ClinicalTrials.gov "Basic Results" Data Element Definitions (DRAFT)

November 2013

The "basic results" data element definitions and requirements currently included in ClinicalTrials.gov represent the National Institutes of Health's (NIH's) current thinking on this topic, and were developed in response to the provision contained within FDAAA that required the Agency to develop a "basic results" databank within one year of enactment. They do not create or confer any rights for or on any person and do not operate to bind NIH, the Department of Health and Human Services or the public. NIH will interpret these "basic results" reporting requirements in regulations or guidance to be issued at a later date. Prior to the issuance of draft regulations or guidance for comment, comments on the existing ClinicalTrials.gov "basic results" data element definitions and requirements are welcome and will be considered by the Agency in drafting a Notice of Proposed Rulemaking. Comments should be addressed to register@clinicaltrials.gov. Please include "Comments on ClinicalTrials.gov Results Requirements" in the subject line.


*   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 * : Point of contact for scientific information about the posted clinical trial results.

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 * : Full name of the designated individual's organizational affiliation.

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. (ie, the Study Completion Date from the Protocol Data Elements)

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
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

Arm/Group Title * : Label used to identify the arm or comparison group.
Minimum length is 4 characters. Titles shorter than the minimum are unlikely to sufficiently describe the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: >=4 and <=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.

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

[
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.

Milestone Title: [*] : Label describing milestone
(Limit: 40 characters)

Milestone Data [*] (per milestone, per arm/group): Number of participants to reach the milestone.

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
  • 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)

Reason Not Completed Data [*] (per reason, per arm/group): Number of participants for 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:

Arm/Group *
Definition: Arms or comparison groups in a trial

Arm/Group Title * : Label used to identify the arm or comparison group.
Minimum length is 4 characters. Titles shorter than the minimum are unlikely to sufficiently describe the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: >=4 and <=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)

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 Analysis Population Description
Definition: Explanation of how the number of participants for analysis was determined.
(Limit: 350 characters)

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.
Study-Specific Baseline Measure Title(s) [*] : If "Study-Specific Measure" is chosen, provide the name of the measure. Examples: Systolic blood pressure; Prior anti-depressant 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: 600 characters)

Measure Type * : Select one
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.
  • Not Applicable
  • Standard Deviation
  • Inter-Quartile Range
  • Full Range

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

Category Title * : (required for categorical data)
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.

NA (Not Available) Explanation [*] - required when NA is reported. : Explain why baseline measure data (i.e., any "Number" or "Descriptive Statistics" value) are Not Available.
(Limit: 250 characters)

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:

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.


Arm/Group *
Definition: Arms or comparison groups in a trial


Arm/Group Title * : Label used to identify the arm or comparison group.
Minimum length is 4 characters. Titles shorter than the minimum are unlikely to sufficiently describe the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: >=4 and <=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)

Number of Participants Analyzed * (per outcome measure, per arm/group)
For the outcome reported

Type of Units Analyzed [*] If analysis is not based on participants, specify the type of units analyzed (e.g., eyes, lesions, implants).
(Limit: 40 characters)
Number of Units Analyzed [*] - required when "Type of Units Analyzed" is reported (per outcome measure, per arm/group)
For the outcome data reported, the number of units analyzed when analysis is not based on participants.


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 outcome measure information from the protocol section of the record will be copied into the results section the first time results are created.

Outcome Measure Type * : Select one
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.
  • 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 * : Name of outcome measure
(Limit: 255 characters)

Outcome Measure Time Frame * : Time point(s) at which outcome measure was assessed.
(Limit: 255 characters)

Outcome Measure Description: Additional information about outcome measure.
(Limit: 999 characters)

Outcome Measure Safety Issue? (Y/N) (FDAAA) : Is this outcome measure assessing a safety issue? Select: Yes/No

Measure Type * : Select one 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, 95% confidence interval, 90% confidence interval or geometric coefficient of variation

NA (Not Available) Explanation [*] - required when NA is reported. : Explain why outcome data (i.e., any "Number" or "Descriptive Statistics" value) are Not Available.
Example: (Time-to-event outcome) The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
(Limit: 250 characters)

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"). (For other types of analyses, including superiority or single-group, 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.
  • 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.

Estimation Parameter [*] : Select one
  • 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)

Estimated Value [*] (if provided, Estimation Parameter required)

Confidence Interval [*] (if applicable, provide the following sub-elements):

Level [*] : Expressed as a percentage.

Number of Sides : Select 1-sided or 2-sided.

Lower Limit [*] : (required if confidence interval is 2-sided or if confidence interval is 1-sided and no Upper Limit is entered.)

