ClinicalTrials

ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

ClinicalTrials

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ClinicalTrials.gov "Basic Results"
Data Element Definitions
November 5, 2008

*
[*]

Required by ClinicalTrials.gov
Conditionally required by ClinicalTrials.gov

(FDAAA) May be required to comply with US Public Law 110-85, Section 801

1. Results Point of Contact
posted clinical trial results.

* : Point of contact for scientific information about the

Name or Official Title : For the designated individual. Note that this may be a
specific person's name (e.g., Dr. Jane Smith) or a position title (e.g., Director of Clinical
Trials)
Organization Name
affiliation.

* : Full name of the designated individual's organizational

Phone
: (or "Email" required) Office phone of the designated individual. Use the
format 123-456-7890 within the United States and Canada. Otherwise, provide the
country code and phone number.
ext. : Phone extension, if needed
Email

* : (or "Phone" required) Electronic mail address of the designated individual.
*

2. Certain Agreements : Information certifying 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 trial, to discuss the results of the
trial 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 trial. 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? (Y/N) : If all principal investigators are
employees of the sponsor, select "Yes" and skip the remaining questions. If any principal
investigator (PI) is not an employee of the sponsor, select "No" and answer the remaining
questions.
Results Disclosure Restriction on PI(s)? (Y/N) [*] If there is an agreement between
the sponsor (or its agent) and any non-employee PI(s) that restricts the PI's rights to
discuss or publish trial results after the trial is completed, select "Yes" and select a
"Restriction Type." Trial completion is defined as the final date on which data were
collected (see Study Completion Date definition).
If there are agreements with multiple non-employee PIs and there is a disclosure
restriction on at least one PI, select "Yes" and answer the remaining question. If there are
varying agreements with PIs, choose the type below that represents the most restrictive of
the agreements (e.g., the agreement with the greatest embargo time period).
PI Disclosure Restriction Type : Select one
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The only disclosure restriction on the PI is that the sponsor can review results
communications prior to public release and can embargo communications
regarding trial results for a period that is less than or equal to 60 days from the
time submitted to the sponsor for review. The sponsor cannot require changes to
the communication and cannot 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 trial results for a period that is more than 60 days but less than or
equal to 180 days from the time submitted to the sponsor for review. The sponsor
cannot require changes to the communication and cannot extend the embargo.
Other disclosure agreement that restricts the right of the PI to discuss or publish
trial results after the trial is completed

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

3. Participant Flow : Progress of research participants through each stage of a trial in
a tabular format, including the number of participants who dropped out of the clinical
trial. (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 trial 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 (e.g., medical clinic), to
provide context.
(Limit: 350 characters)
Pre-assignment Details
Definition: Description of any significant events and approaches for the overall study
(e.g., wash out, run-in, transition) following participant enrollment, but prior to group
assignment. For example, an explanation of why enrolled participants were excluded
from the trial before assignment to groups.
(Limit: 350 characters)

Arm/Group
Definition: Arms or comparison groups in a trial
(Note that arm information from the protocol section will be copied into the results
section the first time results are created. After that, such information may be changed in
the results section at any time. However, any changes in the results section will not be
reflected in the protocol section - you will also need to update the protocol section, as
appropriate.)

Arm/Group Title : Label used to identify the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: 62 characters)
Arm/Group Description : Brief description of the arm or comparison group to
distinguish it from other arms/groups in the trial.
Examples: fluoxetine, 20mg qhs; Sirolimus-eluting stent (SES) implanted using standard
percutaneous coronary intervention (PCI) technique via the femoral approach.
(Limit: 999 characters)

Period(s)
Definition: Discrete stages of a clinical trial during which numbers of participants at
specific significant events or points of time are reported. If only one period, use Overall
Study for "Period Title."
There is no limit to the number of periods that may be used to describe a single trial.
Each subsequent period represents a trial stage following the previous period. That is,

participants "flow" from earlier to later periods. All results sections must cover
participant flow from initial assignment to arms/groups to completion of the trial.

Period Title
Definition: Title describing a stage of the trial. If only one period is defined, the default
title is "Overall Study." When a trial has more than one period, none of the period titles
should be "Overall Study." Example of two periods: sertraline then placebo; placebo then
sertraline;
(Limit: 40 characters)

Milestone(s)
Definition: Specific events or time points in the trial when the numbers of participants 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.
STARTED

* : Number of participants at the beginning of the period.

Comments : Additional information about the STARTED milestone.
(Limit: 100 characters)
COMPLETED

* : Number of participants at the end of the period.

Comments : Additional information about the COMPLETED milestone.
(Limit: 100 characters)
[Not Completed : Number of participants that did not complete the period. Calculated
automatically by subtracting COMPLETED from STARTED]
Additional Milestone(s) : Any number of milestones may be added between the two
required milestones, STARTED and COMPLETED.

