Audits

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 of DF/HCC research.

Internal Audits

All clinical trials conducted at DF/HCC participating institutions are subject to internal audit by the Office of Data Quality, including those trials sponsored by NCI, pharmaceutical industry or other sponsors. Internal audits are conducted according to the Audit Manual.

The goals of the auditing process are:

  • To ensure and confirm ongoing protocol compliance in accordance with DF/HCC guidelines, policies and procedures, and US federal regulations.
  • To educate the clinical research staff and promote greater awareness and understanding of policies, procedures and objectives, and to increase efficiency and consistency in the conduct of clinical trials at DF/HCC.
  • To identify areas where systemic process improvements in the DF/HCC policies and procedures is needed to ensure compliance and enhance participant safety.

Hide

Audit Process

This workflow outlines the general process and timeline of an ODQ Internal Audit.

Hide

Audit Selection

The Office of Data Quality implements a risk-based approach, following the philosophy described in the FDA’s guidance on risk-based monitoring, to select clinical trials for routine audits. 

The following factors are considered:

  • 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

In addition to routine audits, the Office of Data Quality may conduct other types of audits, including:

  • Targeted - A systematic review of a specific aspect of the 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.
  • For Cause - An audit requested by a DF/HCC oversight committee (CLC, IRB, DSMC, DSMB, etc.) or DF/HCC leadership in response to specific observations or concerns.

Hide

External Audits

DF/HCC has a vested interest in the quality of the research that is performed by consortium members and in maintaining its collective reputation as an outstanding research center. Therefore, the Overall PI or responsible clinical trials office must inform key leadership and study personnel of pending inspections/audits and their outcome. 

  • 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 DF/HCC Policy: AUD-102.
  • Throughout the audit/inspection, be sure to follow processes outlined in DF/HCC Policy: 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.