Toolbox ยป CDE

Common Data Elements

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CDE GroupCDE NameCDE DefinitionCodeListRecommended Data TypeLengthRecommended FormatVersion NumberVersion Date
Adverse EventsAEYNHas the subject had any adverse events during the study?Yes, NoNumber  16/10/2008
Adverse EventsAESPIDLine Number Number  16/10/2008
Adverse EventsAETERMDescription of the adverse event Text  16/10/2008
Adverse EventsAESTDDDay of when the adverse event started Text2dd16/10/2008
Adverse EventsAESTMMMonth of when the adverse event started Text3mmm16/10/2008
Adverse EventsAESTYYYear of when the adverse event started Number4yyyy16/10/2008
Adverse EventsAESTTMTime of when the adverse event started Date/Time 24 hour clock16/10/2008
Adverse EventsAEENDDDay of when the adverse event ended Text2dd16/10/2008
Adverse EventsAEENMMMonth of when the adverse event ended Text3mmm16/10/2008
Adverse EventsAEENYYYear of when the adverse event ended Number4yyyy16/10/2008
Adverse EventsAEENTMTime of when the adverse event stopped Date/Time 24 hour clock16/10/2008
Adverse EventsAESEVIndicate the severity of the adverse event1 = Mild, 2 = Moderate, 3 = SevereNumber  16/10/2008
Adverse EventsAERELIndicate the relationship of the study treatment to the adverse event1 = Not Related, 2 = Possibly Related, 3 = RelatedNumber  16/10/2008
Adverse EventsAEACNIndicate the action take on the adverse event1 = None, 2 = Discontinued Temp., 3 = Discontinued Perm., 4 = Withdrawn from Study, 5 = OtherNumber  16/10/2008
Adverse EventsAEACNOTHIndicate the other action taken on the adverse event Text  16/10/2008
Adverse EventsAEOUTIndicate the outcome of the adverse event1 = Resolved without effects, 2 = Resolved with effects, 3 = Ongoing, 4 = Death, 5 = UnknownNumber  16/10/2008
Adverse EventsAESERIndicate whether or not the adverse event is determined to be "serious" according to the protocol.1 = Yes, 2 = No   16/10/2008
Death ReportDTHRPTDTDate the report was taken. Date dd/mmm/yyyy16/10/2008
Death ReportDTHDTDate of death Date dd/mmm/yyyy16/10/2008
Death ReportDTHTMTime of death Time 24 hour clock16/10/2008
Death ReportDTHCAUSECause of death Text  16/10/2008
Death ReportFORMNDCheck if form not completed Number   6/10/2008
DemographicsINCNTDTDate Informed Consent was signed Date dd/mmm/yyyy16/10/2008
DemographicsASSENTDTDate assent signed Date dd/mmm/yyyy16/10/2008
DemographicsINVSIGInvestigator signature Text3 16/10/2008
DemographicsINVSIGDTDate of the investigator signature Date dd/mmm/yyyy16/10/2008
DemographicsSEXIndicate the sex of the individualMale, FemaleNumber  16/10/2008
DemographicsBRTHDTDate of the individual's birth Date dd/mmm/yyyy16/10/2008
DemographicsRACEIndicate the race of the individualAmerican Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, White, More than one race, Unknown or not reportedNumber  16/10/2008
DemographicsETHNICIndicate the ethnicity of the individualHispanic or Latino, Not Hispanic or Latino, Unknown or not reportedNumber  16/10/2008
DemographicsGESTAGEIndicate the gestational age of the individual at birth Number  16/10/2008
DemographicsGESTAGEUIndicate the unit of the gestational ageDays, Weeks, Months,Number  16/10/2008
DemographicsLIFEDAYSIndicate the days of life of the individual Number  16/10/2008
DemographicsMTRACEIndicate the race of the mother of the individualAmerican Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, White, More than one race, Unknown or not reportedNumber  16/10/2008
DemographicsMTETHNICIndicate the ethnicity of the mother of the individualHispanic or Latino, Not Hispanic or Latino, Unknown or not reportedNumber  16/10/2008
DemographicsPTRACEIndicate the race of the father of the individualAmerican Indian or Alaska Native, Asian, Black or African-American, Native Hawaiian or Other Pacific Islander, White, More than one race, Unknown or not reportedNumber  16/10/2008
DemographicsPTETHNICIndicate the ethnicity of the father of the individualHispanic or Latino, Not Hispanic or Latino, Unknown or not reportedNumber  16/10/2008
Dosing DiaryFORMNDCheck if form not completed Number   6/10/2008
Dosing DiaryDOSSPIDLine Number Number  16/10/2008
Dosing DiaryDOSDTDosing Date for Dose 1 Date dd/mmm/yyyy16/10/2008
Dosing DiaryDOS1TMDosing Time for Dose 1 Time 12 hour clock16/10/2008
Dosing DiaryDOS1TMUDosing Time AM/PM for Dose 1 Number AM, PM16/10/2008
Dosing DiaryDOS1PILLAmount of Dose for Dose 1 Number  16/10/2008
Dosing DiaryDOS1NODose Number Number  16/10/2008
Dosing DiaryDOS2TMDosing Time for Dose 2 Time 12 hour clock16/10/2008
Dosing DiaryDOS2TMUDosing Time AM/PM for Dose 2 Number AM, PM16/10/2008
Dosing DiaryDOS2PILLAmount of Dose for Dose 2 Number  16/10/2008
Dosing DiaryDOS2NODose Number Number  16/10/2008
Dosing DiaryDOS[N]TMDosing Time for Dose[N] Time 12 hour clock16/10/2008
