Investigator Signature Only the PI Can Sign Date

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SITE FINAL Fax: REPORT FORM (866)Fax: 872-(866) This form is to be 0526872- submitted only if all subject Website:0526 participation is complete, no study w wWebsite: w .irbco.com activity is being conducted, no w w w .irbco.com analysis of data from this site remains, and no private identifiable health Email: information is being collected. Note: irb@irbcEmail: Selecting this o.comirb@irbc option will terminate o.com your IRB approval. No study- related activity may occur without IRB approval.

Principal Investigator (PI): IRB No.: Protocol No.:

Study Title:

Sponsor: Expiration Date:

1. Number of subjects enrolled since the beginning of the study.

2. Number of subjects completed. 3. Please provide a summary of the withdrawals from the research (both subject and investigator initiated) since the beginning of the study. Include the number and reasons for withdrawal.

4. Number of subjects lost to follow-up since the beginning of the study.

5. Subject Transfers:

5a. Number of subjects who have transferred in since the beginning of the study

5b. Number of subjects who have transferred out since the beginning of the study.

6. Please provide a summary, including the number, of serious adverse events or unanticipated problems, particularly risks to subjects and/or others that have occurred since the beginning of the study.

of 2 [Version 03.01.2013] 7. Please provide any relevant multicenter trial reports (serious adverse event reports, Data Monitoring Committee reports or other reports) that have not been previously submitted through a report form.

8. Please provide a summary of any complaints from the subjects about the research since the beginning of the study.

9. Please provide a summary of any findings, literature, or other relevant information you learned through the study.

By signing, I certify under penalty of perjury that the information entered on this document is true and correct.

______Investigator Printed Name

______Investigator Signature – Only the PI can sign Date

of 2 [Version 03.01.2013]