Being Inspected: What is It Like?
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Copyright Q 1998 Drug Information Association Inc.
BEING INSPECTED: WHAT IS IT LIKE? NEALR. CULTER, MD Director, California Clinical Trials, Beverly Hills, California
An audit, or “inspection, ” is an expected event in the course of New Drug Application (NDA)approval, typically involving pivotal Phase I l l or bioequivalency studies. Whether concurrent with these landmarks or prompted by suspicion that the study site failed to adhere to regulatory starrdords, the inspector will verify that informed consent was obtained, real patients were enrolled, the protocol was adhered to, Good Clinical Practice was used, medication was administered, log sheets were kept, and data reported were correct. Recommended tools for completing a successful inspection are Organization, Documentation, and Cooperation. Key Words: Audit; Inspection; Clinical research;Food and Drug Administration; Regulatory standards; Good Clinical Practice
INTRODUCTION
1. Be organized, 2. Document, and 3. Consider the inspector an ally, not an adversary.
CLINICAL TRIALS ARE OF paramount interest to regulatory agencies as the culmination of years of research and, more importantly, because they deal with human subjects (1). Considering this, clinical investigators What Prompts an Inspection? must be prepared at all times for study audits, or as the Food and Drug Administration Inspections can be routine, or prompted by (FDA) terms them, “inspections.” Interna- questions or suspicions about a study or study tionally, the standardization of regulatory in- site (6). Routine inspections of clinical studspections is of growing priority (2-5). The ies may be random, but often arise in conauthor’s experience as the director of a clini- junction with NDA approval. Similarly, pivcal investigation organization for over 10 otal Phase I11 trials and bioequivalency years is offered to provide insight on critical studies often prompt routine inspections. elements, and advise on how best to prepare These routine inspections will likely be no less thorough than one prompted for probfor and complete a successful inspection. There are three themes which will recur lematic reasons, but the site may at least have the advantage of not starting off under suspithroughout this paper: cion in the mind of the inspector. A study may draw suspicion for a variety Presented at the DIA “Advanced GCP Workshop: New of reasons. For example, the regulatory Techniques.” September 15-1 7. 1997, Philadelphia, agency may be unfamiliar with the study site, Pennsylvania. Reprint address: Neal R. Cutler, MD. Director, Cal- and choose to become acquainted through an ifornia Clinical Trials, 8500 Wilshire Blvd.. 7th floor. inspection. Advertising for clinical studies may capture the attention of a regulatory Beverly Hills, CA 902 I 1 . 1043
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Neal R. Cutler
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agency, particularly if the advertising is making any type of extraordinary promises to potential patients. Study participants, if dissatisfied with
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