Monitoring

1
Monitoring

• IRB Monitoring of Clinical Trials

2
Types of Monitoring

• Internally
• Externally

3
Which Protocols are Monitored?

• All protocols reviewed by the IRB are subject to
  regulatory monitoring by IRB personnel
• A random list is generated yearly by the IRB
  Information Systems Specialist of active
  protocols for monitoring
• In addition, protocols are monitored for-cause.

4
Types of Studies Selected

• Investigator-initiated studies
• Investigator-held IND/IDE studies
• High-risk studies designated by the IRB
• At the request of the IRB
• For cause
• Studies conducted by investigators with prior 483
  Inspectional Observations or warning letters from
  the FDA
• Studies with a large number of SAEs or protocol
  deviations reported
• High enrollment studies
• Outside monitoring reports from sponsors received
  by the OIRB indicating deficiencies
• At the request of and in conjunction with the UAB
  Research Compliance Office.

5
Investigator Responsibilities

• Responds promptly to requests by the OIRB for
  arranging audit of the regulatory files
• Provides a quiet area for the records review
• Is available, along with study coordinator,
  during the review to answer questions
• Responds promptly, in writing, to requests by the
  OIRB monitor
• Submits a corrective action plan, in writing,
  within 30 days, if requested.

6
OIRB Monitor Responsibilities

• Schedules appointment for regulatory monitoring
  with the investigator and study coordinator
  usually 2 to 4 days in advance of visit
• Sends follow-up written communication confirming
  appointment and list of pertinent study materials
  that should be available for the reviewer as well
  as any issues that need to be specifically
  addressed
• Meets with the study coordinator and principal
  investigator, if needed

7
OIRB Monitor Responsibilities

• Completes monitoring report forms within 2 weeks
  of audit
• Sends copy of the report to the PI
• Schedules the report for the next convened IRB
  meeting
• Re-audits in 6 months if audit reveals
  deficiencies that are unacceptable.

8
What is Reviewed and Verified?

• Study protocol approved
• Continuing reviews submitted prior to expiration
  of approval
• Screening and enrollment logs accurate and up to
  date
• IRB approval obtained prior to participant
  enrollment
• Valid informed consent documents were used
• Original signed informed consent documents
  appropriately executed
• Addendum informed consent documents signed, if
  applicable
• Adherence to study protocol

9
What is Reviewed and Verified?

• Modifications to the protocol and informed
  consent document submitted to the IRB and
  approved prior to initiation
• Accurate, complete and current records being
  maintained
• Timely, accurate, and complete reporting of
  serious adverse events and protocol deviations to
  the sponsor and the UAB IRB
• Qualified investigators/study personnel
  conducting study activities
• Principal investigator carrying out the agreed
  upon activities and not delegating them to other
  staff not previously identified
• Records maintained appropriately.

10
IRB Responsibilities

• Reviews monitoring reports at a convened meeting
• Makes a determination to accept the report
• Takes action, if indicated and determined to be
  necessary, based on the report.

11
Questions?