: Label describing milestone
Milestone Title:
(Limit: 40 characters)
Milestone Data
milestone.

* (per milestone, per arm/group): Number of participants to reach the

Comments : Additional information about the milestone.
(Limit: 100 characters)

Reason Not Completed : Additional information about participants who did not
complete the period. If any are provided, the total number of participants accounted for
by all reasons must equal the number of participants listed under "Not Completed."
Reason Not Completed Type [*] : Select one for each reason not completed
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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 [*] : If "Other" is selected, provide label
(Limit: 40 characters)

* (per reason, per arm/group): Number of participants for

Reason Not Completed Data
each arm or comparison group.

4. Baseline Characteristics : A table of demographic and baseline data for the entire
trial population and for each arm or comparison group. Note that only baseline measures
for Age and Gender are required; all other baseline measures are optional. The table cells
accommodate different types of data:
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Categorical - create customized categories and then report a count or a measure of
central tendency and a measure of dispersion for each category by arm or
comparison group
Continuous - report a measure of central tendency and a measure of dispersion for
each arm or comparison group
Time-to-Event Data - report as either (1) continuous data (e.g., mean time to event
with measure of dispersion) or (2) categorical data at different time points by arm
or comparison group

the results section at any time. However, any changes in the results section will not be
reflected in the protocol section - you will also need to update the protocol section, as
appropriate.)

Overall Number of Baseline Participants (per arm/group) : Overall number of
participants for which baseline characteristics were measured for all baseline measures
reported. Note that if the participant population differs for a particular baseline measure,
the number of participants should be included in the Baseline Measure Description.

Baseline Measure(s)
Definition: Name and description of a characteristic measured at the beginning of the
trial. Note that baseline measure data for "Age" (at least one of the three types) and
"Gender" are required. There is no limit to the number of additional "Study-Specific
Measures" that may be provided.

Baseline Measure Title : Select one. Note that baseline measures for at least one
"Age" and "Gender" title are required.
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Study-Specific Measure (as many as needed)

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Age

* (at least one of the following):

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Gender
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Age, Continuous: example - mean age in years
Age, Categorical:
• <=18 years
• >18 and <65 years
• >=65 years
Age, Customized: example - number in each category
(birth-10 years, 11-20 years, 21-30 years, etc.)

* (one of the following):
Gender, female, male
Gender, Customized

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Race (NIH/OMB): U.S. National Institutes of Health and U.S. Office of
Management and Budget Classification Categories
Race, Customized
Ethnicity (NIH/OMB): U.S. National Institutes of Health and U.S. Office of
Management and Budget Classification Categories
Ethnicity, Customized
Region of Enrollment

Study-Specific Baseline Measure Title(s) [*] : If "Study-Specific Measure" is chosen,
provide the name of the measure. Examples: Systolic blood pressure; Prior antidepressant treatment.
(Limit: 100 characters)
Baseline Measure Description : Additional information about the measure, such as
details about the collection method or participant population, if different from Overall
Number of Baseline Participants.
(Limit: 350 characters)
Measure Type
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* : Select one

Number (e.g., number of participants)
Measure of Central Tendency, if a continuous measure is reported
• Mean
• Median
• Least Squares Mean
• Geometric Mean
• Log Mean

Measure of Dispersion : Select one. Please select "Not Applicable" if the Measure
Type is "Number". Please do NOT select "Not Applicable" for other measure types.
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Not Applicable
Standard Deviation
Inter-Quartile Range
Full Range

Unit of Measure
: e.g., participants, mm Hg
(Limit: 40 characters)

: (required for categorical data)
Category Title
Definition: Name of distinct category for a baseline measure, if reporting categorical
data.
(Limit: 50 characters)

Baseline Measure Data : (per baseline measure and per arm/group)
Definition: Baseline measure data (either "Number" or "Descriptive Statistics").
Number

* : (or Descriptive Statistics): e.g., number of participants

Descriptive Statistics

* : (or Number)

Central Tendency Value : mean, median, least squares mean, geometric mean, or log
mean.
Dispersion Value(s) : standard deviation, inter-quartile range, or full range.

5. Outcome Measures : A table of values for each of the outcome measures by arm
(i.e., initial assignment of groups to interventions) or comparison group (i.e., groups
receiving interventions regardless of initial assignment). The table cells accommodate
different types of data:
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Note that data reported for each outcome measure will be displayed as a separate table.
All statistical analyses on those data will be associated with that table.

reflected in the protocol section - you will also need to update the protocol section, as
appropriate.)

