FINAL REPORT FORM-MULTICENTER
(To be submitted after ALL subjects have completed their final study visit)
Protocol Number:
Study Sponsor:
Person Completing
Form:
First Name
Last Name
Job Title
Study Title:
Site Information: Please include a cumulative total since the study began.
Please provide information relative to sites approved by Aspire IRB only.
a. Number of sites actively participating in the study:
b. Number of sites that have completed the study:
+
c. Number of sites that have withdrawn or were discontinued from the study:
Attach a listing of withdrawn / discontinued sites and reasons for withdrawals /discontinuations
+
d. TOTAL NUMBER OF SITES THAT HAVE PARTICIPATED IN THIS STUDY
=
Unanticipated Events:
Any unanticipated risk or new information that may alter the risk / benefit ratio must be promptly reported to Aspire IRB to ensure the adequate
protection of the welfare of the research subjects. This includes deviations/violations that fit the following criteria: unexpected (frequency and severity),
increased risk, study related.
1. Did any events considered to be unexpected and related that may alter the risk / benefit ratio occur for this study that have not
been previously reported?
Yes – attach all such unreported events
No
COMPLIANCE STATEMENT
I certify that:
 the information supplied on this form is correct;
 no subjects are currently enrolled or actively being followed in this study
 all protocol mandated collection of identifiable private information about the subjects is complete; and
 all study-related activities are complete.
Authorized Signature
Date
Aspire IRB, Inc.
11491 Woodside Avenue
Santee, CA 92071
619.469.0108 (phone)
619.469.4108 (fax)
Version Date: April 2016