CPHS has the authority to request for random or ‘for cause’ study reviews of protocols under its oversight. The study review may include review of CPHS processes and documentation, study site documentation, observation of consent process and research.
Triggering a for cause audit - CPHS may request for a for cause audit at anytime, including after the research is closed. Factors that may cause the CPHS in determining whether to go forward with an audit include, but are not limited to:
§ Research involving vulnerable populations;
§ Research involving recombinant DNA or gene transfer;
§ Research conducted internationally;
§ Use of waiver or alteration of informed consent procedures;
§ Research for which subjects would be exposed to additional risks (e.g. breach of confidentiality, Phase 1 studies);
§ Previous suspension of the research due to compliance issues; and
§ Recommendations from other institutional committees (chemical safety committee, biosafety committee);
§ Research is suspended or terminated;
§ Research has non-compliance issues;
§ Unanticipated problems involving risks to subjects or others for the research have been reported to the DSRB;
§ Other situations where the DSRB has concerns that warrants an audit.
The Clinical Research Monitor shall conduct for cause and random audits, including observation of consent process. In certain situations, CPHS may request an external auditor to conduct an audit. Besides for cause audits, the Clinical Research Monitor shall conduct regular random audits. The Monitor will select a representative sample of active protocols of greater than minimal risk.
The Monitor will inform the Principal Investigator at least a week in advance of the upcoming review and set up an agreeable time for the review. The Principal Investigator be available for questions, have documents accessible, and respond to any written requests within the time frame agreed with the Monitor.
The monitoring shall include, but not be limited to:
§ Auditing advertisements and other recruiting material and practices;
§ Recruitment procedures;
§ Informed consent documentation and, if applicable, observation of the process;
§ If deemed necessary, observation of research interactions or interventions with research participants;
§ Verification from sources other than the PI that no unapproved changes have occurred since the previous review;
§ Storage and use of investigational drugs and devices;
§ All serious and unanticipated events have been reported to the CPHS as per Policy and Procedure Unanticipated Problems; and
§ Other activities as deemed appropriate for a particular study.
The Monitor will communicate preliminary findings to the Principal Investigator to facilitate understanding of the process and collaboration in resolving any outstanding issues/concerns at an exit interview that will occur after each compliance review.
The Monitor will submit a report to the Principal Investigator. The PI will address and respond to the recommendation(s) suggested by the Clinical Research Monitor within a timely manner. The Clinical Research Monitor will give a report to the CPHS at a convened meeting.
CPHS Review: The Monitor will submit a copy of the report to the CPHS. The CPHS will review this at a convened meeting.
Review Outcome: Should the Clinical Research Monitor discover an issue that potentially places participants at risk he/she will report the findings immediately to the ORSC Director, the Chairperson of the IRB responsible for the study and the Executive Chairperson. The Clinical Research Monitor shall provide detailed information that supports this determination.
The Chairperson shall review the study and determine if the study should be placed on “Administrative Hold”, designating the specific reason for the hold. If it is placed on “Administrative Hold” the CPHS will be notified at the next convened meeting as per policy and procedure Suspension and Termination of CPHS Approval.
The CPHS may accept the audit report with or without revisions to the currently approved study or impose additional measures; these may include, but are not limited to:
§ Request status reports after each participant receives intervention;
§ Decrease the continuing review cycle (e.g. 3 months, 6 months, after a specific number of participants are enrolled);
§ Require an independent safety monitor or formation of a DSMB to monitor activities locally, or nationally if UTHSC-H is a coordinating center;
§ Request an off-cycle DSMB review and written report;
§ Conduct a follow-up audit by the Clinical Research Monitor;
§ Limit Investigator’s ability to submit new research studies to the CPHS; and/or
§ Require a research intermediary to participate in or monitor the informed consent process.
Education: Create an education plan which may include, but not be limited to:
§ One-on-one instruction with a person to be determined by the CPHS responsible for the study;
§ Attendance of PI and/or research staff at local, regional or national conferences on human subjects protections;
§ Review of additional regulatory documents or materials (e.g. Belmont Report, 45 CFR 46, CPHS policies and procedures, OHRP determination letters)
§ Additional web-based human subjects protection training (e.g. OHRP, NIH, NCI); and/or
§ Completion of additional pertinent CITI modules.
Research Intermediary: CPHS may require the research intermediary to observe the consent process, in situations including, but not limited to:
§ Research involving high risks to subjects;
§ Particularly complicated procedures or interventions;
§ Potentially vulnerable populations;
§ Study staff with minimal experience in administering consent to potential subjects; or
§ Other situations where CPHS has concerns that consent process might not be proceeding well.
REFERENCES TO OTHER SOP
1. Monitoring Checklist
2. Monitoring Report Template
If you find errors in this document, contact firstname.lastname@example.org
1 Jan 2009
1 Aug 2011