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Form Structure: Informed Consent and Enrollment

This form structure is an organized set of data definitions for a form that has not been copyrighted
Title:
Informed Consent and Enrollment
Short Name:
InformedConsEnroll
Description:
The form structure is created based on NINDS recommended CDEs for collection of informed consent, enrollment and randomization. References: https://commondataelements.ninds.nih.gov/TBI.aspx#tab=Data_Standards
Disease:
Traumatic Brain Injury General (For all diseases)
Organization:
NINDS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2017-05-24
Version:
1.0
Date Created:
2017-01-24
Owner:
Number of Data Elements:
21
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.

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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

Informed Consent (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Informed consent obtained indicator  Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study InfConsntObtInd Recommended CDE
2 Informed consent obtained date and time  Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. InformConsntObtnDateTime Recommended CDE

Enrollment (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Enrolled in study indicator  Indicator of whether the participant/subject was enrolled into the clinical research study. EnrldStdyInd Recommended CDE
2 Enrolled in study date and time  Date (and time, if applicable and known) the participant/subject is enrolled into the study EnrldStdyDateTime Recommended CDE

Randomization (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Randomized indicator  Indicator of whether the participant/subject was randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group RandomizedInd Optional CDE
2 Randomized date and time  Date (and time, if applicable and known) the participant/subject is randomly assigned (i.e., by chance not choice) to an intervention/treatment group or control group. RandomizedDateTime Optional CDE
Keywords

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