research compliance auditing
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RESEARCH COMPLIANCE AUDITING. UTHSC IRB Donna Hollaway , RN, CCRC 11/30/2011. Authority to Audit. 45 CFR 46.109(e) - PowerPoint PPT PresentationTRANSCRIPT
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RESEARCH COMPLIANCE AUDITING
UTHSC IRB
Donna Hollaway, RN, CCRC11/30/2011
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Authority to Audit45 CFR 46.109(e)An IRB shall conduct continuing review of
research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
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UTHSC Local IRB PolicyThe process of compliance auditing is meant to
accomplish several important purposes:Assure human subjects are properly
protected, and that procedures to accomplish this goal are carefully documented
Assist investigators in complying with current regulatory standards for protecting human subjects and in avoiding any external sanctions that may result from non-compliance with standard of practice
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Local Policy (cont)Process is intended to assure that the
University and affiliated institutions remain in good standing with federal agencies having oversight of human subject research activities.
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Most frequently asked question:
“How did my study get
selected for a compliance
audit?”
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TYPES OF AUDITSObservation of the informed consent
interviewFor causeRandom
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What is reviewed during an audit?
Informed consent documentsSubject eligibility documentationVerification of the informed consent interviewResearch recordsMedical records (if required)DatabaseStudy medication ConfidentialityRegulatory documents
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“Informed consent is the cornerstone of human subject research and the critical element in assuring the protection of subjects who voluntarily choose to enroll in a study.”
Research Practitioner
July-August 2011
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Informed ConsentCorrect version (most current)IRB-stamped versionPages initialed by subjectOnly designated personnel
conducted the informed consent interview
Signatures dated and timed by signatories:
Subject Person Obtaining Consent Investigator (must sign with 72
hours)
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Informed Consent Verification21 CFR 312.62(b), “the case history for each individual shall document that informed consent was obtained prior to participation in the study”. Generally, industry fulfills this requirement in one of two ways:
• By documenting consents in source documents; or
• By documenting consents on case report forms.
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Best practices call for a contextual statement in a source document regarding exactly how and when the consenting processing occurred.
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Subject Eligibility
There must be some type of documentation that the subject strictly meets the inclusion/exclusion criteria
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Research Records
Research records will be reviewed for completeness, timeliness, and accuracy
Were visits and study procedures completed within the defined window?
Can data be verified from a source?
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Protocol DeviationsDeviations: Failure to follow procedures
specified in the approved research protocol in the absence of a protocol waiverMinor – no substantive effect on the risks or
benefits for the subject, and no effect on value of data, and does not result from willing or knowing misconduct on the investigator or study staff
Major – deviation that has harmed or posed significant risk of harm to subject, or compromised scientific integrity of data, or appears to result from misconduct
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Medical Records
If the study involves the subject’s clinical record, the records will be compared to data points in the research record for compatibility.
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Database
If the data has been entered into a database, the database will be reviewed for accuracy, security, and accessibility.
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Study Medication
Is it being stored according to the protocol?Are the dispensing records up to date?Is returned study medication stored
correctly?Is it being stored securely, who has access to
it?
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Confidentiality
• Where are the study records stored?• Who has access to the records?• How are the records labeled?• Has a database been created?• How are specimens labeled?• Is any portion of the specimen retained at the
local site?
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Regulatory Documents
Regulatory documents are reviewed for continuity, changes in study procedures, amendments/changes that should be submitted to the IRB, study staff responsibilities/assignments, study staff training, investigator CVs, and evidence of PI oversight.
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What happens after the audit?Audit report is written and forwarded to the
IRB chairmanFollow-up letter is written documenting audit
findingsPI and key study staff receive copies of audit
report and letter via iMedRISAudit report and letter is placed in “Other
Documents” in iMedRIS (as well as “Correspondence”)
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How to respond to an auditIf there are no significant audit findings, no
response is necessaryIf audit findings require a revision to the
study application, a Form 2 will be requestedIf audit findings require corrective action,
items to be addressed will be outlined in the letter
A correspondence can be created in iMedRIS to address each request for corrective action or additional information