Form Structure: End of Study Disposition
This form structure is an organized set of data definitions for a form that has not been copyrighted
Resource:
FITBIR
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
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 |
Keywords
