CDE Detailed Report

Disease: content
Subdomain Name: Participant/Subject Identification, Eligibility, and Enrollment
CRF: welcome

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CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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, 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 docume 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 3.00 2013-07-20 10:21:25.65 Informed Consent Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Free-Form Entry

2435038,656
C02299 Informed consent type InformConsntTyp Type of informed consent obtained Type of informed consent obtaine 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

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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 3.00 2013-07-20 10:21:25.65 Informed Consent Participant/Subject Identification, Eligibility, and Enrollment Protocol Experience

Single Pre-Defined Value Selected

CSV