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 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:
1.1
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
ESD
