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CLINICAL RESEARCH TRAINING

Best Practices for Experienced Investigators & Coordinators

COURSE DESCRIPTION:

The goal of the training is to provide a refresher on GCP and regulations governing clinical research, as well as an energizing exploration of the importance of ensuring compliance, methods for thinking strategically and critically, and industry trends and best practices. The theme of the training will be to highlight the importance of conducting trials in compliance with the protocol and GCP, improve study coordination, and reduce the risk of inspection findings.

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

  • Understand what to expect from monitor visits and how to work well with your monitor

  • Describe best practices for creating and maintaining high quality documentation in research using ALCOA-C

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

  • Understand the mechanics of and how to prepare your site for FDA inspections and Sponsor audits

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

  • Best Practices for an Effective Site

    • Human Subject Protection and Informed Consent

    • High Quality Documentation

    • Adverse Event Classification and Reporting

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

  • Understanding Clinical Research Monitoring

    • How to work well with your monitors

  • 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
  • Certificate of Completion
 

Training Solutions For These Roles

  • Investigators and Site Personnel

  • Experienced Coordinators seeking to enhance or refresh their skills to more effectively and efficiently manage studies

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