* (per outcome measure, per arm/group)

Analysis Population Description
Definition: Explanation of how the number of participants for analysis was determined.
Indicate whether the analysis was "per protocol", "intention to treat (ITT)", or another
method. Also provide relevant details such as imputation technique (e.g., Last
Observational Carried Forward [LOCF]), as appropriate.
(Limit: 350 characters)

Outcome Measure
Definition: Name and description of the measure used to assess the effect of experimental
variables in the trial
(Note that primary and secondary outcome measure information from the protocol
section of the record will be copied into the results section the first time results are
created. After that, "Outcome Measure Type," "Outcome Measure Title," "Outcome
Measure Time Frame" and "Outcome Measure Safety Issue? (Y/N)" for primary or
secondary outcome measures may only be changed in the results section.)
Outcome Measure Type
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* : Select one

Primary Outcome Measure (from Protocol section)
Secondary Outcome Measure (from Protocol section)
Other Pre-specified Outcome Measure
Post-Hoc Outcome Measure

Outcome Measure Reporting Status : Indicate whether posting results data for this
outcome measure. Note that each record is required to have "Posted" data for at least one
outcome measure.
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Posted: Results data included
Not Posted: Results data not included

Anticipated Posting Date : If "Outcome Measure Reporting Status" is "Not Posted",
then indicate the expected month and year it will be "Posted."
Outcome Measure Title
(Limit: 255 characters)

* : Name of outcome measure

Outcome Measure Time Frame
assessed.
(Limit: 255 characters)

* : Time point(s) at which outcome measure was

Outcome Measure Description : Additional information about outcome measure.
(Limit: 350 characters)
Outcome Measure Safety Issue? (Y/N) (FDAAA) : Is this outcome measure assessing a
safety issue? Select: Yes/No
Measure Type
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* : Select one

Number (e.g., number of participants)
Measure of Central Tendency, if a continuous measure is reported
• Mean
• Median
• Least Squares Mean
• Geometric Mean
• Log Mean

Measure of Dispersion : Select one. Please select "Not Applicable" if the
Measure Type is "Number". Please do NOT select "Not Applicable" for other
Measure Types.
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Not Applicable
Standard Deviation

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Inter-Quartile Range
Full Range
Standard Error
95% Confidence Interval

Unit of Measure
: e.g., participants, mm Hg
(Limit: 40 characters)

Category Title
: (required for categorical data, as many as needed)
Definition: Name of distinct category used to measure outcome, if reporting categorical
data.
(Limit: 50 characters)

Outcome Data : (per category, per arm/group)
Definition: Outcome measure summary data (either "Number" or "Descriptive
Statistics").
Number

* : (or Descriptive Statistics): e.g., number of participants

Descriptive Statistics

* : (or Number)

Central Tendency Value : mean, median, least squares mean, geometric mean, or log
mean
Dispersion Value(s) : standard deviation, inter-quartile range, full range, standard error,
or 95% confidence interval
Statistical Analyses - OPTIONAL; if statistical analysis information is provided,
then [*]-marked data elements are required.
Definition: One or more statistical analyses conducted on the outcome data.
If a statistical analysis is reported, the following data elements are required: "Comparison
Group Selection," "Non-inferiority or Equivalence Analysis," and at least "P-Value" or
"Confidence Interval" with the associated information.
Statistical Analysis Overview : Summary description of the analysis performed.
Comparison Group Selection [*] : Identifies the arms or comparison groups involved
in the statistical analysis (check all to indicate an "omnibus" analysis)

Comments : Additional details about the statistical analysis, such as null hypothesis and
description of power calculation
(Limit: 500 characters)
Non-inferiority or Equivalence Analysis? (Y/N) [*] : Identifies whether the analysis
is a test of non-inferiority or equivalence (Choose "Yes") or superiority (Choose "No").
Comments : If, "Yes", provide additional details, including details of the power
calculation (if not previously provided), definition of non-inferiority margin, and other
key parameters
(Limit: 500 characters)
Statistical Test of Hypothesis : Procedure used for statistical analysis of outcome data
and calculated p-value.
P-Value [*] : (if applicable): Calculated p-value given the null-hypothesis
Comments : Additional information, such as whether or not the p-value is adjusted for
multiple comparisons and the a priori threshold for statistical significance
(Limit: 250 characters)
Method [*] : (required if "P-Value" is reported): Select a statistical test.
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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 [*] : If "Other" is selected, provide name of statistical test.
(Limit: 40 characters)
Comments : Any other relevant information, such as adjustments or degrees of freedom
(Limit: 150 characters)
Method of Estimation : Procedure used to estimate effect of intervention.
Confidence Interval [*] : (if applicable, provide all five of the following sub-elements)
If the confidence interval is one-sided, also provide the Estimated Value in either the
Lower Limit or Upper Limit.
Level [*] : Expressed as a percentage. (Default "95").
Lower Limit [*]
Upper Limit [*]
Estimated Value [*] (if provided, Estimation Parameter required)
Estimation Parameter [*] : Select one
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Cox Proportional Hazard
Hazard Ratio (HR)
Hazard Ratio, log
Mean Difference (Final Values)
Mean Difference (Net)
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 [*] : If "Other" is selected, provide name
(Limit: 40 characters)
Dispersion of Confidence Interval
Parameter Dispersion Type : Select one.

