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CLINICAL RESEARCH TRAINING

CLINICAL RESEARCH COORDINATOR: ADVANCED CONCEPTS

COURSE DESCRIPTION:

This course provides a refresher and additional training for the experienced clinical research coordinator (CRC). We will start with a refresher on GCP and the key regulations and guidelines governing medical device clinical research. Then we will explore the importance of good study management and documentation, industry trends and best practices at the research site. We will also cover inspection preparation, as well as CAPA planning and implementation.

LEARNING OBJECTIVES:

  • Identify applicable ICH GCP E6 R2 and ISO 14155 guidelines and FDA regulations governing clinical research

  • Explore ‘controversial’ topics in research, such as using notes-to-file, delegation logs and consent notes effectively using well-supported arguments

  • Discuss study management and best practices for securing compliance in device studies

  • Understand the mechanics of FDA inspections and describe at least three (3) recommendations to help sites and sponsors be inspection ready.

COURSE OUTLINE

AGENDA 8:30 am - 4:30 pm 

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

  • FAIR ShakeTM Critical Thinking Method for Answering Challenging Research Questions

  • Securing Compliance in Device Studies: Effective Study Management

    • Best Practices: Informed Consent, Adverse Event Managing and Reporting, and Maintaining Study Documentation

    • Protocol Deviations: Identifying, Documenting and Reporting

    • Corrective and Preventative Action Plans: Identifying, Documenting and Implementing to Improve Site Compliance

  • Debate Club: Notes-to-File, Delegation Logs, Consent Notes

  • Being Inspection Ready: Understanding the FDA BIMO Inspection Process for Sites

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 Research Coordinators, nurse coordinator, site manager, or investigator with solid background in FDA and GCP

  • Staff involved in or manages daily operation of clinical research at a trial site 

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