Results Information Data Element Definitions (Reference Document)

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ClinicalTrials.gov Results Data Element Definitions
for Interventional and Observational Studies (DRAFT)
January 18, 2017

This document describes the definitions for results data elements submitted to ClinicalTrials.gov
for interventional studies (clinical trials) and observational studies. These definitions are mostly
adapted from 42 CFR Part 11.
Data element entries are annotated with symbols to indicate generally what information is
required to be submitted and under which circumstances. The responsible party must ensure that
the information provided complies with any applicable laws, regulations, or policies. For more
information about various requirements and definitions of regulatory terms under 42 CFR Part
11, see Support Materials.
Note: The term "clinical study" is used to refer to both interventional and observational studies.
The term "participant" is used to refer to a human subject.

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Required

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Conditionally required

Required if Primary Completion Date is on or after January 18, 2017

1. Participant Flow
Information to document the progress of research participants through each stage of a study in a
tabular format, including the number of participants who started and completed the clinical
study. (Identical in purpose to a CONSORT flow diagram, but represented as tables).
The tabular presentation may be separated into "periods," each of which comprises an interval of
study activity. Each period consists of "milestones" for reporting numbers of participants at
particular points in time within that period.
Recruitment Details
Definition: Key information relevant to the recruitment process for the overall study,
such as dates of the recruitment period and types of location (For example, medical
clinic), to provide context.
Limit: 350 characters.

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Pre-assignment Details [*]
Definition: Description of significant events in the study (for example, wash out, run-in)
that occur after participant enrollment, but prior to assignment of participants to an arm
or group, if any. For example, an explanation of why enrolled participants were excluded
from the study before assignment to arms or groups.
Limit: 350 characters.

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Arm/Group Information
Definition: Arms or groups for describing the flow of participants through the clinical
study. In general, it must include each arm to which participants were assigned.

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Arm/Group Title
Definition: Descriptive label used to identify each arm or group.
Limit: >=4 and <= 62 characters.

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Arm/Group Description §
Definition: Brief description of each arm or group. In general, it must include
sufficient details to understand each arm to which participants were assigned and
the intervention strategy used in each arm.
Limit: 999 characters.
Type of Units Assigned [*]
Definition: If assignment is based on a unit other than participants, a description of the
unit of assignment (for example, eyes, lesions, implants).
Limit: 40 characters.

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Period(s)
Definition: Discrete stages of a clinical study during which numbers of participants at
specific significant events or points of time are reported.
There is no limit to the number of periods that may be used to describe a single study.
Each subsequent period represents a study stage following the previous period. That is,
participants "flow" from earlier to later periods.

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Period Title
Definition: Title describing a stage of the study. If only one period is defined, the default
title is Overall Study. When a study has more than one period, none of the Period Titles
should be Overall Study.
Limit: 40 characters.

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Started
Definition: Number of participants initiating the period. In the first period, it is the
number of participants assigned to each arm or group. If assignment is based on a
unit other than participants, also include the number of units at the beginning of
the period.
Comments
Definition: Additional information about the Started milestone or
Milestone Data.
Limit: 100 characters.

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Completed
Definition: Number of participants at the end of the period. If assignment is based
on a unit other than participants, also include the number of units at the end of the
period.
Comments
Definition: Additional information about the Completed milestone or
Milestone Data.
Limit: 100 characters.
Not Completed (calculated automatically)
Definition: Number of participants (and units, if applicable) that did not complete
the study or period. This is calculated automatically by subtracting Completed
from Started.
Additional Milestone(s)
Definition: Any specific events or time points in the study when the numbers of
participants (and units, if applicable) are reported. While there is no limit to the
number of milestones that may be used in a single period, data are required for
two milestones, Started and Completed, within each period.
Milestone Title [*]
Definition: : Label describing the milestone
Limit: 40 characters.
Milestone Data [*]
Definition: Number of participants to reach the milestone, in each
arm/group. If assignment is based on a unit other than participants, also
include the number of units to reach the milestone.
Comments: Additional information about the milestone or data.
Limit: 100 characters.

