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CLINICAL RESEARCH TRAINING

Clinical Research Auditors: Comprehensive Training

COURSE DESCRIPTION:

The goal of the training is to provide an introduction to the job function of the Clinical Research Auditor. The course is structured for individuals seeking to learn more about GCP auditing, including site and sponsor/CRO audits, as well as vendor audits.

LEARNING OBJECTIVES:

  • Describe and discuss FDA regulations and Good Clinical Practice

  • Explains roles and responsibilities of a Clinical Research Auditor

  • Describes types of audits, and the responsibilities of the auditor in preparation, activities, and follow-up

  • Examine and apply the FDA’s methods for inspection of Clinical Investigators, and Sponsor/CROs

  • Discuss Inspectional Findings, regulatory compliance, quality issues and documentation

COURSE OUTLINE

AGENDA: 8:30 am - 4:30 pm

  • Good Clinical Practice and U.S. FDA Regulations Refresher

  • FDA BIMO Inspections and Guidances

  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Auditing Overview

  • Audit Preparation: Developing the Audit Plan and Preparing for the Audit

  • Conducting Audits

    • Investigative Sites

    • Sponsor/CRO

    • Clinical Vendor Assessments

  • Spot Checking: Sampling Documents and Data For Trend Analysis

  • Audit Report Writing and Post Audit Documentation

  • Communicating Findings with Auditees and Clients

TYPE

  •  In Person Training – At IMARC or Your Location
 
CONTINUING EDUCATION CONTACT HOURS (CEUs)
7.0 hours (0.7 CEUs)

 

KNOWLEDGE LEVELS:

  • Intermediate
  • Experienced

 

WHAT’S INCLUDED

  • Interactive Presentations
  • Case Studies and Scenarios
  • Handouts and References (Whitepapers and Infographics)
  • Certificate of Completion
 
 

Training Solutions For These Roles

  • Clinical Quality and Compliance Professionals

  • New and Aspiring Auditors

  • Clinical Research Associates and Project Managers

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