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.
Registration Status:
Qualified
Permissible Values:
Data Type:
Date
Unit of Measure:
Ids:
Value
Code Name
Code
Code System
Code Description
Designations:
Designation:
Informed consent obtained date and time
Tags:
Designation:
Informed Consent Obtained Date and Time
Tags:
Designation:
Informed Consent Date/Time
Tags:
Suggested Question Text
Designations:
Definition:
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.
Tags:
Reference Documents:
ID:
Title:
URI:
Provider Org:
Language Code:
Document:
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)