RECORD OF APPROVED CONSENT FORM VERSIONS INVESTIGATOR STUDY

record of approved consent forms version

INVESTIGATOR:

STUDY SITE:

SPONSOR:

PROTOCOL:

VERSION (per your site’s convention)	IRB APPROVAL/ EXPIRATION DATES	DATE APPROVAL RECV’D. FROM IRB	REASON FOR REVISION*	NECESSARY ACTION**
			NA (Initial approval)	Use for all newly enrolled subjects












* Reasons: - Protocol change ** Actions: - Use for future patients only - New risks identified - Re-consent all active patients - Annual re-approval (text unchanged) - Other - Other

8-9-06

Compliments of:

Site Monitoring, Auditing and Review Team, VA Cooperative Studies Program, Albuquerque, NM