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1-7B.2.b VPR letter –marginal July 11, 2017 Dear Dr. XXXXXX, I would like to thank you for your cooperation in the recent post approval monitoring (PAM) review of your clinical research protocol entitled, HSR # xxxxx – “ ” completed on xx-xx-xx. Members of the PAM Working Group and the IRB PAM Advisory Committee have had an opportunity to review the PAM report (and your response if applicable) and agree with the recommendations made in the report. Please make any corrective actions requested in a timely manner. Additionally, the Committee requests the following: If you have any questions about the findings and recommendations of your post-approval monitoring, please contact our office. Sincerely, David J. Hudson, PhD Associate Vice President Phone: 434-243-0900 Email: [email protected] Cc: Post Approval Monitors Department Chair Study Coordinator IRB-HSR Administrator or IRB of record Chair, IRB-HSR (if IRB-HSR is IRB of record) SOM CTO Educator Cancer Center DSMC (if needed)