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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Traumatic Brain Injury
SubDisease: Comprehensive
Sub-Domain: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Informed Consent
Item count: 2 (2 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C02212
Informed consent obtained date and time
InformConsntObtnDateTime
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.
Date and time of informed consent
  
Date or Date & Time
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).
21 CFR 50.20 General requirements for informed consent A Guide to Informed Consent - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators Contents (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm#general)
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Informed Consent
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Informed consent obtained date and time
 
Free-Form Entry
     
2435038,656
 
C02299
Informed consent type
InformConsntTyp
Type of informed consent obtained
Type of consent
Written informed consent by the participant/subject;Written informed consent by the legal representative on behalf of the participant/subject who gave assent;Written informed consent by the legal representative on behalf of the participant/subject who was unable to give assent;Waiver of consent;
Written informed consent by the participant/subject;Written informed consent by the legal representative on behalf of the participant/subject who gave assent;Written informed consent by the legal representative on behalf of the participant/subject who was unable to give assent;Waiver of consent;
Alphanumeric
Choose one.
21 CFR 50.20 General requirements for informed consent A Guide to Informed Consent - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators Contents (http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm#general)
Adult;Pediatric
Supplemental
3.0
7/20/2013
Aliases for variable name not defined
Informed Consent
Participant/Subject Identification, Eligibility, and Enrollment
Protocol Experience
Informed consent type
 
Single Pre-Defined Value Selected
       
12-14-2018
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