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.

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. 

Audit Process

Expand this section for an overview of the typical internal audit process. More information can be found in the 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
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Purpose

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

  • 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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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-102.
  • Throughout the audit/inspection, be sure to follow processes outlined in AUD-102  and provide ongoing communication to the appropriate parties.
  • Refer to the guidance documents below, or contact your institutional clinical trials office, for more information.