<p> Department: Post Approval Monitoring and Education SOP # 1-6 TITLE: Documentation of Post Page: 1 of 2 Revision #3: Approval Monitoring Review Findings Approved By: David J. Hudson Date Date First Effective: Associate VP for 7/14/15 6/15/06 Research Approved By: Jane Lehmbeck Date Research 7/14/15 Compliance Monitor Approved By: Elaine Dube Date Revision Date: Research 7/14/15 11/1/06 Compliance 3/1/09 Monitor 6/30/15</p><p>OBJECTIVE To define the procedures utilized to prepare a report of findings for each review performed.</p><p>RESPONSIBILITY The Research Compliance Monitors are responsible for preparing PAM reports for each review performed. </p><p>PROCEDURES</p><p>1. Prepare the final report utilizing information gathered during the review. </p><p>2. Structure of the PAM reports.</p><p>The heading of the PAM report should include the following information:  The IRB-HSR number and the title of the research study;  The name of the principal investigator;  The name of the research coordinator;  The date(s) on which the audit was conducted.</p><p>The introduction of the PAM report should include but not be limited to the following:  A brief summary of the research study;  Source of funding;  The number of subjects approved and currently enrolled in the study;  The number of research records reviewed.  Dates of initial and most recent IRB approvals. Information regarding IRB of record if not UVA IRB-HSR</p><p>The body of the PAM report should include the following summaries:  IRB approvals and correspondence;  Informed consent documentation;  Subject selection criteria;  Documentation of study procedures and verification of protocol compliance;  Recording/reporting of adverse events and data safety monitoring plan compliance;  Study drug documentation and accountability, if applicable. Department: Post Approval Monitoring Page 2 of 2 Title: Documentation of Post Approval Monitoring Review Findings SOP #: 1-6</p><p>Recommendations shall be made for findings, as indicated.  Regulations will be cited to support recommendations, as applicable.</p><p>The general comment section reflects the Research Compliance Monitor’s overall assessment of the findings and the study team’s response. An initial education and follow-up recommendation is made by the Research Compliance Monitor based on the number and severity of deviations found.</p><p>REFERENCES: FORM Post Approval Monitoring Form 1-6A</p>