MonitoringMonitoring

IRB Monitoring of Clinical IRB Monitoring of Clinical TrialsTrials

Types of MonitoringTypes of Monitoring

InternallyInternally ExternallyExternally

Which Protocols are Monitored?Which Protocols are Monitored?

All protocols reviewed by the IRB are All protocols reviewed by the IRB are subject to regulatory monitoring by subject to regulatory monitoring by IRB personnel;IRB personnel;

A random list is generated yearly by A random list is generated yearly by the IRB Information Systems the IRB Information Systems Specialist of active protocols for Specialist of active protocols for monitoring;monitoring;

In addition, protocols are monitored In addition, protocols are monitored for-cause.for-cause.

Types of Studies SelectedTypes of Studies Selected Investigator-initiated studies;Investigator-initiated studies; Investigator-held IND/IDE studies;Investigator-held IND/IDE studies; High-risk studies designated by the IRB;High-risk studies designated by the IRB; At the request of the IRB;At the request of the IRB; For cause;For cause; Studies conducted by investigators with prior 483 Studies conducted by investigators with prior 483

Inspectional Observations or warning letters from Inspectional Observations or warning letters from the FDA;the FDA;

Studies with a large number of SAEs or protocol Studies with a large number of SAEs or protocol deviations reported;deviations reported;

High enrollment studies;High enrollment studies; Outside monitoring reports from sponsors received Outside monitoring reports from sponsors received

by the OIRB indicating deficiencies;by the OIRB indicating deficiencies; At the request of and in conjunction with the UAB At the request of and in conjunction with the UAB

Research Compliance Office.Research Compliance Office.

Investigator ResponsibilitiesInvestigator Responsibilities Responds promptly to requests by the OIRB Responds promptly to requests by the OIRB

for arranging audit of the regulatory files;for arranging audit of the regulatory files; Provides a quiet area for the records review;Provides a quiet area for the records review; Is available, along with study coordinator, Is available, along with study coordinator,

during the review to answer questions;during the review to answer questions; Responds promptly, in writing, to requests by Responds promptly, in writing, to requests by

the OIRB monitor;the OIRB monitor; Submits a corrective action plan, in writing, Submits a corrective action plan, in writing,

within 30 days, if requested.within 30 days, if requested.

OIRB Monitor ResponsibilitiesOIRB Monitor Responsibilities

Schedules appointment for regulatory Schedules appointment for regulatory monitoring with the investigator and study monitoring with the investigator and study coordinator usually 2 to 4 days in advance coordinator usually 2 to 4 days in advance of visit;of visit;

Sends follow-up written communication Sends follow-up written communication confirming appointment and list of pertinent confirming appointment and list of pertinent study materials that should be available for study materials that should be available for the reviewer as well as any issues that need the reviewer as well as any issues that need to be specifically addressed;to be specifically addressed;

Meets with the study coordinator and Meets with the study coordinator and principal investigator, if needed;principal investigator, if needed;

OIRB Monitor ResponsibilitiesOIRB Monitor Responsibilities

Completes monitoring report forms Completes monitoring report forms within 2 weeks of audit;within 2 weeks of audit;

Sends copy of the report to the PI;Sends copy of the report to the PI; Schedules the report for the next Schedules the report for the next

convened IRB meeting;convened IRB meeting; Re-audits in 6 months if audit reveals Re-audits in 6 months if audit reveals

deficiencies that are unacceptable.deficiencies that are unacceptable.

What is Reviewed and Verified?What is Reviewed and Verified?

Study protocol approved;Study protocol approved; Continuing reviews submitted prior to expiration of Continuing reviews submitted prior to expiration of

approval;approval; Screening and enrollment logs accurate and up to Screening and enrollment logs accurate and up to

date;date; IRB approval obtained prior to participant IRB approval obtained prior to participant

enrollment;enrollment; Valid informed consent documents were used;Valid informed consent documents were used; Original signed informed consent documents Original signed informed consent documents

appropriately executed;appropriately executed; Addendum informed consent documents signed, if Addendum informed consent documents signed, if

applicable;applicable; Adherence to study protocol;Adherence to study protocol;

Modifications to the protocol and informed Modifications to the protocol and informed consent document submitted to the IRB and consent document submitted to the IRB and approved prior to initiation;approved prior to initiation;

Accurate, complete and current records being Accurate, complete and current records being maintained;maintained;

Timely, accurate, and complete reporting of Timely, accurate, and complete reporting of serious adverse events and protocol deviations to serious adverse events and protocol deviations to the sponsor and the UAB IRB;the sponsor and the UAB IRB;

Qualified investigators/study personnel Qualified investigators/study personnel conducting study activities;conducting study activities;

Principal investigator carrying out the agreed Principal investigator carrying out the agreed upon activities and not delegating them to other upon activities and not delegating them to other staff not previously identified;staff not previously identified;

Records maintained appropriately.Records maintained appropriately.

What is Reviewed and Verified?What is Reviewed and Verified?

IRB ResponsibilitiesIRB Responsibilities

Reviews monitoring reports at a Reviews monitoring reports at a convened meeting;convened meeting;

Makes a determination to accept the Makes a determination to accept the report;report;

Takes action, if indicated and Takes action, if indicated and determined to be necessary, based determined to be necessary, based on the report.on the report.

Questions?Questions?