Informed Consent Process

A Consent Form is provided by the sponsor

with the study protocol or created by the site investigator.

The Consent Form is personalized by each site, 1 Source documents must reflect
adding local contact names and numbers. that consent was obtained before
the start of study treatment and
procedures.

The Consent Form is approved for use 2 A copy of the signed consent form
by the Institutional Review Board. must be kept at the site.

3 All versions of approved consent

forms must be kept in the site
study file; only the current IRB
Investigator or designated study personnel informs the patient
approved version may be used to
about the study purpose, risks, and potential benefits.
consent new patients.

The patient is allowed time to read the Consent Form,

ask questions, and consider participation.

The patient or legal representative signs and dates* the Consent Form.
The sponsor and/or IRB may require additional signatures.

The patient is given a copy of the Consent Form

and study treatment and procedures can be started.

*Date not required for Title 45 trials

Informed Consent is an ongoing process.

The patient should be provided with information throughout the study that might influence the patient’s decision to continue participation.