Final Review Report

FINAL REVIEW REPORT

Investigator: Date submitted: Site:

Address: Asentral #:

Sponsor:

Protocol Number:

1. Are any subjects still participating in this trial? Yes No If No, please check all reasons that apply below.

Study closed No subjects were enrolled Investigator withdrawn Study placed on hold Other please explain

2. Date Study Closed by the Sponsor at this site: (mm/dd/yy)

Number of Subjects Primary Trial Trial Extension (if applicable) A Subjects Consented

B Screen failures (signed the consent form, but later proved not to qualify for the study during screening procedures) C Subject withdrawals/terminations (consented but later withdrew or were terminated after enrollment/randomization); include any deaths. See #4 below. D Subjects Completed

NOTE: D = A-B-C

3. At your site, have there been any deaths, hospitalizations, or other Serious Adverse Events (whether or not they are deemed drug related) not previously reported to Asentral IRB?

Yes No (If yes, attach a copy of the SAE report).

Version: July 19, 2016 4. At your site, have there been any subjects since the last Annual Report who have withdrawn or been terminated (do not include screen failures) from the study after they begin study procedures (as listed in table above in row C)? If yes, attach a brief of each affected subject’s circumstances:

5. Comments about the study, including outcome results of the study (if known):

6. Has any new information involving risks or benefits to subjects become available from the sponsor that has not been previously reported to Asentral IRB? Yes No (If yes, attach a copy)

7. Please briefly describe how you intend to safely store the confidential study subject records and information collected during this study.

Where? For how long? Who will have access?

Signature: ______Date: ______Principal Investigator or Designee

Printed: ______Principal Investigator or Designee

IMPORTANT: Please attach a copy of the informed consent form(s) used to consent the most recently consented subject in the study (with the subject’s name blackened out, but not the initials or any dates).

Please submit this report and the redacted ICF to Asentral, Inc. IRB as soon as possible after the date of this study being closed by the sponsor.

If you do not plan to formally close this study before the expiration date of the Annual IRB approval date (found on your initial approval letter or previous Annual Review Approval Letter) you must submit an Annual Review Report and supporting documents at least two weeks prior to the expiration date of the IRB’s approval of this study.

Please submit the complete package via USPS, courier, or scan and email to [email protected].

PLEASE NOTE THAT ASENTRAL. INC. CANNOT PROCESS FINAL REVIEW REPORTS WITHOUT THIS INFORMATION.

Version: July 19, 2016