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Reason Not Completed
Definition: Additional information about participants who did not complete the
study or period. If reasons are provided, the total number of participants listed as
Not Completed must be accounted for by all reasons for non-completion.
Reason Not Completed Type [*]
Definition: Reason why participants did not complete the study or period.
Select one.
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Adverse Event
Death
Lack of Efficacy
Lost to Follow-Up
Physician Decision
Pregnancy
Protocol Violation
Withdrawal by Subject
Other

Other Reason [*]
Definition: A brief description of the reason for non-completion, if "Other"
Reason Not Completed Type is selected.
Limit: 40 characters.
Reason Not Completed Data [*]
Definition: Number of participants in each arm or group that did not complete
the study or period, for each Reason Not Completed.

2. Baseline Characteristics
A table of demographic and baseline measures and data collected by arm or comparison group
and for the entire population of participants in the clinical study.

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Arm/Group Information
Definition: Arms or comparison groups in the study, including all participants assessed at
baseline as specified in the pre-specified protocol and/or statistical analysis plan.

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Arm/Group Title
Definition: Descriptive label used to identify each arm or comparison group.
Limit: >= 4 and <= 62 characters.

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Arm/Group Description §
Definition: Brief description of each arm or comparison group. In general, it must
include sufficient detail to understand how the arm(s) or comparison groups were
derived from the arm(s) to which participants were assigned in Participant Flow
(if different) and the intervention strategy in each arm/group.
Limit: 999 characters.
Baseline Analysis Population Information

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Overall Number of Baseline Participants
Definition: Total number of participants for whom baseline characteristics were
measured, in each arm/group and overall.
Overall Number of Units Analyzed [*]
Definition: If the analysis is based on a unit other than participants, the number of
units for which baseline measures were measured and analyzed, in each
arm/group and overall.
Type of Units Analyzed [*]
Definition: If the analysis is based on a unit other than participants, a description
of the unit of analysis (for example, eyes, lesions, implants).
Limit: 40 characters.
Baseline Analysis Population Description [*]
Definition: If the Overall Number of Baseline Participants (or units) differs from
the number of participants (or units) assigned to the arm or comparison group and
overall, a brief description of the reason(s) for the difference such as how the
analysis population was determined.
Limit: 350 characters.

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Baseline Measure Information
Definition: A description of each baseline or demographic characteristic measured in the
clinical study. Required baseline measures include Age, Sex/Gender, Race, Ethnicity (if
collected under the protocol), and any other measure(s) that were assessed at baseline and
used in the analysis of the primary outcome measure(s).

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Baseline Measure Title
Definition: The name of the baseline or demographic characteristic measured in the
clinical study. Select as many as needed.

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Study-Specific Measure

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Age
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*§ (Select as many as needed)

* (Select at least one of the following):
Age, Continuous: For example - mean or median age
Age, Categorical:
• <=18 years
• >18 and <65 years
• >=65 years
Age, Customized: Customizable age categories

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Sex/Gender (Select at least one of the following):
• Sex: Female, Male
• Sex/Gender, Customized

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Race and Ethnicity §
• Race (NIH/OMB): U.S. National Institutes of Health and U.S. Office of
Management and Budget Classification Categories
• Ethnicity (NIH/OMB): U.S. National Institutes of Health and U.S. Office of
Management and Budget Classification Categories
• Race/Ethnicity, Customized
• Race and Ethnicity Not Collected
Region of Enrollment

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Study-Specific Baseline Measure Title(s) [*]
Definition: If "Study-Specific Measure" is chosen, provide the name of the measure.
Limit: 100 characters.
Baseline Measure Description:
Definition: Additional descriptive information about the baseline measure, such as a
description of the metric used to characterize the specific baseline measure.
Limit: 600 characters.

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Measure Type
Definition: The type of data for the baseline measure. Select one.
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Count of Participants
Mean
Median
Least Squares Mean
Geometric Mean
Geometric Least Squares Mean
Number
Count of Units

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Measure of Dispersion
Select one.
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Not Applicable (only if Measure Type is "Number", "Count of Participants", or
"Count of Units")
Standard Deviation
Inter-Quartile Range
Full Range

