informed consent/demographics

Site

Patient Number

Please enter in three digit format (e.g., 001, 002, ..., 025)

Is this an original or revised submission?

Original

Revised

Name of the Person Entering Data into this CRF

First Name

Last Name

THE ANSWER TO #1 MUST BE "YES"

Has the subject been properly informed about the study per 21 CFR 50.20 and signed the current IRB-approved informed consent form?

Yes

Date of Informed Consent

YYYY

Time of Informed Consent (Set Seconds to "00")

Hour

Minute

Second

ICF Version:

Patient Race

If Patient Race is "other", please specify:

Subject Date of Birth

YYYY

Attestation

I approve the data entered into this CRF and attest to its accuracy.

Date of Completion

YYYY