2003D-0204 - Guidance for Industry: Institutional Review Board Review of Stand-Alone Health Insurance Portability and Accountability Act Authorizations; Availability
FDA Comment Number : EC1
Submitter : Mr. Norman Goldfarb Date & Time: 06/10/2004 05:06:32
Organization : First Clinical Research, Inc.
Drug Industry
Category :
Issue Areas/Comments
When a CE contacts its patient by telephone about his/her interest in participating in a clinical trial, it should be acceptable for the CE to document the patient's answer in a log or progress note, perhaps with a follow-up confirmation letter from the CE to the patient. It should be acceptable for the CE to contract with a third-party, e.g., a physician, consultant or SMO, with the patient's verbal consent, to explain the study in more detail to the patient, and, if appropriate, to do preliminary prescreening and schedule an initial visit at the CE.

The current requirement, for a signed authorization from the patient, before such a hand-off, causes a very high failure rate in obtaining authorization.

This process could be covered by the CE's normal HIPAA authorization form.