| # | 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 | Visit date | Actual interview or visit date | VisitDate | Recommended | CDE |
| 5 | Vital status | Status of participant/subject as alive or dead | VitStatus | Optional | 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 |
Listed below are your additional element groups.
| # | 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 |
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Patient's global impression of change (PGIC) - scale | Scale of patient's global impression of change, as part of PATIENTS GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE developed by Military Health System | PGICChangeScl | Recommended | CDE |
| 2 | Patient's global impression of change (PGIC) - degree of change scale | Scale of degree of change for patient's global impression of change,as part of PATIENTS GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE developed by Military Health System | PGICDegreeOfChangeScl | Recommended | CDE |
| 3 | Patient's global impression of change (PGIC) - presenting problem text | A free text describing the chief subject complaint or presenting problem, as part of PATIENTS GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE developed by Military Health System | PGICPresentingProblemTxt | Recommended | UDE |