Number of Baseline Participants [*]
Definition: The number of participants analyzed for the baseline measure, if different
from the Overall Number of Baseline Participants, in each arm/group and overall.
Number of Units Analyzed [*]
Definition: The number of units analyzed for the baseline measure, if different from the
Overall Number of Units Analyzed, in each arm/group and overall.
Analysis Population Type [*]
Definition: Indicate whether the baseline measure analysis is based on participants or
units other than participants. Only applies if Type of Units Analyzed is specified. Select
Participants/Other Units.
Measure Analysis Population Description [*]
Definition: Explanation of how the number of participants (or units) for analysis was
determined, if different from the Overall Number of Participants [or Units] Analyzed.
Limit: 350 characters.
Category or Row Title [*]
Definition: Name of distinct category or row for a baseline measure, if any. Category
Titles are only for mutually exclusive and exhaustive categories summarizing data using
the Measure Type of a "Count of Participants" or "Count of Units." Row Titles are for
any type of data.
Limit: 50 characters.

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Baseline Measure Data
Definition: The value(s) for each baseline measure, for each arm/group and overall.
NA (Not Available) Explanation [*]
Definition: Explain why baseline measure data are not available, if "NA" is
reported for Baseline Measure Data.
Limit: 250 characters.
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Unit of Measure
Definition: An explanation of what is quantified by the data (for example, participants,
mm Hg), for each baseline measure.
Limit: 40 characters.

3. Outcome Measures
A table of data for each primary and secondary outcome measure by arm (that is, initial
assignment of participants to arms or groups) or comparison group (that is, analysis groups),
including the result(s) of scientifically appropriate statistical analyses that were performed on the
outcome measure data, if any.
Note: Outcome measure information from the Protocol Section of the record will be copied into
the Results Section the first time results are created.

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Outcome Measure Information
Definition: A description of each outcome measure.
Note: "Outcome measure" means a pre-specified measurement that is used to determine
the effect of an experimental variable on participants in the study. Post-hoc (that is, not
pre-specified) outcome measures may also be reported.

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Outcome Measure Type
Definition: The type of outcome measure. Select one.
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Primary
Secondary
Other Pre-specified
Post-Hoc

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Outcome Measure Title
Definition: Name of the specific outcome measure.
Limit: 255 characters.

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Outcome Measure Description §
Definition: Additional information about the outcome measure, including a description of
the metric used to characterize the specific outcome measure.
Limit: 999 characters.

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Outcome Measure Time Frame
Definition: Time point(s) at which the measurement was assessed for the specific metric
used. The description of the time point(s) of assessment must be specific to the outcome
measure and is generally the specific duration of time over which each participant is
assessed (not the overall duration of the study).
Limit: 255 characters.
Anticipated Reporting Date:
Definition: If Outcome Measure Data are not included for an outcome measure, provide
the expected month and year they will be submitted.

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Arm/Group Information
Definition: Arms or comparison groups in the study, including all arms or comparison
groups based on the pre-specified protocol and/or statistical analysis plan.

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Arm/Group Title
Definition: Descriptive label used to identify each arm or comparison group.
Limit: >= 4 and <= 62 characters.

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Arm/Group Description: §
Definition: Brief description of each arm or comparison group. In general, it must
include sufficient detail to understand how the arm(s) or comparison groups were
derived from the arm(s) to which participants were assigned in Participant Flow
(if different) and the intervention strategy in each arm/group.
Limit: 999 characters.
Analysis Population Information

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Overall Number of Participants Analyzed
Definition: Number of participants for whom an outcome measure was measured
and analyzed, for each outcome measure and each arm/group.
Type of Units Analyzed [*]
Definition: If the analysis is based on a unit other than participants, a description
of the unit of analysis (for example, eyes, lesions, implants).
Limit: 40 characters.
Overall Number of Units Analyzed [*]
Definition: If the analysis is based on a unit other than participants, the number of
units for which an outcome was measured and analyzed, for each outcome
measure and each arm/group.

