Informed Consent/HIPAA Authorized Obtained
Document(s) signed
Document(s) signed
text
Version Date
date
Approval Date
date
Expiration Date
date
undefined itemgroup
Consent Form, and related study documents, was thoroughly reviewed with the subject.
boolean
Subject had sufficient time to review the documents and ask questions.
boolean
Informed consent/HIPAA Authorization obtained prior to any study related procedures.
boolean
A copy of the signed documents have been given to the subject.
boolean
Name of the person that obtained consent
text
Comments
text
Informed Consent Refused
Time
time
Not Applicable
boolean
This form should be completed for each Informed Consent process (i.e. if Re-consented)
text