November 2024 SOCRA Source Journal - Journal - Page 45
start-up and completed in a timely manner.
Case Report Forms
Case Report Forms
paper or electronic. Per GCP
health at baseline. Information
Case
Report
Forms
are
crucial
of(CRF):
clinical trial
documentation,
they are th
Case
Report
Forms
(CRFs)(CRFs)
are
1.11:
“Case elements
Report Form
documented
here can beas
later
crucial
elements
of
clinical
trial
A
printed,
optical,
or
electronic
linked
directly
to
conditions
of data entry, ultimately influencing the outcome of the study. While the study protocol outlin
documentation, as they are
document designed to record
noted on the Physical Exam
hypotheses
CRFs
therequired
final steps of data
the specif
the
last point of and
data objectives,
entry,
all of support
the protocol
Form,analysis,
indicatingcollecting
changes from
ultimately
in昀氀uencing
the
information
to
be
reported
baseline
leading
to
investigation
information needed in order to answer the questions proposed by the research. Therefore, the
outcome of the study. While the
to the sponsor on each trial
of possible Adverse Events (AEs)
design
of these
forms
should subject.”
be protocol-driven and all documents
must8).be approved by clini
study
protocol
outlines
speci昀椀c
(see Diagram
hypotheses
and objectives,
site and Sponsor
priorCRFs
to enrollment.
support the 昀椀nal steps of data
CRFs must meet all ALCOA+
Many forms serve as checklists,
analysis, collecting the speci昀椀c
standards (i.e., attributable,
acting as reminders to
CRFs areneeded
defined
clearly
guidelines
and may be either
paper
electronic. Per GCP 1
information
in order
to in GCP
legible,
contemporaneous,
ensure
that or
all procedures
answer
the
questions
proposed
original,
accurate
AND
are
completed
Report Form (CRF): A printed, optical, or electronic document designedper
toprotocol
record all of the
by the research. Therefore, the
complete, consistent, enduring,
and reported or documented
required
information
the sponsor
on each trial
subject.”
creation
and design
of theseto be reported
available,to
accessible,
credible,
appropriately.
For example,
forms should be protocol-driven
corroborated) in order to be
checking of “Yes” to a change
and all documents must be
veri昀椀able by monitors, auditors,
in concomitant medications
CRFs must
meetresearch
all ALCOA+
standards
(i.e., attributable, legible,
contemporaneous,
approved
by clinical
site
data
analysts, etc.
(Con Meds)
or signs/symptoms original
and
Sponsor
prior to enrollment.
could lead corroborated)
the coordinator in order to
AND
complete,
consistent, enduring, available, accessible, credible,
The Medical History Form is
to investigate whether the
verifiable by monitors, auditors,
data analysts, etc.
CRFs are de昀椀ned clearly in GCP
useful as a tool to capture
appropriate forms (Con Med or
guidelines and may be either
relevant conditions that establish
AE Logs) should be updated and
The Medical History Form is useful as a tool to capture relevant conditions that establish heal
baseline. Information documented here can be later linked directly to conditions noted on the
Exam Form, indicating changes fromDiagram
baseline 8
leading to investigation of possible Adverse Ev
(see Diagram 8).
Many forms serve as checklists, acting as reminders to ensure that all procedures are complet
protocol and reported or documented appropriately.
For example, checking of “Yes”45to a chan
SOCRA SOURCE © November 2024
concomitant medications (Con Meds) or signs / symptoms could lead the coordinator to inves
