The Most Common and/or Serious Research Audit Findings at IU: What are They? How to Prevent Them?. Christy Yoder, CCRP IUPUI/Clarian Human Subjects Research and HIPAA Auditor. Background.
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Christy Yoder, CCRP
IUPUI/Clarian Human Subjects Research and HIPAA Auditor
Lack of documentation of the consent process
IUPUI/Clarian Research SOP-Obtaining and Documenting Informed Consent
5.7.3, Written notation should also be made in the medical and/or research source record to document that the consent process occurred. Thus for every consent, there should be a corresponding note to file regarding the process.
Not using the ‘current’ version of the informed consent document. (after amendments or continuing reviews)
IUPUI SOP for Obtaining and Documenting Informed Consent
5.10, After the IRB reviews and re-approves the consent document(s), it will be “stamped” with a new approval and continuing review due date. This newly stamped consent document becomes the “current” consent document for the study and must be the version to be signed by all future subjects until such time that a revision to it is approved by the IRB.
Source documentation that is not appropriately signed and dated.
IUPUI SOP for Data Management
188.8.131.52, Case report/data collection forms typically represent the summary or collation of data from the original source documents…While not the original source documents, they may be used as such…and must be signed and dated by the original observer/recorder.
Incorrectly completed “HIPAA Form” or most accurately referred to as the ‘Authorization for the Release of Health Information for Research’ form (the authorization)
Not notifying IUPUI/Clarian RCA of impending audits.
IUPUI SOP for Auditing of Research Involving Human Subjects
5.5.2, When an investigator receives notification of an upcoming compliance inspection visit by a regulatory agency, funding agency, or study sponsor, he/she should immediately notify RCA at …
1. Alerting RCA staff so they can ensure they are prepared to react quickly.
2. Allowing an opportunity for me to assist with preparation, if desired.
Closure of study or lapse in approvals while study related activities are still ongoing.
IUPUI SOP for IRB Operations and Study Approval Process
5.10.9, Oversight by the IRB is required as long as investigators are either interacting or intervening with subjects for research purposes, or accessing identifiable information for research purposes.
Auditing of Research Involving Human Subjects
Children in Research
Collection, Storage, and/or Use of Biological Specimens for Research
Conflict of Interest Reporting to the IRB
Emergency Use of and Planned Emergency Research with Investigational Agents or Devices
Exempt and expedited New Study Approval Process
Handling Humanitarian Use Device
Human Subject Identification, Selection, and Recruitment
Investigational Device Accountability
Investigational Drug Accountability
IRB Operations and Study Approval Process
Obtaining and Documenting Informed Consent
Pregnant Women, Human Fetuses, Neonates, and Fetal Material in Research
Prisoners in Research
Research Personnel Qualifications and Training
Responsibilities of Principal Investigators
Security and Research Data
Subject Confidentiality and Privacy
Unanticipated Problems Involving Risks to Subjects or Others and Noncompliance