Form Structure: Womack Army Medical Center Enrollment Screening Questionnaire
This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
Womack Army Medical Center Enrollment Screening Questionnaire
Short Name:
WAMCScreeningForm
Description:
Enrollment Screening Questionnaire for all consented study subjects to determine case or control group membership.
Disease:
Traumatic Brain Injury
Organization:
Womack Army Medical Center
Required Program Form:
No
Standardization:
Unique
Labels:
Form Type:
Clinical Assessment
Publication Date:
2017-05-01
Version:
1.0
Date Created:
2017-02-17
Owner:
Number of Data Elements:
35
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 | Context type | The context to which the questions were answered | ContextType | Recommended | CDE |
| 2 | Context type other text | The free-text related to ContextType specifying other text | ContextTypeOTH | Recommended | CDE |
| 3 | Data source | Source of the data provided on the case report form | DataSource | Recommended | CDE |
| 4 | 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 |
Demographics (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Military USA service branch type | Branch of service in the U.S. military, not including the Commissioned Corps | MilUSAServBrnchTyp | Recommended | CDE |
| 2 | Military service status | Status of participant's/subject's military service, not including the Commissioned Corps | MilServStatus | Recommended | CDE |
| 3 | Adult age >18 indicator | Indicator for subject being adult age >18 years | AdultAgeGT18Ind | Recommended | UDE |
Concussion History - Lifetime (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | History of concussion Indicator | Indicator if the subject had a history of concussion | ConcussionHistoryInd | Recommended | CDE |
| 2 | Concussion prior number | Number of prior concussions | ConcussionPriorNum | Recommended | CDE |
Acute (<72 hours) Concussion History (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | TBI Acute Diagnosis Indicator | Indicator of the subject's Acute TBI diagnosis | TBIAcuteDiagnosisInd | Recommended | UDE |
| 2 | Concussion event date | Date (and time, if applicable and known) of concussion event | ConcussionEventDate | Recommended | CDE |
| 3 | Loss of Consciousness (LOC) - from TBI injuries indicator | TBI Screen: Indicator if the subject was or reports being knocked unconscious (not drug over dose (OD) or choked) | TBILocInd | Recommended | UDE |
| 4 | Post traumatic amnesia indicator | Indicator for whether the participant/subject experienced any period of post-traumatic amnesia - both retrograde and anterograde | PstTraumtcAmnsInd | Recommended | CDE |
| 5 | Alteration consciousness indicator | The indicator of whether the participant/subject experienced any period of alteration of consciousness (AOC). | AOCInd | Recommended | CDE |
Concussion History - Last 12 months (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | History of concussion Indicator | Indicator if the subject had a history of concussion | ConcussionHistoryInd | Recommended | CDE |
| 2 |
Injury elapsed time in months
(Retired) |
The elapsed time (in months) from the time of injury | InjElapsedMnthTime | Recommended | UDE |
Visual/Optic History - Exclusion Criteria (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Pre traumatic brain injury seizure or epilepsy indicator | Indicator for seizures or epilepsy that the patient had prior to the traumatic brain injury | PreTBISeizureEpilepsyInd | Recommended | CDE |
| 2 | Nystagmus indicator | Involuntary movements of the eyeballs; its presence or absence is used to diagnose a variety of neurological and visual disorders | NystagmusInd | Recommended | CDE |
| 3 | History Optic Neuritis Indicator | Indicator for whether the subject has a history of optic neuritis | HxOpticNeuritisInd | Recommended | UDE |
| 4 | Blind or serious difficulty seeing indicator | Indicate whether the subject is blind or has serious difficulty seeing, even when wearing glasses | DifficultySeeingInd | Recommended | UDE |
| 5 | History Enucleation Indicator | Indicator for whether the subject has a history of enucleation | HxEnucleationInd | Recommended | UDE |
| 6 | Crossed or wandering eye (amblyopia) indicator | Indicator of if the patient has ever had crossed or wandering eye (amblyopia) | PXCrossEyeOrAmblyopiaInd | Recommended | UDE |
Enrollment (Appears Up To 1 Time)
| # | Title | Short Description | Variable Name | Required? | Type |
|---|---|---|---|---|---|
| 1 | Study eligibility indicator | Indicator of whether the participant/subject is eligible for participation in the clinical research protocol according to its inclusion and exclusion criteria | StdyEligibilityInd | Recommended | CDE |
| 2 | Screening visit ineligibility primary other text | The free-text field related to 'Screening visit ineligibility primary reason' specifying other text. The primary reason identified during a screening visit which makes the potential participant/subject not eligible for a study. | ScreenVisitIneligPrimryOTH | Recommended | CDE |
| 3 | Study subgroup category | Category for the study subgroup that the subject is enrolled in. | StudySubgroupCat | Recommended | UDE |
| 4 | Enrolled in study date and time | Date (and time, if applicable and known) the participant/subject is enrolled into the study | EnrldStdyDateTime | Recommended | CDE |
Keywords