Dosing DiaryDOS[N]TMUDosing Time AM/PM for Dose [N] Number AM, PM16/10/2008
Dosing DiaryDOS[N]PILLAmount of Dose for Dose [N] Number  16/10/2008
Dosing DiaryDOS[N]NODose Number Number  16/10/2008
Enrollment and RandomizationIEYNResponse for whether the subject was eligible for the study based on Inclusion and Exclusion criteriaYes; NoNumber   6/10/2008
Enrollment and RandomizationENROLLDTDate enrolled Date dd/mmm/yyyy 6/10/2008
Enrollment and RandomizationRANDYNWas the subject randomized?Yes; NoNumber   6/10/2008
Enrollment and RandomizationRANDDTDate randomized Date dd/mmm/yyyy 6/10/2008
Enrollment and RandomizationRANDNOIf eligible and not randomized, reasonFailed to return; Declined participate; OtherNumber   6/10/2008
Enrollment and RandomizationRANDNOXIf eligible and not randomized, reason other specify Text200  6/10/2008
Enrollment and RandomizationFORMNDForm not completed Number   6/10/2008
Inclusion Exclusion CriteriaINCLUS01Response for whether the subject met inclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaINCLUS02Response for whether the subject met inclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaINCLUS03Response for whether the subject met inclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaINCLUS04Response for whether the subject met inclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaINCLUS05Response for whether the subject met inclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaINCLUS06Response for whether the subject met inclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaEXCLUS01Response for whether the subject met exclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaEXCLUS02Response for whether the subject met exclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaEXCLUS03Response for whether the subject met exclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaEXCLUS04Response for whether the subject met exclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaEXCLUS05Response for whether the subject met exclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaEXCLUS06Response for whether the subject met exclusion requirements for this studyYes, NoNumber  16/10/2008
Inclusion Exclusion CriteriaIEYNResponse for whether the subject met the eligibility requirements for this study.Yes, NoNumber  16/10/2008
Lab Test TrackingLBSPIDLine Number Number  16/10/2008
Lab Test TrackingLBNDCheck if no labs were collected for this patient Number  16/10/2008
Lab Test TrackingLBSTATCheck whether each Lab test is Done or Not DoneDone, Not DoneNumber  16/10/2008
Lab Test TrackingLBTESTName of testSodium, Potassium, Chloride and other lab testsText50 16/10/2008
Lab Test TrackingLBREFIDAccession Number Text50 16/10/2008
Lab Test TrackingLBDTLab collection Date Date dd/mmm/yyyy16/10/2008
Lab Test TrackingLBTMLab Collection Time Time 24 hour clock16/10/2008
Lab Test TrackingLBREASNDComments if Not Done Text200 16/10/2008
Laboratory ResultsLBSPIDLine Number Number  16/10/2008
Laboratory ResultsLBTESTName of lab testSodium, potassium,and other lab testsText50 16/10/2008
Laboratory ResultsLBDTDate of Lab Collection Date dd/mmm/yyyy16/10/2008
Laboratory ResultsLBTMTime of Lab Collection Time 24 hour clock16/10/2008
Laboratory ResultsLBORRES Lab results Text50 16/10/2008
Laboratory ResultsLBORRESUUnits of Lab Results Text50 16/10/2008
Laboratory ResultsLBNRINDReference Range IndicatorLow, Normal or HighNumber  16/10/2008
Laboratory ResultsLBABCSClinical Significance Text200 16/10/2008
Laboratory ResultsLBNDCheck here is no labs were collected for this subject Number   6/10/2008
Medical HistoryFORMNDForm not completed Number   6/10/2008
Medical HistoryMHSPIDLine Number Number  16/10/2008
Medical HistoryMHCATIndicate the code the condition/disease affects.01 Head, Eye, Ear, Nose, Throat, 02 Respiratory, 03 Cardiovascular, 04 Gastrointestinal, 05 Genitourinary, 06 Musculoskeletal, 07 Neurological, 08 Endocrine/Metabolic, 09 Blood/Lymphatic, 10 Dermatologic, 11 Psychiatric, 12 Allergy, 91 OtherNumber  16/10/2008
Medical HistoryMHCATXIndicate the condition/Disease if the Code is Other Text100 16/10/2008
Medical HistoryMHTERMRecord all past and/or concomitant medical conditions or surgeries. Text100 16/10/2008
Medical HistoryMHSTDDDay when the condition/disease started Text2dd16/10/2008
Medical HistoryMHSTMMMonth of when the condition/disease started Text3mmm16/10/2008
Medical HistoryMHSTYYYear of when the condition/disease started Number yyyy16/10/2008
Medical HistoryMHONGIndicate if the condition/disease as being Current or Resolved.Current, ResolvedNumber  16/10/2008
Pharmacokinetic Blood SamplingPCDTBlood sampling date Date dd/mmm/yyyy 6/10/2008
Pharmacokinetic Blood SamplingPCTPTTMBlood sampling proposed time Time 24 hour clock 6/10/2008