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Analysis Population Description [*]
Definition: If the Number of Participants Analyzed or Number of Units Analyzed
differs from the number of participants or units assigned to the arm or comparison
group, a brief description of the reason for the difference (such as how the
analysis population was determined).
Limit: 350 characters.
Outcome Measure Data Table

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Measure Type
Definition: The type of data for the outcome measure. Select one.
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Count of Participants
Mean
Median
Least Squares Mean
Geometric Mean
Geometric Least Squares Mean
Number
Count of Units

Measure of Dispersion/Precision
Select one.
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Not Applicable (only if Measure Type is "Number," "Count of Participants," or
"Count of Units")
Standard Deviation
Standard Error
Inter-Quartile Range
Full Range
80% Confidence Interval
90% Confidence Interval
95% Confidence Interval
97.5% Confidence Interval
99% Confidence Interval
Other Confidence Interval Level
Geometric Coefficient of Variation (only when Measure Type is "Geometric
Mean")

Other Confidence Interval Level [*]
Definition: The numerical value for the confidence interval level, if "Other
Confidence Interval Level" is selected. Provide a rationale for choosing this level in
the Outcome Measure Description.
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Category or Row Title [*]
Definition: Name of distinct category or row for an outcome measure, if any. Category
Titles are only for mutually exclusive and exhaustive categories summarizing data using
the Measure Type of a "Count of Participants" or "Count of Units". Row Titles are for
any type of data.
Limit: 50 characters.
Number of Participants Analyzed [*]
Definition: The number of participants analyzed for the outcome measure in the
row and for each arm/group, if different from the overall Number of Participants
Analyzed.
Limit: 50 characters.
Number of Units Analyzed [*]
Definition: The number of units analyzed for the outcome measure in the row and
for each arm/group, if different from the overall Number of Units Analyzed.

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Outcome Data
Definition: The measurement value(s) for each outcome measure, including each
category/row and each arm/group.
NA (Not Available) Explanation [*]
Definition: Explain why outcome measure data are not available, if "NA" is
reported for Outcome Data.
Limit: 250 characters.

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Unit of Measure
Definition: An explanation of what is quantified by the data (for example, participants,
mm Hg), for each outcome measure.
Limit: 40 characters.

Statistical Analyses [*]
Definition: Result(s) of scientifically appropriate tests of statistical significance of the
primary and secondary outcome measures, if any. Such analyses include: pre-specified in
the protocol and/or statistical analysis plan; made public by the sponsor or responsible
party; conducted on a primary outcome measure in response to a request made by FDA.
If a statistical analysis is reported "Comparison Group Selection" and "Type of Statistical
Test" are required. In addition, one of the following data elements are required with the

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associated information: "P-Value," "Estimation Parameter," or "Other Statistical
Analysis."
Statistical Analysis Overview:
Definition: Summary description of the analysis performed.
Comparison Group Selection [*]
Definition: The arms or comparison groups involved in the statistical analysis (check all
to indicate an "omnibus" analysis).
Comments:
Definition: Additional details about the statistical analysis, such as null hypothesis
and description of power calculation.
Limit: 500 characters.
Type of Statistical Test [*]
Definition: Identifies the type of analysis. Select one.
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Superiority
Non-inferiority
Equivalence
Other (for example, single group or other descriptive analysis)
Non-Inferiority or Equivalence (legacy selection)
Superiority or Other (legacy selection)
Comments: [*]
Definition: If, "Non-inferiority" or "Equivalence," provide additional details,
including details of the power calculation (if not previously provided), definition
of non-inferiority or equivalence margin, and other key parameters.
Limit: 500 characters.

Statistical Test of Hypothesis (or Method of Estimation or Other Statistical Analysis
required)
Definition: Procedure used for statistical analysis of outcome data and the calculated pvalue.
P-Value [*]
Definition: Calculated p-value given the null-hypothesis
Comments: Additional information, such as whether the p-value is adjusted for
multiple comparisons and the a priori threshold for statistical significance
Limit: 250 characters.

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Method [*]
Definition: The statistical test used to calculate the p-value, if a P-Value is reported.
Select one.
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ANCOVA
ANOVA
Chi-Squared
Chi-Squared, Corrected
Cochran-Mantel-Haenszel
Fisher Exact
Kruskal-Wallis
Log Rank
Mantel Haenszel
McNemar
Mixed Models Analysis
Regression, Cox
Regression, Linear
Regression, Logistic
Sign Test
t-Test, 1-Sided
t-Test, 2-Sided
Wilcoxon (Mann-Whitney)
Other

