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Listed below are the details for the data element.

FITBIR
1.10
Element Type
Common Data Element
Adverse event start date and time
AdvrsEvntStartDateTime
Short Description
Date (and time, if applicable and known) on which the adverse event was first evident
Definition
Date (and time, if applicable and known) on which the adverse event was first evident
 

Biomedical Terminologies and Standards

Notes
CDISC SDTM variables: AEENDTC End Date/Time of Adverse Event
Creation Date
Historical Notes
Adverse event start date and time
References
No references available

Data Type
Date or Date & Time
Input Restrictions
Free-Form Entry
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Record the date (and time) the adverse event started. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. If a previously recorded AE worsens, a new record should be created with a new start date/time. There should be no AE start date prior to the date of the informed consent. Any AE that started prior to the informed consent date belongs instead in the medical history. If an item recorded on the medical history worsens during the study, the date of the worsening is entered as an AE with the start date/time as the date/time the condition worsened. EPILEPSY: Record the date (and time) the adverse event started. If a previously recorded AE worsens, a new record should be created with a new start date. There should be no AE start date prior to the date of the informed consent. Any AE that started prior to the informed consent date belongs instead in the medical history. If an item recorded on the medical history worsens during the study, the date of the worsening is entered as an AE with the start date as the date the condition worsened. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http: //www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
Preferred Question Text
Start Date
Category Groups and Classifications
DiseaseDomainSub-Domain
Epilepsy Safety Data Adverse Events
General (For all diseases) Safety Data Adverse Events

Classification

Epilepsy :
Supplemental
General (For all diseases) :
Supplemental
Keywords
AE_Mapped , Adverse_Event , See_also , Knowledge_graph , COVID20
Labels

Admin Information


Effective Date
Until Date
Last Change Date
2024-04-24
See Also
AdvrsEvntDuringStudyInd;AdvrsEvntSeverScale;AdverseEvntEndDateTime;AdvrsEvntVerbatimTermText;SeriousAdvrsEvntInd;AdvEvntMedDRALowerLvlTermCode;AdvrsEvntCTCAELowLvlTermName;InjElapsedTime
Submitting Organization Name
NIH/NINDS
Submitting Contact Name
NINDSCDE
Submitting Contact Information
NINDSCDE@emmes.com
Steward Organization Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID

Change History