Field NameDefinition of the Data Element
NCT IDThe ClinicalTrials.gov identifier
Other IDsOther identification numbers assigned to the protocol, including unique identifiers from other registries and NIH grant numbers
TitleOfficial name of the protocol provided by the study principal investigator or sponsor
AcronymAcronym or initials used to identify this study
Funded BysFunding source as industry, NIH, U.S. Federal Government, Network, or other
SponsorsName of primary organization that oversees implementation of study and is responsible for data analysis
Recruitment# Enrolling by invitation: participants are being (or will be) selected from a predetermined population
# Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but participants are not currently being recruited or enrolled
# Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
# Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
# Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
# Withdrawn: study halted prematurely, prior to enrollment of first participant
ConditionsPrimary disease or condition being studied, or focus of the study. Diseases or conditions should use the National Library of Medicine’s Medical Subject Headings (MeSH) controlled vocabulary when possible.
Study TypesInterventional or observational studies
Study DesignsPurpose, phase, treatment allocation, masking of the treatment status; type of primary outcome or endpoint that the protocol is designed to evaluate
PhasesPhase of investigation, as defined by the U.S. FDA for trials involving investigational new drugs
Study Results
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Participant Flow

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Baseline Characteristics

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Outcome Measures and Statistical Analyses

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Adverse Events Information

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Administrative Information

Interventions
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Drug (including placebo)

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Device (including sham)

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Biological/Vaccine

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Procedure/Surgery

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Radiation

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Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

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Genetic (including gene transfer, stem cell and recombinant DNA)

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Dietary Supplement (e.g., vitamins, minerals)

Outcome MeasuresSpecific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
GenderPhysical gender of individuals who may participate in the protocol
Age GroupsAge of participants
EnrollmentNumber of subjects in the trial
First ReceivedDate the protocol information was received
Start DateDate that enrollment to the protocol begins
Completion DateFinal date on which data was (or is expected to be) collected
Last UpdatedDate the protocol information was updated
Last VerifiedDate the protocol information was last verified
Primary Completion DateThe date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated
Why Study Stopped?A brief explanation of why suspended, terminated or withdrawn studies have been halted or terminated

From: Finding Grey Literature Evidence and Assessing for Outcome and Analysis Reporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health Care Program

Cover of Methods Guide for Effectiveness and Comparative Effectiveness Reviews
Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet].

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