Other Method Name [*]
Definition: If "Other" is selected, provide name of statistical test.
Limit: 40 characters.
Comments:
Definition: Any other relevant information about the statistical test, such as adjustments
or degrees of freedom.
Limit: 150 characters.
Method of Estimation (or Statistical Test of Hypothesis or Other Statistical Analysis
required)
Definition: Procedure used to estimate effect of intervention.
Estimation Parameter [*]
Select one.
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Cox Proportional Hazard
Hazard Ratio (HR)
Hazard Ratio, Log
Mean Difference (Final Values)
Mean Difference (Net)

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Median Difference (Final Values)
Median Difference (Net)
Odds Ratio (OR)
Odds Ratio, Log
Risk Difference (RD)
Risk Ratio (RR)
Risk Ratio, Log
Slope
Other

Other Parameter Name [*]
Definition: The name of the estimation parameter, if “Other” Estimation Parameter is
selected.
Limit: 40 characters.
Estimated Value [*]
Definition: The calculated value for the estimation parameter.
Confidence Interval (If applicable)
Level [*]
Expressed as a percentage.
Number of Sides [*]
Select 1-sided or 2-sided.
Lower Limit [*]
Definition: Required if confidence interval is "2-sided" or if confidence interval is "1sided" and no Upper Limit is entered.
Upper Limit [*]
Definition: Required if confidence interval is "2-sided" or if confidence interval is "1sided" and no Lower Limit is entered.
NA (Not Available) Explanation [*]
Definition: Explain why the upper limit data are not available, if "NA" is reported as
upper-limit of "2-sided" confidence interval.
Limit: 250 characters.
Parameter Dispersion Type
Select one.
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Standard Deviation

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Standard Error of the Mean

Dispersion Value
Definition: The calculated value for the dispersion of the estimated parameter.
Estimation Comments
Definition: Any other relevant estimation information, including the direction of the
comparison (for example, describe which arm or comparison group represents the
numerator and denominator for relative risk).
Limit: 250 characters.
Other Statistical Analysis
Definition: If the statistical analysis cannot be submitted using the Statistical Test of
Hypothesis or Method of Estimation options, provide a description and the results of any
other scientifically appropriate tests of statistical significance.

4. Adverse Event Information
Information for completing three tables summarizing adverse events.

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1. All-Cause Mortality: § A table of anticipated and unanticipated events (not included in
the serious adverse event table) that exceed a frequency threshold (for example, 5 %)
within any arm of the clinical study, grouped by organ system, with number and
frequency of such events in each arm/group of the clinical study.

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2. Serious Adverse Events:
A table of all anticipated and unanticipated serious adverse
events, grouped by organ system, with number and frequency of such events in each
arm/group of the clinical study. (See Adverse Events definition below).

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3. Other (Not Including Serious) Adverse Events:
A table of anticipated and
unanticipated events (not included in the serious adverse event table) that exceed a
frequency threshold (for example, 5 %) within any arm of the clinical study, grouped by
organ system, with number and frequency of such events in each arm/group of the
clinical study.

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Time Frame §
Definition: The specific period of time over which adverse event data were collected.
Limit: 500 characters.
Adverse Event Reporting Description [*]
Definition: If the adverse event information collected in the clinical study is collected based
on a different definition of adverse event and/or serious adverse event than the Adverse
Events definition below, a brief description of how the definitions differ. May also be used to

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provide any additional relevant information about adverse event collection, including details
about the method of systematic assessment (for example, daily questionnaire) or information
about how the analysis population was determined (if the Number of Participants at Risk
differs from the number of participants assigned to the arm or comparison group).
Limit: 500 characters.
Source Vocabulary Name for Table Default
Definition: Standard terminology, controlled vocabulary, or classification and version from
which adverse event terms are drawn, if any (for example, SNOMED CT, MedDRA 10.0).
Default value for Source Vocabulary Name to be applied to all adverse event terms entered
in the "Serious Adverse Event" and "Other (Not Including Serious) Adverse Event" tables. If
necessary, Source Vocabulary Name may also be specified for specific Adverse Event
Terms.
Limit: 20 characters.

