Course Description

This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations.  Significant updates to the seminar focus on the development and utilization of Quality Systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

Learning Objectives

• Apply auditing standards based in current law, regulations, and guidelines
• Utilize electronic systems to enhance your auditing techniques, allowing more efficiency in your daily monitoring or auditing activities
• Understand the role of quality systems in GCP, including techniques for detecting root causes of performance deficiencies and developing and implementing effective Corrective and Preventive Action (CAPA)
• Select investigators and records for auditing or special monitoring emphasis
• Conduct clinical investigator audits
• Detect, prove, and prevent scientific fraud and misconduct
• Learn techniques for writing audit plans and reports

Who Should Attend

• Clinical Quality Assurance Professionals who audit the quality of clinical trials
• Clinical Research Associates and Managers, Project Leaders, and Medical Monitors who want to enhance their effectiveness
• Regulatory Affairs Professionals responsible for GCP regulatory compliance
• Investigators, Study Coordinators and Trial Center Managers who want to learn how to prepare for FDA and sponsor audits and to improve the quality of their research activities

Instructor

The course will be led by one of the following instructors:

Elizabeth Ronk Nelson, M.P.H.

Shana Zink, B.S., C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• The Standards: Important aspects of GCP-related law and regulations: Food, Drug, and Cosmetic Act, Title 18 Criminal Statutes, HIPAA, 21CFR 11, 50, 54, 56, 312, and 812; Corporate standards
• Trial Center Auditing Methods: Selecting centers to audit, auditing and inspection procedures and methodology, including special procedures for “e-trials”; differences between auditing and monitoring; Defining and determining the adequacy of source documentation; developing and implementing Simple, Effective, and Efficient Quality Systems to improve clinical site performance
• Fraud and Misconduct: Motives; discovering, reporting, and preventing fraud and misconduct, including special techniques for e-trials

Day Two

• Data Trend Analysis: Definition and description of this special auditing technique; multiple examples; how to practically use this technique; Special subsection on detecting the signs and symptoms of impeding failure at a trial center
• Auditing Techniques Exercise: Perform data trend analysis; audit to determine document validity and data accuracy; perform root cause analysis; build a CAPA; work individually and within a group of your peers
• Essential Documents: Define and prioritize; auditing the essential document binder or files; the legal and regulatory basis behind the EDs
• Enforcers and Enforcement: The compliance organizations in CDER, CBER and CDRH; FDA inspection results and consequences of adverse findings; how to manage a regulatory authority inspection; FDA’s Application Integrity Policy
• Summary of Auditing and QS Processes: Audit Planning, Notifications, Conduct, Reporting; Root Cause Analysis; developing and implementing CAPAs

Interactive Activities

• Perform Data Trend Analysis
• Accomplish an Audit of Source Documents and CRFs
• Work on an Audit Team to Discuss and Present Findings

Registration Fees

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-001-L04-P. Released: 3/22.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.