February 2024 SOCRA Source Journal - Journal - Page 26
TABLE 1:
OVERVIEW OF CLINICALTRIALS.GOV
5.
A registry and results database of clinical studies involving
human participants
Developed in response to FDAAA requirements
Registry:
○ Launched February 29, 2000
○ 420,268 research studies posted (as of July 04, 2022)
Results database:
○ Launched September 2008
○ Results for 54,740 registered studies posted (as of July
04, 2022)
Legislation:
○ Section 801 of FDAAA: Required registration of clinical
studies meeting the definition of applicable clinical trial
○ Final Rule (42 CFR Part 11) 2017: Required responsible
parties to be in compliance starting April 18, 2017
responsible parties to be in
compliance starting April 18,
2017 and was effective as of
January 18, 2017.
ClinicalTrials.gov Protocol
Registration Data Element:
https://prsinfo.clinicaltrials.
gov/definitions.html
Registration information is
submitted to ClinicalTrials.gov
in 13 modules:
1. Study Identification: The
Study Identification module
contains identifiers and
titles that uniquely identify a
study within the sponsoring
organization.
2. Study Status: The Study
Status module contains
key dates and the Overall
Recruitment Status of a
study.
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3. Sponsor/Collaborators:
The Sponsor/Collaborators
module identifies who is
responsible for initiating,
funding, designing, and
conducting a study, as well
as who may be performing
data analysis and reporting.
4. Oversight: The Oversight
module includes information
related to the regulation
or supervision of certain
aspects of clinical research,
such as the regulatory
status of drug, biological,
and device products being
studied and protections for
human subjects. Studies
must have approval (or be
exempt, as appropriate)
from a Human Subjects
Protection Review Board
prior to the enrollment of
the first participant to be
SOCRA SOURCE © May 2023
6.
7.
8.
eligible for registration.
Study Description
Information: The Study
Description module
allows you to enter a short
description of the clinical
study (Brief Summary)
as well as an extended
description of the protocol
(Detailed Description). The
Brief Summary should be
written in language that will
be easily understood by the
general public. The Detailed
Description is optional and
can include more technical
information but should not
include the entire protocol
or repeat information found
in other data elements.
Conditions and Keywords:
The Conditions module
includes the Conditions and
Keywords list. Conditions
include the primary diseases
or conditions being studied
or the focus of the clinical
study. Keywords may
optionally be specified to
improve search results on
the ClinicalTrials.gov public
site.
Study Design: The
Interventional Study
Design module describes
the primary investigative
techniques used in the study
in which individuals are
assigned prospectively to an
intervention or interventions
according to a protocol
to evaluate the effect
of the intervention(s) on
biomedical or other health
related outcomes (i.e., a
clinical trial).
Arms, Groups, and
Interventions: The Arms
and Interventions module
outlines information about
the groups or subgroups
that participants will be