CDE Detailed Report
Disease: Traumatic Brain Injury
Subdomain Name: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Informed Consent
Displaying 1 - 2 of 2
Subdomain Name: Participant/Subject Identification, Eligibility, and Enrollment
CRF: Informed Consent
Displaying 1 - 2 of 2
| 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 |
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 | 3.00 | 2013-07-20 10:21:25.65 | Informed Consent | Participant/Subject Identification, Eligibility, and Enrollment | Protocol Experience |
Single Pre-Defined Value Selected |
