FDA Inspectors Demand CAPA Documentation

Clinical researchers who fail to adequately document corrective and preventive action (CAPA) programs are missing out on a number of important benefits to save time and money, says Beth D. Harper, MBA, president of Clinical Performance Partners, Inc.

“It’s not just a compliance tool,” she stresses. Instead, CAPA can be leveraged to dig deeper and identify root causes. Think of it as an opportunity to critically examine how you do things and look for ways to improve them. “Why do we devote time to it only in panic mode?”

CAPA capabilities are often the first thing a U.S. Food and Drug Administration (FDA) expert will examine when onsite. Deficiency in this area is usually the most cited issue in Warning Letters across all aspects of industry, including medical devices, pharmaceuticals, and clinical trials. In a recent Warning Letter to a clinical researcher, FDA acknowledged the firm said it had addressed shortcomings and taken corrective action, including:

The research coordinator who falsified data was terminated; All investigators and staff must attest that they have read and will adhere to the department’s Standard Operation Procedures when conducting research; The department will conduct comprehensive standardized training and competency validation for all new research coordinators; The Department of Medicine research manager and staff will perform continuous internal monitoring of studies; Study-specific enrollment criteria for all studies will be reviewed at weekly department research meetings, and investigators will be required to sign eligibility checklists.

However, FDA rejected the response because the clinical researcher failed to adequately document the changes. “We have to think differently about CAPA,” Harper stresses. A good plan isn’t always enough.

A defensible, documented CAPA program can also give a clinical researcher valuable confidence, notes Glenda Guest, CCRA, RQAP-GCP, TIACR and Vice President at NCRA. “If you understand the flexibility of [many] FDA requirements, you can be assertive and defend” the way you operate, she says.

Harper and Guest will present separate sessions sharing the latest CAPA tools and tactics at the ACRP 2016 Meeting & Expo, April 16-19, in Atlanta. Ga. For more information, visit:

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