Department: Post Approval Monitoring and Education
SOP # 1-1
Revision #3:
Approved By:
Associate VP for
Research
Approved By:
Research
Compliance
Monitor
Approved By
Research
Compliance
Monitor
TITLE: Protocol Selection
Page: 1 of 1
David J. Hudson
Date
7/14/15
Jane Lehmbeck
Date
7/14/15
Elaine Dube
Date
7/14/15
Date First Effective:
6/15/06
Revision Date:
11/01/06
3/1/09
8/10/2011
6/30/15
OBJECTIVE
To define the procedures utilized to select protocols for the purpose of post-approval monitoring review.
RESPONSIBILITY
The Research Compliance Monitors will be responsible for the implementation of Post Approval
Monitoring review.
PROCEDURES
1. Identify protocols for post-approval monitoring (PAM) review through random selection utilizing
the IRB database. Protocols must meet the following criteria:


have an “active open to enrollment” or “closed to enrollment/subjects being treated”
approval status;
have had a full committee or expedited review
2. Additionally, post-approval monitoring reviews may be initiated when one or more of the
following occur:





Request by study team members of an IRB-HSR approved protocol, IRB-HSR staff, research
subject or other sources where compliance concerns have been raised; research approval
expires due to failure by the investigator to submit continuation status report and PI is
requesting the study to be re-opened;
research where paperwork submitted to the IRB-HSR was felt to be inadequate;
studies monitored by the Cancer Center DSMC under their institutional Data Safety Plan;
for any change in PI after initial study approval and study remains open to enrollment;
Request by study team as an educational tool.
3. Conduct random post-approval monitoring reviews no more frequently than once every two years
for investigators receiving a category 1 rating, unless an audit is required or requested as noted
above.
REFERENCES:
None