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CLINICAL RESEARCH TRAINING

MEDICAL DEVICE CLINICAL RESEARCH: BEYOND THE BASICS BOOT-CAMP FOR CRAS AND PMS 

COURSE DESCRIPTION:

The goal of the training is to provide a refresher on GCP and regulations governing medical device clinical research, as well as an energizing exploration of the importance of good monitoring and site management practices, methods for thinking strategically and critically, and industry trends and best practices. The theme of the training will be to highlight the importance of supporting site compliance, efficiency, timelines, enrollment, data quality, and ultimately, the approval of an investigational device.

LEARNING OBJECTIVES:

  • Identify applicable ICH GCP E6 R2 and ISO 14155 guidelines and FDA regulations governing clinical research
  • Navigate through the requirements governing clinical research using critical thinking skills 

  • Explain the important role of clinical research monitors and those conducting site management activities and how they can secure 
compliance on behalf of the sponsor 

  • Describe best practices for creating and maintaining high quality documentation in research at sites 

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

  • Recall requirements and methods for maintaining a compliant trial master file 

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

COURSE OUTLINE

DAY ONE 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

  • Best Practices for Effective Monitoring and Site Management

    • Take Your Monitoring from GOOD to GREAT

    • High Quality Documentation and Maintaining the Sponsor TMF

    • Adverse Event Reporting for Medical Device Trials

    • Writing Excellent Reports

    • Treating Your Sites Like Customers

    • Follow-up and Follow Through: Effective Site Management

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

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

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
  • Certificate of Completion 
 

Training Solutions For These Roles

  • Clinical Research Associates and Project Managers
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