Audits

The DF/HCC has a vested interest in the quality of the research that is performed and in maintaining its collective reputation as an outstanding research community. Auditing helps to ensure the protection of human subjects and the quality and integrity of the data and information submitted to the Institutional Review Board (IRB), Sponsor, and regulatory authorities.

The Office of Data Quality is responsible for internal auditing of clinical trials within the DF/HCC, and tracking the conduct and outcome of external audits and inspections.

External Regulatory Inspections Contact List AUD-OP-1: Internal Auditing Procedures (prev. Audit Manual)

Resources

DF/HCC Policies and Operations

Internal Audits

All research under the auspices of the DF/HCC may be subject to internal audit by the Office of Data Quality, including those trials sponsored by NCI, pharmaceutical industry or other sponsors.

Purpose

ODQ's internal auditing process is not focused on finding fault, but providing opportunities for education and continuous improvement. Our goals include:

To verify that appropriate prodcedures were followed to protect the rights and safety of trial participants.
To confirm and ensure ongoing protocol compliance in accordance with DF/HCC policies and applicable regulations.
To promote greater awareness and understanding of DF/HCC policies, procedures and systems, in order to ensure the consistent high quality of research conducted within the DF/HCC.
To identify areas for systemic and policy-level improvements in order to increase both efficiency and compliance.

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Audit Process

Expand this section for an overview of the typical internal audit process. More information can be found in DF/HCC Operation AUD-OP-1: Internal Auditing Procedures (previously titled Audit Manual).

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Audit Selection

We only have the opportunity to review a subset of the research activities that occur under the DF/HCC. We select protocols and processes to audit using a risk-based approach, akin to the philosophy described in the FDA’s guidance on risk-based monitoring.

Our audit selection algorithm uses the following factors to ensure we are making an objective selection that is appropriately weighted based on risk:

Trial Type (e.g., interventional, observational)
Phase (I, II, III)
Sponsor Type (Institutional, Industry)
IND/IDE Status (for Institutional trials)
Accrual Status / Duration
Investigator Experience

Once a protocol is selected, the initial audit notification is typically distributed ~6 weeks in advance. This notification will include a window during which the audit should occur.

We then work with the investigator and study team to confirm the most appropriate time and space for the audit. Once the audit dates are agreed upon, we will assign the specific auditor(s) that will be working with you. The auditor(s) will confirm the schedule via email and provide more details ~2 weeks prior to audit start.

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Audit Types

Not all audits are the same! The ODQ performs different types of auditing activities depending on the situation.

Full-Scope Audit -A comprehensive review of all clinical research activity under a specific protocol at one or more research locations.
Process Audit - A systematic review of a specific aspect of a single clinical research process across trials, disease programs, and research locations.
Mock - An informal audit performed to assist in preparations for an external audit or inspection.
Audits may also be requested by a DF/HCC oversight committee (CLC, IRB, DSMC, DSMB, etc.) or DF/HCC leadership in response to specific observations or concerns.

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Audit Ratings

Individual audit observations may be assigned as Major or Minor observations. The number and type of observations determine the overall rating for each audit component.

Major is used for non-compliance that has the potential to significantly impact the integrity of the study data (e.g., ability to evaluate the effectiveness of an intervention or its toxicity), the safety or rights of study subjects, or clearly violates applicable regulations or DF/HCC policies. In addition, cumulative minor observations that are similar in nature and indicate possible systemic non-compliance may be considered major.

Minor is used for instances of non-compliance that do not significantly impact evaluability or integrity of the data, or the safety and rights of study subjects.

Each audit component (i.e., regulatory, pharmacy, and subject cases in a Full-Scope audit) receives a rating as follows:

Unacceptable

Multiple major observations within a single component. Typically, this means 2+ or more major observations in either the regulatory or pharmacy component, 2 or more major observations impacting more than a single subject case, or 3 or more major observations across all subject cases.

A single flagrant deficiency (e.g., life-threatening major observation, or a concern for misconduct or fraud)

Acceptable, needs follow-up

Multiple minor observations
Any major observation

Acceptable

No major observations
Few, if any, minor observations

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External Audits

DF/HCC research is subject to external audit and inspection by regulatory authorities and sponsors. Prompt notification to institutional and DF/HCC officials is required whenever an external audit is expected. to ensure inspections and audits.

If you have been notified of an external audit or inspection, please contact your institutional clinical trials office immediately.
With the assistance of the institutional clinical trials office, send formal DF/HCC notification to applicable parties on the External Audit Contact List by following the procedures outlined in AUD-OP-2: FDA and Other Regulatory Inspections.
Throughout the audit/inspection, be sure to follow processes outlined in AUD-OP-2 and provide ongoing communication to the appropriate parties.
Refer to the guidance documents below, or contact your institutional clinical trials office, for more information.

AUD-OP-2: FDA and Other Regulatory Inspections Guidance on Responding to Audit Findings