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Collection Approach for Table Default § (or Collection Approach for each Adverse
Event Term required)
Definition: The type of approach taken to collect adverse event information. Default value
for the type of approach taken to collect adverse event information (Systematic or NonSystematic Assessment) to be applied to all adverse event terms entered in the "Serious
Adverse Event" or "Other (Not Including Serious) Adverse Event" tables. If necessary,
Collection Approach may also be specified for specific Adverse Event Terms. Select one.
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Systematic Assessment: Any method of routinely determining whether or not certain
adverse events have occurred, for example through a standard questionnaire, regular
investigator assessment, regular laboratory testing, or other method
Non-Systematic Assessment: Any non-systematic method for determining whether or
not adverse events have occurred, such as self-reporting by participants or occasional
assessment/testing

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Arm/Group Information
Definition: Arms or comparison groups in the study, including all arms or comparison groups
based on the pre-specified protocol and/or statistical analysis plan.

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Arm/Group Title
Definition: Label used to identify each arm or comparison group.
Limit: >=4 and <= 62 characters.

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Arm/Group Description §
Definition: Brief description of each arm or comparison group. In general, it must include
sufficient detail to understand how the arm(s) or comparison groups were derived from
the arm(s) to which participants were assigned in Participant Flow and the intervention
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strategy in each arm/group.
Limit: 999 characters.
Adverse Events
Definition: Any untoward or unfavorable medical occurrence in a participant, including any
abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or
disease, temporally associated with the participant’s participation in the research, whether or
not considered related to the participant’s participation in the research.
Three types of adverse event data are to be reported: "All-cause Mortality," "Serious," and
"Other (Not Including Serious)" Adverse Events.
1. All-cause Mortality: The occurrence of death due to any cause.
2. Serious Adverse Events: Include adverse events that result in any of the following
outcomes: death, a life-threatening adverse event, inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant incapacity or
substantial disruption of the ability to conduct normal functions, or a congenital
anomaly/birth defect. Important medical events that may not result in death, be lifethreatening, or require hospitalization may be considered serious when, based upon
appropriate medical judgment, they may jeopardize the participant and may require
medical or surgical intervention to prevent one of the outcomes listed in this
definition.
3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious
Adverse Events.

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Total Number Affected by All-Cause Mortality
Definition: Overall number of participants, in each arm/group, who died due to any cause.

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Total Number at Risk for All-Cause Mortality
Definition: Overall number of participants, in each arm/group, included in the assessment of
deaths due to any cause (that is, the denominator for calculating frequency of all-cause
mortality).

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Total Number Affected by Any Serious Adverse Event
Definition: Overall number of participants affected by one or more Serious Adverse Events,
for each arm/group.

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Total Number at Risk for Serious Adverse Events
(or Number at Risk for each Serious
Adverse Event Term required)
Definition: Overall number of participants included in the assessment of serious adverse
events (that is, the denominator for calculating frequency of serious adverse events), for each
arm/group.

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Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events
Definition: Specify the frequency of occurrence that an Other (Not Including Serious)
Adverse Event must exceed, within any arm or comparison group, to be reported in the Other
(Not Including Serious) Adverse Event table. The number for the frequency threshold must
be less than or equal to the allowed maximum (5%). Do not include symbols (for example, >
or %) in the data field, it will be expressed as a percentage.
For example, a threshold of 5 percent indicates that all Other (Not Including Serious)
Adverse Events with a frequency greater than 5 percent within at least one arm or
comparison group are reported.
Total Number Affected by Any Other (Not Including Serious) Adverse Event Above the

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Frequency Threshold
Definition: Overall number of participants affected, for each arm/group, by at least one Other
(Not Including Serious) Adverse Event(s) reported in the table. Adverse events reported in
the table are those that occurred at a frequency exceeding the specified Frequency Threshold
(for example, 5%) within at least one arm or comparison group.

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(or Number
Total Number at Risk for Other (Not Including Serious) Adverse Events
at Risk for each Other, [Not Including Serious], Adverse Event Term required)
Definition: Overall number of participants, for each arm/group, included in the assessment of
Other (Not Including Serious) Adverse Events during the study (that is, the denominator for
calculating frequency of Other (Not Including Serious) Adverse Events).

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Adverse Event Term
Definition: Descriptive word or phrase for the adverse event.
Limit: 100 characters.

