Ohio Administrative Code › Title 3364 - University of Toledo › Chapter 3364-70 - Research Protection and Practices › Section 3364-70-28 - Internal auditing of clinical research policy

Current through all regulations passed and filed through July 1, 2024
(A)
								Policy
			 statement
All clinical trials conducted at the
				university of Toledo ("university") are subject to internal audit inspections,
				including those trials sponsored by pharmaceutical and/or device companies,
				national institute of health ("NIH"), other sponsors, and those that are
				investigator-initiated. The jacobson center for clinical and translational
				research ("JCCTR") is responsible for conducting and overseeing the internal
				audit compliance program.
(B)
								Purpose of
			 policy
The primary purpose of the internal
				audit process is to ensure the protection of human subjects, verify the
				validity and accuracy of data collection, identify noncompliance, and take
				corrective action when necessary. The audit process involves verifying subject
				eligibility, protocol adherence, and regulatory compliance according to federal
				drug administration ("FDA"), international conference on harmonization ("ICH")
				good clinical practice, university policies, and all other applicable
				regulations. The internal auditing of clinical trials will promote continuous
				improvement opportunities by providing an increased awareness of university
				policies to researchers and staff as well as education of best practices to
				ensure the university is conducting consistent high quality
				research.
(C)
								Scope
Internal audits will be categorized as:
				targeted, for-cause, and informal audits that are performed to assist in
				preparations for a scheduled or anticipated inspection by the FDA or sponsor.
				Targeted audits are routine and selection is based on prioritized set criteria
				(see (D)(1) of this rule) which includes those with an increased likelihood for
				an external audit (e.g. high enrollment) or a specific category of research
				such as gene transfer research. For-cause audits can be initiated at the
				request of the institutional review board ("IRB"), research administration, or
				some other group or person who has raised substantive concerns regarding study
				conduct. Informal audits can be requested by the principal investigator ("PI")
				or research staff and is dependent upon current work flows and resource
				availability and schedules.
(D)
								Targeted internal
			 audit procedures
(1)
									The internal audit process begins with selecting a
			 study protocol to audit. Set criteria are used to prioritize all active
			 clinical research studies: new investigators and/or research coordinators,
			 number of subjects enrolled, sponsorship, disease site, and
			 complexity/high-risk studies.
(2)
									The clinical
			 research auditor will coordinate all internal audits.
The PI and research staff will be sent
				a notification letter via email that contains the following:
(a)
										The study
			 title/protocol that will be audited.
(b)
										The agreed dates
			 the auditor will be on site.
(c)
										That all subject
			 records need to be up-to-date and available. The auditor will randomly select
			 which subjects will be audited during the visit.
(d)
										A copy of the FDA
			 audit preparation guidance for clinical investigations checklist that
			 highlights what regulatory documents the auditor will be reviewing throughout
			 the internal investigation. The PI is responsible for ensuring that those
			 documents highlighted on the checklist are available during the departmental
			 inspection.
(3)
									The clinical research auditor will coordinate a date
			 and time to meet with the investigational pharmacist (if applicable) to review
			 all study drug accountability and dispensing records.
(4)
									The clinical
			 research auditor will complete an audit review form on every subject monitored
			 during the inspection. The following elements will be reviewed:
(a)
										Informed consent
			 form ("ICF") and documentation of the consent process.
(b)
										Subject
			 eligibility and screening compliance.
(c)
										Protocol required
			 procedures/visits are complete.
(d)
										Adverse and
			 serious adverse events have been properly reported to
			 sponsor/IRB.
(e)
										Lab and diagnostic testing have been performed per
			 protocol requirements.
(f)
										Data collection is attributable, legible,
			 contemporaneous, original and accurate (ALCOA standards for
			 GCP).
(5)
									Exit interview: The PI and key study staff will attend
			 the exit interview or notify the clinical research auditor of the need to
			 reschedule the exit interview. Any rescheduled exit interview must occur
			 without delay. The clinical research auditor will present the findings from the
			 audit and respond to any questions from the PI or research team at the end of
			 the inspection. This is an opportunity for the PI to discuss any issues of
			 non-compliance or other identified issues and provide appropriate
			 clarification.
(6)
									The clinical research auditor will complete a formal
			 internal audit report after the inspection and provide a copy to the PI within
			 ten business days. The auditor will evaluate the areas of study conduct that
			 include human subject protections, protocol and regulatory compliance, validity
			 and accuracy of data, drug and/or device accountability and will assign a
			 preliminary internal audit rating at the conclusion of the inspection. The
			 clinical research auditor may notify the reviewing IRB and/or the appropriate
			 university official(s) of any findings as necessary for the protection of human
			 subjects or compliance with university policies. The PI will have fifteen
			 business days to respond back to the clinical research auditor. Copies of the
			 final internal audit report will go to the dean of the relevant college, the
			 vice president of research, and the executive director of internal audit and
			 chief compliance officer.
(7)
									Internal audit ratings:
(a)
										Exceptional:
			 evidence of consistent good clinical practice ("GCP")
			 compliance.
(b)
										Acceptable: only a few minor deviations
			 noted.
(c)
										Deficient: major protocol violations identified.
			 Requires a written corrective action plan from the PI addressing all areas that
			 require improvement within ten business days.
(d)
										Unacceptable:
			 requires immediate action and a written response from the PI within five
			 business days, including the specific date by which the compliance plan will be
			 fully implemented. The clinical research auditor will immediately notify the
			 appropriate individuals such as the IRB chair or designated IRB contact person,
			 vice president of research, and/or the dean of the relevant college of any
			 suspected human subject safety issue(s) and/or any potential fraud or
			 fabrication violations. The IRB or university officials may take immediate
			 action including suspending enrollment or closing the study, if deemed
			 necessary.
(8)
									Documentation of all internal audits along with PI and
			 IRB/university officials' response (if applicable) will be kept confidential to
			 the extent permitted by law and maintained in the JCCTR internal audit
			 files.