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Standard Deviation
Standard Error of the Mean

Dispersion Value
Estimation Comments : Any other relevant estimation information, including the
direction of the comparison (e.g., describe which arm or comparison group represents the
numerator and denominator for relative risk)
(Limit 250 characters)

6. Overall Limitations and Caveats : If appropriate, describe significant limitations of
the trial. Examples: Early termination leading to small number of subjects analyzed;
Technical problems with measurement leading to unreliable or uninterpretable data.
(Limit 250 characters)
7. Adverse Events - OPTIONAL; if adverse events information is provided, then all

[*]-marked data elements are required.
Two types of adverse event data are to be reported
1. 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 of the clinical trial
2. 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 within any arm of the clinical trial, grouped by organ
system, with number and frequency of such events in each arm of the clinical
trial.
Adverse events are unfavorable changes in health (or side effects), including abnormal
laboratory findings, that occur in trial participants during the clinical trial or within a
specified period following the trial.
Serious Adverse Events include adverse events that result in death, require either
inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a
persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other
important medical events, based upon appropriate medical judgment, may also be
considered Serious Adverse Events if a trial participants' health is at risk and intervention
is required to prevent an outcome mentioned.
Arm/Group [*]
Definition: Arms or comparison groups in a trial
(Note that arm information from the protocol section will be copied into the results
section the first time results are created. After that, such information may be changed in
14

the results section at any time. However, any changes in the results section will not be
reflected in the protocol section - you will also need to update the protocol section, as
appropriate.)
Arm/Group Title [*] Label used to identify the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: 62 characters)
Arm/Group Description: Brief description of the arm or comparison group to
distinguish it from other arms/groups in the trial.
Examples: fluoxetine, 20mg qhs; Sirolimus-eluting stent (SES) implanted using standard
percutaneous coronary intervention (PCI) technique via the femoral approach.
(Limit: 999 characters)

Adverse Events
Definition: Unfavorable changes in health (or side effects), including abnormal
laboratory findings, that occur in trial participants during the clinical trial or within a
specified period following the trial.
Two types of adverse event data are to be reported: "Serious" and "Other (Not Including
Serious)" adverse events.
Serious Adverse Events include adverse events that result in death, require either
inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a
persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other
important medical events, based upon appropriate medical judgment, may also be
considered Serious Adverse Events if a trial participants' health is at risk and intervention
is required to prevent an outcome mentioned.
Other (Not Including Serious) Adverse Events are those that are not Serious Adverse
Events that exceed a frequency threshold.
Adverse Event Term [*] : Word or phrase describing an adverse event.
(Limit: 62 characters)
Source Vocabulary Name : Standard terminology, controlled vocabulary, or
classification and version from which adverse event terms are drawn, if any (e.g., MeSH
2007, SNOMED CT 2007, ICD9CM_2007, MedDRA 10.0)
(Limit: 14 characters)
Organ System [*] : 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

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Cardiac disorders
Congenital, familial and genetic disorders
Ear and labyrinth disorders
Endocrine disorders
Eye disorders
Gastrointestinal disorders
General disorders
Hepatobiliary disorders
Immune system disorders
Infections and infestations
Injury, poisoning and procedural complications
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
Psychiatric disorders
Renal and urinary disorders
Reproductive system and breast disorders
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
Vascular disorders

Assessment Type [*] : Method used to assess the adverse event. 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
Spontaneous Report: Any non-systematic method for determining whether or not
adverse events have occurred, such as self-reporting by participants or occasional
assessment/testing

Total Number Affected by Any Serious Adverse Event [*] (per arm/group): Overall
number of participants affected by one or more Serious Adverse Events.
Frequency Threshold for Reporting Other (Not Including Serious) Adverse Event

[*]
Definition: The frequency of Other (Not Including Serious) Adverse Events that, when
exceeded within any arm or comparison group, are reported in the results database for all
arms or comparison groups.
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 [*]
(per arm/group): Overall number of participants affected by one or more Not Including
Serious Adverse Events reported in the table.

Adverse Event Data [*] (per adverse event, per arm/group)
Number of Affected Participants [*] : Number of participants experiencing at least
one event being reported
Number of Events: Number of occurrences of the adverse event being reported
Number of Participants at Risk [*] : Number of participants assessed for adverse
events during the trial (i.e., the denominator for calculating frequency of adverse events)

File Type	application/pdf
File Title	ClinicalTrials
Author	atse
File Modified	2008-12-19
File Created	2008-12-19