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Organ System
Definition: High-level categories used to group adverse event terms by body or organ system.
Select one. (Adverse events that affect multiple systems should be classified as "General
disorders.")
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Blood and Lymphatic System Disorders
Cardiac Disorders
Congenital, Familial and Genetic Disorders
Ear and Labyrinth Disorders
Endocrine Disorders
Eye Disorders
Gastrointestinal Disorders
General Disorders
Hepatobiliary Disorders
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Immune System Disorders
Infections and Infestations
Injury, Poisoning and Procedural Complications
Investigations
Metabolism and Nutrition Disorders
Musculoskeletal and Connective Tissue Disorders
Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps)
Nervous System Disorders
Pregnancy, Puerperium and Perinatal Conditions
Product Issues
Psychiatric Disorders
Renal and Urinary Disorders
Reproductive System and Breast Disorders
Respiratory, Thoracic and Mediastinal Disorders
Skin and Subcutaneous Tissue Disorders
Social Circumstances
Surgical and Medical Procedures
Vascular Disorders

Adverse Event Term Additional Description
Definition: Additional relevant information about the adverse event.
Limit: 250 characters.
Source Vocabulary Name
Definition: Standard terminology, controlled vocabulary, or classification and version from
which adverse event terms are drawn, if any (for example, SNOMED CT, MedDRA 10.0).
Leave blank to indicate that the value specified as the Source Vocabulary for Table Default
should be used.
Limit: 20 characters.

*

Collection Approach § (or Collection Approach for Table Default required)
Definition: The type of approach taken to collect adverse event information. Select one or
leave blank to indicate that the value specified as the Assessment Type for Table Default
should be used.
•

•

Systematic Assessment: Any method of routinely determining whether or not certain
adverse events have occurred, for example through a standard questionnaire, regular
investigator assessment, regular laboratory testing, or other method
Non-Systematic Assessment: Any non-systematic method for determining whether or
not adverse events have occurred, such as self-reporting by participants or occasional
assessment/testing

Adverse Event Data

*
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*

Number of Participants Affected
Definition: Number of participants, in each arm/group, experiencing at least one event
being reported.

*

Number of Participants at Risk
Definition: Number of participants assessed, in each arm/group, for adverse events (that
is, the denominator for calculating frequency of adverse events). Leave blank to indicate
that the value specified as the total at risk in the arm/group for the table should be used.
Number of Events
Definition: Number of occurrences, in each arm/group, of the adverse event being
reported.

5. Limitations and Caveats
Overall Limitations and Caveats
Definition: Describe significant limitations of the study. Such limitations may include not
reaching the target number of participants needed to achieve target power and statistically
reliable results or technical problems with measurements leading to unreliable or
uninterpretable data.
Limit: 250 characters.

6. Certain Agreements
Information indicating whether there exists an agreement between the sponsor or its agent and
the principal investigators (unless the sponsor is an employer of the principal investigators) that
restricts in any manner the ability of the principal investigators (PIs), after the completion of the
study, to discuss the results of the study at a scientific meeting or any other public or private
forum, or to publish in a scientific or academic journal information concerning the results of the
study. This does not include an agreement solely to comply with applicable provisions of law
protecting the privacy of participants.

*

Are all PIs Employees of Sponsor?
Definition: Indicate whether the principal investigator is an employee of the sponsor. Select
one.
•
•

Yes: The principal investigator is an employee of the sponsor
No: The principal investigator is not an employee of the sponsor

If "No" the following information is required:

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Results Disclosure Restriction on PI(s)? [*]
Definition: Indicate whether there exists any agreement (other than an agreement solely to
comply with applicable provisions of law protecting the privacy of participants participating
in the clinical study) between the sponsor or its agent and the principal investigator (PI) that
restricts in any manner the ability of the PI to discuss the results of the clinical study at a
scientific meeting or any other public or private forum or to publish in a scientific or
academic journal the results of the clinical study, after the Primary Completion Date. Select
Yes/No.
If there are agreements with multiple PIs who are not employees of the sponsor and there is a
disclosure restriction on at least one PI, select "Yes."
PI Disclosure Restriction Type
Definition: Additional information about the results disclosure restriction. If there are varying
agreements, choose the type below that represents the most restrictive of the agreements (for
example, the agreement with the greatest embargo time period). Select one.
•

