initial of person completing
Other forms
theuseful
form in the documentation of clinical research are the Note-to-File (NTF
- For a form to serve as its own source, it should be signed and
summary templates.
dated by the person completing it, even if that is the subject
o not
Include
version a
number/date
in the
NTF are
necessarily
CRF, but they
arefooter
a useful tool to keep in the clinical researc
clarifyoor add
information
to
document
specific
requirements or standards, or to addres
Follow CRF completion guidelines, if applicable
issues oor discrepancies
(see Diagram
10). with
NTFsource
can and
Ensure data entries
are consistent
datashould be used in the context o
however,
ofinNTF
is a manner
red flag to any
monitor
or auditor, possibly leading them
o overuse
Complete
a timely
12
files, so
use
sparingly.
o Write legibly
o
Avoid abbreviations and acronyms
o
Complete all 昀椀elds, unless otherwise indicated; strike through empty
昀椀elds
o
Our best practice recommendations for use of NTF:
Enter reason for missed data (e.g., not done, unknown, not
applicable)
o
Do not write outside designated boxes; if necessary, write comments
separately in NTF
Print on letterhead
Generate on a case-by-case
basis
o
Use Good Documentation Practice (GDocP) to correct errors
•
•
46
o
12 and trained personnel
Form must be completed by quali昀椀ed, delegated
SOCRA SOURCE © November 2024
