Conducting a Clinical Research Department Process Audit: Methodology and Findings
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0092-8615/99 Copyright 0 1999 Drug Information Association Inc.
CONDUCTING A CLINICAL RESEARCH DEPARTMENT PROCESS AUDIT METHODOLOGY AND FINDINGS DOUGLAS R. MACKINTOSH, D R P H , MBA, MsHYG President
VERNETTE J. MOLLOY,M B A , RN Vice President GCPA, Incorporated, Fairfax, Virginia
Process audits of clinical research departments focus on the extent of regulatory compliance, scientific integrity, and sound business practices of various functions performed by the department. This paper describes the objectives, methodology, and $findings of process audits. It also identifies key markers examined by auditors for each of the line and staff functions performed by clinical departments conducting research studies. Key Words: Process audits; Clinical research department
“What we see depends on mainly what we look for.” John Lubbock
INTRODUCTION PROCESS AUDITS DETERMINE the extent of Good Clinical PracticelInternational Conference on Harmonization (GCP/ICH) compliance, scientific integrity, and sound business practices of various functions performed by an organization. Compliance, when used in the context of this paper, refers to conformity to scientific rigor and regulatory standards and guidelines. Candidates for these audits include clinical research departments of pharmaceutical, device, and diag-
Presented at the DIA 3d Annual Workshop “GCP Audits and Surviving an FDA Inspection,” Seattle, Washington, April 26-27. 1999. Reprint address: Douglas R. Mackintosh, DrPH, MBA. MsHYG, President. GCPA. Incorporated. Suite 145, 12500 Fair Lakes Circle, Fairfax, VI 22033. E-mail: [email protected].
nostic manufacturing firms which conduct clinical trials and are responsible for postmarketing surveillance. Process audits are sponsor audits, not investigational site audits. Reasons for conducting process audits vary, but focus on four motives: 1. Potential for a regulatory inspection, 2. Desire to improve effectiveness and efficiency, 3. Benchmarking against other clinical departments, and 4. Satisfying concerns of upper level management.
Process audits may, as their objective, address any and all of these factors, but it should always be clear, before an audit begins, who the customers are for such audits. The following are possible objectives for a process audit: 0
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To determine if existing standard operating procedures (SOPS) and other documentation are sufficient and relevant to current operational practices,
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Douglas R. Mackintosh and Vernette J. Molloy
*To determine if there are any major flaws others are small “virtual” organizations that or gaps in workflow, operations, or docu- outsource most activities, Some include rementation; to improve workflow and to form sponsibility for data management and statisthe basis for a quality improvement effort, tical analysis and others do not. Almost all To determine whether there are adequate clinical departments have some line funcand well-controlled procedures in place to tions and some supp
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