•

•

The only disclosure restriction on the PI is that the sponsor can review results
communications prior to public release and can embargo communications regarding
study results for a period that is less than or equal to 60 days from the date that the
communication is submitted to the sponsor for review. The sponsor cannot require
changes to the communication and cannot unilaterally extend the embargo.
The only disclosure restriction on the PI is that the sponsor can review results
communications prior to public release and can embargo communications regarding
study results for a period that is more than 60 days but less than or equal to 180 days
from the date that the communication is submitted to the sponsor for review. The
sponsor cannot require changes to the communication and cannot unilaterally extend
the embargo.
Other disclosure agreement that restricts the right of the PI to disclose, discuss, or
publish study results after the study is completed

Other Disclosure Restriction Description
Definition: If "Other disclosure agreement..." is selected, describe the type of agreement
including any provisions allowing the sponsor to require changes, ban the communication, or
extend an embargo.
Limit: 500 characters.

7. Results Point of Contact
Point of contact for scientific information about the clinical study results information.

*

Name or Official Title
Definition: The person who is designated the point of contact. This may be a specific

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person's name (for example, Dr. Jane Smith) or a position title (for example, Director of
Clinical Trials).

*

Organization Name
Definition: Full name of the designated individual's organizational affiliation.

*

Phone: § Office phone number of the designated individual. Use the format 123-4567890 within the United States and Canada. If outside the United States and Canada,
provide the full phone number, including the country code.
Extension (Ext.): Phone extension, if needed
Email:

*§ Electronic mail address of the designated individual.

8. Delayed Results (Optional)
A responsible party may delay the deadline for submitting results information if one of the two
certification conditions below applies to the clinical study. Alternatively, the responsible party
may request an extension of the results submission deadline for good cause. The extension must
be granted by the NIH Director.
Delay Results Type [*] : Select one
•

•

•

Certify Initial Approval: Trial studies an FDA-regulated drug product (including a
biological product) or device product that was not approved, licensed or cleared by
FDA for any use before the Primary Completion Date of the trial, and the sponsor
intends to continue with product development and is either seeking, or may at a future
date seek, FDA approval, licensure, or clearance of the drug product (including a
biological product) or device product under study.
Certify New Use: Trial studies an FDA-regulated drug product (including a biological
product) or device product that previously has been approved, licensed, or cleared, for
which the manufacturer is the sponsor of the trial and for which an application or
premarket notification seeking approval, licensure, or clearance of the use being
studied (which is not included in the labeling of the approved, licensed, or cleared
drug, product (including a biologic product) or device product) has been filed or will
be filed within one year with FDA.
Extension: Request, for good cause, an extension of the deadline for submitting
results information

Note: If a responsible party who is both the manufacturer of the drug product (including a
biological product) or device product studied in an applicable clinical trial and the sponsor of
the applicable clinical trial submits a certification under "Certify New Use," that responsible

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party must submit such a certification for each applicable clinical trial that meets the
following criteria: (1) the applicable clinical trial is required to be submitted in an application
or premarket notification seeking approval, licensure, or clearance of a new use; (2) the
applicable clinical trial studies the same drug product (including a biological product) or
device product for the same use as studied in the applicable clinical trial for which the initial
certification was submitted. [42 U.S.C. 282 (j)(3)(E)(v)(II) and 42 CFR 11.44(b)(3)]
Intervention Name(s)
Definition: Provide the name of one or more drugs, biological products or devices to which
the certification applies. For drugs use generic name; for other types of interventions provide
a brief descriptive name. The name(s) entered should match Intervention Name(s) provided
in the protocol section.
FDA Application Number(s)
Definition: Provide at least one FDA application number (for example, NDA, BLA, or PMA
number), if available, when Delay Results Type is "Certify Initial Approval" or "Certify New
Use."
Requested Submission Date [*] (Required when Delay Results Type is "Extension.")
Definition: Estimate of the date on which the clinical study results information will be
submitted, if the Delay Results Type is "Extension".
Explanation [*] (Required when Delay Results Type is "Extension.")
Definition: Description of the reason(s) why clinical study results information cannot be
provided according to the deadline, with sufficient detail to justify good cause for the
extension and to allow for the evaluation of the request. Note that "pending publication" and
delays in data analysis for unspecified causes are not considered good cause for an extension.
Limit: 999 characters.

History of Changes
2017-01-18: Document updated with data element changes per the FDAAA 801 final rule
(42 CFR Part 11).

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