Procedure

Investigator Responsibilities

Responds promptly to requests by the OIRB for arranging audit of the regulatory files;
Provides a quiet area for the records review.
Ensures knowledgeable personnel is available along during the review to answer questions.
Submits a copy of all internal and external monitoring reports within 2 weeks of receipt to the OIRB for review.
Responds in writing to requests by the OIRB monitor, as needed.

OIRB Responsibilities

Management Staff, OIRB Director, and IRB Chair:

Develop a monitoring plan annually.
Select studies for monitoring from a computer-generated random list from the OIRB database as well as according to the following prioritized criteria:
- Investigator-held IND studies;
- Investigator-initiated studies;
- High-risk studies designated by the IRB;
- At the request of the IRB;
- For cause (e.g., participant complaint, non-compliance). If non-compliance is serious or continuing it may be referred to the Compliance Review Subcommittee of the IRB for further investigation (see POL028 policy on, PRO128 procedure for compliance with human subjects regulations or the requirements of the IRB);
- 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; and
- At the request of and in conjunction with the Compliance & Risk Assurance Office.
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.
Reviews regulatory files and verifies:
- 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 being used;
- Original signed informed consent documents appropriately executed;
- Addendum informed consent documents signed, if applicable;
- Adherence to study protocol;
- 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 problems that require prompt reporting to the UAB IRB (see POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB);
- Qualified investigators/study personnel conducting study activities;
- Principal investigator carrying out the agreed upon activities and not delegated them to other staff not previously identified.
Completes monitoring report forms within 2 weeks of audit.
Provides a copy of the monitoring report to the IRB Chair for review prior to distribution and uploads to the study record.
Provides a copy of the completed monitoring report to the principal investigator.
Schedules the monitoring report for the next convened IRB meeting (see PRO145 Procedure for Timing of Document Distribution for Meetings).
Generates quarterly cumulative protocol monitoring.
Issues the letter of IRB determination and action to the investigator and study personnel.

IRB Responsibilities

Reviews monitoring reports at a convened meeting and takes action as indicated.