This form structure is an organized set of data definitions for a form that has not been copyrighted

 General Details

Title:
End of Study Disposition
Short Name:
ESD
Description:
"The Study Discontinuation/Completion Form captures each participant’s/subject’s status at the end of the study. It provides an anchor for quality control and analysis. The status, in aggregate, also defines the study population -- those completed, lost, etc."
Disease:
Traumatic Brain Injury
Organization:
NIH
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2019-02-28
Version:
1.0
Date Created:
2016-04-15
Owner:
Number of Data Elements:
22
eForms:
N

 Documentation


 Groups & Attached Data Elements

Logically grouped data elements with defined frequency at which they repeat.

# Title Short Description Variable Name Required? Type
1 GUID   Global Unique ID which uniquely identifies a subject GUID Required CDE
2 Subject identifier number   An identification number assigned to the participant/subject within a given protocol or a study. SubjectIDNum Optional CDE
3 Age in years   Value for participant's subject age recorded in years. AgeYrs Recommended CDE
4 Vital status   Status of participant/subject as alive or dead VitStatus Optional CDE
5 Visit date   Actual interview or visit date VisitDate Recommended CDE
6 Site name   The name of the site for the study SiteName Recommended CDE
7 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study CaseContrlInd Optional CDE
9 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

Form Administration (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Language form administration ISO code  Code (ISO 639-2) for the language that was used for CRF/instrument/scale/etc. administration LangCRFAdministratISOCode Recommended CDE
2 Language form administration ISO code other text  The free-text field related to 'Language used for CRF/instrument/scale/etc. administration ISO code' specifying other text. LangCRFAdministratISOCodeOTH Recommended CDE
3 Context type  The context to which the questions were answered ContextType Recommended CDE
4 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
5 Data source  Source of the data provided on the case report form DataSource Recommended CDE
6 Data source other text  The free-text field related to Data source specifying other text. Source of the data provided on the case report form DataSourceOTH Recommended CDE

End of Disposition (Appears At Least 1 Time)

# Title Short Description Variable Name Required? Type
1 Off study date and time  Date (and time, if applicable and known) when participant/subject completes study or is prematurely withdrawn from study (i.e., is not being followed and will not receive intervention/treatment) OffStdyDateTime Recommended CDE
2 Off study reason  Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). OffStdyRsn Recommended CDE
3 Days since randomization  Days since randomization DaysSinceRandomization Optional UDE
4 Off study intervention prematurely indicator  Indicator that participant/subject discontinued study intervention before planned end of study OffStdyIntrvntPrematureInd Recommended CDE
5 Last study intervention date and time  Date (and time, if applicable) of the last known study intervention that the participant/subject received LstStdyIntrvntDateTime Recommended CDE
6 Off study intervention prematurely reason  Primary reason participant/subject discontinued study intervention before planned end of study OffStdyIntrvntPrematurRsn Recommended CDE
7 Off study intervention prematurely other text  The free-text field related to 'Off study intervention prematurely reason' specifying other text. Primary reason participant/subject discontinued study intervention before planned end of study OffStdyIntrvntPrematurOTH Recommended CDE

 Change History

 Administrative Change History