Upper Limit [*] : (required if confidence interval is 2-sided or if confidence interval is 1-sided and no Lower Limit is entered.)

NA (Not Available) Explanation [*] : (required when NA is reported as upper-limit of 2-sided confidence interval.) Explain why the upper limit data are Not Available.
Example: (Time-to-event outcome) The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
(Limit: 250 characters)

Dispersion of Confidence Interval

Parameter Dispersion Type : Select one.
  • 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 * : 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. (See Adverse Events definition below).

  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.

Arm/Group *
Definition: Arms or comparison groups in a trial

Arm/Group Title * : Label used to identify the arm or comparison group.
Minimum length is 4 characters. Titles shorter than the minimum are unlikely to sufficiently describe the arm or comparison group.
Examples: fluoxetine; sertraline; drug-eluting stent; placebo
(Limit: >=4 and <=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)

Time Frame for Adverse Event Reporting
Definition: Period in which the reported adverse event data were collected (e.g., 1 year, 6 months)
(Limit: 255 characters)

Adverse Event Reporting Additional Description
Definition: Additional relevant information about adverse event collection, including details about the method of systematic assessment (e.g., daily questionnaire)
(Limit: 350 characters)

Source Vocabulary Name for Table Default
Definition: Default value for Source Vocabulary Name to be applied to all adverse event terms entered in the "Serious" and "Other" adverse event tables, unless otherwise specified (e.g., SNOMED CT, MedDRA 10.0).
(Limit: 20 characters)

Assessment Type for Table Default
Definition: Default value for Adverse Event Assessment Type (Systematic or Non-Systematic Assessment Type) to be applied to all adverse event terms entered in the "Serious" or "Other" adverse event tables, unless otherwise specified.

Adverse Events
Definition: Unfavorable changes in health, 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.
  1. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
  2. 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: 100 characters)

Source Vocabulary Name : Standard terminology, controlled vocabulary, or classification and version from which adverse event terms are drawn, if any (e.g., 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)

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."

Assessment Type : Method used to assess the adverse event. Select one or leave blank to indicate that the value specified as the Assessment Type for Table Default should be used.
Adverse Event Term Additional Description : Additional relevant information about the adverse event, including any deviation from the Time Frame for Adverse Event Reporting.
(Limit: 250 characters)

Total Number Affected by Any Serious Adverse Event * (per arm/group): Overall number of participants affected by one or more Serious Adverse Events.

Total Number of Participants at Risk for Serious Adverse Events * (or Number of Participants at Risk for each Serious Adverse Event Term required)
(per arm/group) : Overall number of participants included in the assessment of serious adverse events during the trial (i.e., the denominator for calculating frequency of serious adverse events)

Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events *
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. The number must be less than or equal to the allowed maximum (5%), and must not include any symbols (e.g., >= , %).
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 Frequency Threshold * (per arm/group): Overall number of participants affected by one or more Other (Not Including Serious) Adverse Events above the specified Frequency Threshold (e.g., 5%) reported in the table.

Total Number of Participants at Risk for Other (Not Including Serious) Adverse Events * (or Number of Participants at Risk for each Other, Not Including Serious, Adverse Event Term required)
(per arm/group) : Overall number of participants included in the assessment of other, not including serious, adverse events during the trial (i.e., the denominator for calculating frequency of other, not including serious, adverse events).


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). Leave blank to indicate that the value specified as the total at risk in the arm/group for the table should be used. Note, when the number at risk in the arm/group is blank, the total at risk in the arm/group for the table must be entered.



Delayed Results - OPTIONAL: A responsible party may delay the deadline for submitting results information under Section 801 of the Food and Drug Administration Amendments Act if one of the two certification conditions below applies to the applicable clinical trial. 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. To delay the results submission deadline using either of these mechanisms, all [*]-marked data elements are required, except as noted below.

Delay Results Type [*] : Select one

Note: If a manufacturer (who is the responsible party) makes a certification under "Certify New Use" the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report to the FDA for licensure, approval, or clearance of the use studied in the clinical trial. [42 U.S.C. 282 (j)(3)(E)(v)(II)]

Intervention Name(s) [*] : Required when Delay Results Type is "Certify Initial Approval" or "Certify New Use."
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):
Provide at least one FDA application number (e.g., 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."
Provide the month and year when results are expected to be submitted.

Explanation [*] : Required when Delay Results Type is "Extension."
Provide a written explanation that demonstrates good cause for the extension. Provide sufficient information to allow for evaluation of the request. Note that "pending publication" is not considered "good cause" for an extension. (Limit: 999 characters)