February 2024 SOCRA Source Journal - Journal - Page 35
ACHIEVING AND
MAINTAINING COMPLIANCE
Teamwork is essential in
achieving and maintaining
compliance with the law and
the regulations related to
clinical trial registration and
results reporting. Data quality
is very important. Data posed
on ClinicalTrials.gov must be
consistent and specific. The
following examples illustrate
mistakes made in clinical
trial registration and results
reporting and the correct way to
provide information.
Example #1
Under Arms and Intervention,
the information under Placebo
Comparator stated:
“Participants received
Remuverol (study drug) or
placebo tablet matching
Remuverol orally twice daily for
24 weeks.”
The correct way to describe the
Placebo Comparator is:
“Participants received placebo
tablet matching Remuverol
orally twice daily for 24 weeks.”
Example #2
Under Secondary Outcome
Measures, the Change from
Baseline stated:
“Change from Baseline in
Clinical Chemistry Laboratory
Tests.”
ClinicalTrials.gov wants more
specific information on the
measurement of chemistry
levels, such as:
“Change from Baseline in
Sodium (m/Eq/L).”
Example #3
Participants Overall Assessment
of the Treatment stated:
“Effectiveness of the
intervention.”
The correct way to describe this
is:
“Number of participants who
rated effectiveness of treatment
as Good, Very Good, or
Excellent.
Each participant provided a
response to the question “How
effective do you think the study
medication is as a treatment for
pain?” Answers were rated on a
five-point scale:
1 = Poor,
2 = Fair,
3 = Good,
4 = Very Good, and
5 = Excellent.”
Example #4
Safety and Tolerability stated:
“Evaluate the safety and
tolerability of the intervention.”
The correct way to describe this
is:
“Number of participants with
adverse events as assessed by
CTCAE v4.0:
Common Terminology Criteria
for Adverse Events v4.0: uses a
range of grades from 1 to 5:
1 = Mild
2 = Moderate
3 = Severe
4 = Life-threatening
5 = Death.”
Example #5
The Secondary Outcome
Measures included all of the
measurements together:
“Change from baseline in Vital
Signs, Including Pulse Rate,
Systolic and Diastolic Blood
Pressures, Respiratory Rate,
and Oral Temperature. Change
in Pain using VAS. Change in
Health-Related Quality of Life
using SF-36 and EQ-5D-3L.
The effect of the study drug on
Vital Signs, Pain, and HealthRelated Quality of Life.
[Time frame: 1 week]
ClinicalTrials.gov wants each
secondary outcome measure
listed separately, such as:
“Change from baseline in Pulse
Rate.
This measure was assessed
in the morning while the
participant was resting calmly
in a chair by the physician by
placing two fingers on the
wrist and counting the number
of beats in 60 seconds. The
change from baseline in pulse
rate was calculated as the value
recorded at 1 week minus the
value recorded at baseline.
[Time frame: baseline and 1
week]”
Example #6
The Secondary Outcome
Measures was not specific about
the time frame:
“Length of Hospital Stay in Days
Length of stay will be defined
by the duration between the
time of first study treatment to
the time a discharge order is
placed.”
[Time frame: From admission to
discharge.]
Quality data require being
specific about details such as
the time frame:
[Time frame: From admission to
discharge, up to 90 days.]
Example #7
The Primary Outcome Measure
listed the time frame as:
“Number of Participants with
Serious Adverse Events (SAEs).
An SAE is any untoward
medical occurrence that at
any dose results in death,
are life threatening, requires
hospitalization or prolongation
of hospitalization or results in
disability/incapacity.
SOCRA SOURCE © May 2023
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