February 2024 SOCRA Source Journal - Journal - Page 27
assigned to in a clinical trial,
as well as any interventions
assigned to each group in
the study protocol.
9. Outcome Measures: The
purpose of the Outcome
Measures module is to
include information about
the primary, secondary, and
other pre-specified outcome
measures that will be
collected and analyzed for a
study. An outcome measure
is an assessment that is
used to determine the
effect of an experimental
variable (for example, an
intervention) on participants
in the study. Outcome
Measures should clearly
and accurately describe
what will be measured and
reported and not the goal or
objective of an assessment
or of the study itself (or
for observational studies,
specific key measurement[s]
or observation[s] used
to describe patterns
of diseases or traits or
associations with exposures,
risk factors or treatment.
For each Outcome
Measure, the Measure Type,
Measure Title, Measure
Description and Time Frame
data elements fields are
provided. Summary level
results may be included
after the study is completed
and the Outcome Measure
information (measure title,
measure description and
time frame) will provide
information for general
readers to understand the
reported data.
10. Eligibility: The Eligibility
module specifies sex/
gender, age, and a limited
list of the criteria for
determining who is eligible
to participate in the study.
11. Contacts, Locations, and
Investigator Information:
The Contacts/Locations
module specifies contacts
and study officials for the
overall study. For each study
site the module includes
the name and location
of the facility, along with
facility contacts and site
investigators. This module
consists of two screens: Edit
Overall Contacts and Edit
Location. Information for the
central contact person or
facility contact is required to
register a study.
12. IPD (Individual Participant
Data) Sharing Statement:
The IPD Sharing Statement
is an optional module
in ClinicalTrials.gov but
required by the International
Committee of Medical
Journal Editors (ICMJE). This
module collects information
on how Individual
Participant Data (IPD) and
other supporting materials
will be made available to
other researchers.
13. References Information:
The References module
collects information
about references to
other information about
the study. This includes
citations for journal articles
and publications, links to
websites related to the
study, and links to available
individual participant data
(IPD) sets and supporting
information.
ClinicalTrials.gov Results Data
Element: https://prsinfo.
clinicaltrials.gov/results_
definitions.html
The study results must be
summarized in a tabular format,
per arm or group, in four
scientific modules and two
administrative modules.
1. Participant Flow: A
participant flow shows how
participants were assigned
to the arms or groups of
a clinical study and how
they progressed through
the stages of the study.
Participant flow information
is typically depicted as a
CONSORT flow diagram
in journal publications
(see Schulz KF, Altman
TABLE 2:
CLINICAL TRIAL REGISTRATION AND RESULTS REPORTING
ON CLINICALTRIALS.GOV
Who registers trials and submits results:
• The responsible party
Within 21 days after enrollment of the first participant:
• Register the clinical trial
At least every 12 months:
• Update the registration
Within 1 year of the trial’s primary completion date:
• Submit summary results (including adverse events) for certain
ACTs
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