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					       Monitoring
IRB Monitoring of Clinical Trials
         Types of Monitoring
   Internally
   Externally
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.
       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.
     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.
    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;
    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.
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;
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.
          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.
Questions?

				
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posted:8/25/2012
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