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Common Data Element:  Informed consent obtained date and time

Listed below are the details for the data element.

1.4
Element Type
Common Data Element
Informed consent obtained date and time
InformConsntObtnDateTime
Short Description
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.
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.
 

Biomedical Terminologies and Standards

Notes
cdRNS|FITBIR|PDBP;
Creation Date
Historical Notes
Informed consent obtained date and time
References
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)

Data Type
Date or Date & Time
Input Restrictions
Free-Form Entry
External Schema Permissible Value Mapping
Population
Adult and Pediatric
Guidelines/Instructions
GENERAL: Record the date(and time) the informed consent form is signed. 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.) and in the format acceptable to the study database. TBI: 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.). Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.
Preferred Question Text
Date and time of informed consent
Category Groups and Classifications
DiseaseDomainSub-Domain
Traumatic Brain Injury Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment
General (For all diseases) Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Classification

General (For all diseases) :
Core
Acute Hospitalized :
Supplemental
Epidemiology :
Supplemental
Moderate/Severe TBI: Rehabilitation :
Supplemental
Concussion/Mild TBI :
Supplemental
Keywords
Labels
NINDS_CDE
Effective Date
Until Date
Last Change Date
Fri Aug 11 15:00:31 EDT 2023
See Also
Submitting Organization Name
NIH/NINDS
Submitting Contact Name
NINDSCDE
Submitting Contact Information
NINDSCDE@emmes.com
Steward Organization Name
NIH/NINDS
Steward Contact Name
NINDSCDE
Steward Contact Information
NINDSCDE@emmes.com
NINDS ID

Change History