Department: Post Approval Monitoring and Education
SOP # 1-6
Revision #3:
TITLE: Documentation of Post
Approved By:
Associate VP for
Research
Approved By:
Research
Compliance
Monitor
Approved By:
Research
Compliance
Monitor
David J. Hudson
Date
7/14/15
Jane Lehmbeck
Date
7/14/15
Elaine Dube
Date
7/14/15
Page: 1 of 2
Approval Monitoring Review
Findings
Date First Effective:
6/15/06
Revision Date:
11/1/06
3/1/09
6/30/15
OBJECTIVE
To define the procedures utilized to prepare a report of findings for each review performed.
RESPONSIBILITY
The Research Compliance Monitors are responsible for preparing PAM reports for each review
performed.
PROCEDURES
1. Prepare the final report utilizing information gathered during the review.
2. Structure of the PAM reports.
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.
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
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
Title: Documentation of Post Approval Monitoring Review Findings
Page 2 of 2
SOP #: 1-6
Recommendations shall be made for findings, as indicated.
 Regulations will be cited to support recommendations, as applicable.
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.
REFERENCES:
FORM Post Approval Monitoring Form 1-6A