Internal “For Cause” or “Directed” Audit Process and Site Preparation |
A single protocol, or all protocols currently being conducted by an investigator may be selected either by an IRB, or by the Vice Dean for Clinical Investigation, for a “for cause” or “directed” audit. These audits may be done for a variety of reasons. During an audit, all regulatory and subject records are reviewed, and most, if not all, members of the compliance team are present to complete the audit. Before the Audit: In preparation for an audit, you should review your regulatory information (IRB, FDA, any funding source, if applicable, SOPs), and make sure that you have all information complete and in a logical order. Subject binders should also be reviewed. This review should include: identifying a location where records may be reviewed, assuring there is a complete, original signed consent form for each enrolled subject; documentation of the consent process (if available); documentation of eligibility; source documentation is available to verify eligibility; source documentation (including medical records, which may need to be ordered, if the subject was an inpatient) for verification of the completion of protocol tasks; and reports of all unexpected problems involving risk to subjects. During the Visit: The monitors will meet briefly with the PI and study staff at the beginning of the audit to introduce themselves and explain the process. Records will be review at the location identified by the study team. Once the monitors have completed the review of the records, they will meet with the study staff and PI (if available). They will review any preliminary findings or recommendations, or ask for any clarifications needed to complete the review. After the Audit: Following the audit, the monitors will write up a report, which will be sent to the PI and study staff. The PI will have a chance to respond to the report. The report will then be sent for review by the IRB and the Vice Dean for Clinical Investigation.
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