Form Structure: Informed Consent and Enrollment
This form structure is an organized set of data definitions for a form that has not been copyrighted
Resource:
FITBIR
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:
General (For all diseases)
Traumatic Brain Injury
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.
Form Administration (Appears 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 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 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 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