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Compliance In Focus
Posted by Melanie Miller on Tue, Jul 21, 2020

These Online Clinical Research Courses Will Keep Your Team Sharp

With many team members continuing to work remotely, there has never been a better time to invest in online training. IMARC offers affordable online clinical research courses your team can take at their convenience.

clinical-research-courses

These courses are designed to help researchers develop a deep understanding of clinical research regulations and how to apply them so they can succeed in their current role or take the next step in their career.

Here are four of our most popular courses.

4 Clinical Research Courses To Keep Your Team Sharp

1. Foundations Package

Designed for sponsor organizations, project managers, research coordinators and anyone involved in clinical research, this course offers a basic understanding of FDA regulations and human subject protections.

It includes two introductory courses on the FDA regulations, 21 CFR Parts 312 and 812, and 21 CFR Parts 50, 56, 54, and 11. This package also includes a course comparing 21 CFR Parts 312 and 812, as well as a more in-depth course on Human Subjects Protection as required under Part 50. Additionally, the Foundation Package includes courses on Good Clinical Practice, HIPAA in research, and an overview of the history of clinical research.

The package concludes with IMARC’s signature FAIR Shake TM technique, which helps researchers resolve complex questions using a simple framework.

Courses include:

  • An Introduction to the U.S. FDA Regulations
  • Part I: 21 CFR Part 312 and 812 Part II: 21 CFR Parts 50, 56, 54, and 11
  • Comparing 21 CFR Parts 312 and 812
  • Introduction to Good Clinical Practice
  • Introduction to HIPAA/HITECH
  • The History of Clinical Research
  • Human Subjects Protection: Drilling Down 21 CFR Part 50
  • The FAIR ShakeTM Method

2. Monitoring 101 and 102 Packages

Monitoring 101 is ideal for new monitors or monitors who need a refresher in the regulations. It offers an overview of the four types of monitoring visits and the process monitors should follow, as well as what they can do between monitoring visits to keep the trial moving forward.

Courses include:

  • Site Assessment Visits
  • Site Initiation Visits
  • Periodic Monitoring Visits
  • Close-Out Visits
  • Site Management

Our Monitoring 102 Package is for more experienced monitors who want to dive deeper into the requirements for informed consent, document review, source data verification and more. It’s designed to increase competency during on-site monitoring and remote monitoring. Monitors who complete this course should be able to think critically and spot potential errors before they become violations.

Courses include:

  • How to Review Informed Consent
  • How to Review Essential Documents
  • How to Verify Source Data
  • How to Conduct Product Accountability
  • Risk-Based Monitoring Overview

3. Informed Consent: Drilling It Down

This course provides a detailed overview of the regulations and best practices surrounding informed consent. Designed for principal investigators, study coordinators and clinical research staff involved in documenting consent, it goes beyond the basic regulatory requirements and provides practical tools to improve the informed consent process.

This is a four-hour course that can be taken over two live, virtual sessions.

Topics include:

  • Good Clinical Practice and US FDA Regulations Refresher
  • Using the FAIR ShakeTM Method For Challenging Research Situations
  • Human Subject Protection Covering Informed Consent
  • Conducting and Documenting Informed Consent: Best Practices

4. FDA Inspections

This course provides participants with more context about why, when and how FDA inspections occur. They’ll gain a detailed understanding of the FDA’s compliance program guidance manual, the items assessed by FDA inspectors and best practices to help research teams prepare for and host inspections.

By the end of the course, they should understand potential inspection outcomes for investigators, describe key topics assessed in the FDA’s BIMO Guidelines for site inspections and connect these with examples of evidence the FDA will review. This knowledge will set the foundation for quality assurance activities and help them approach FDA inspections with confidence.

Training Guide and Course Catalog 2020

How To Enroll In Our Online Clinical Research Courses

Investing in training helps you ensure everyone at your sites follows a consistent approach and is able to think critically to solve challenges as they arise, using the regulations as their guide.

Our clinical research courses are designed for all roles and levels, from beginner to advanced.

The courses make online learning interactive with group activities, case study discussions, games and quizzes.

If you’re ready to enroll your team in online clinical research courses, check out our newly updated training catalog. You can search for courses by role, by type and by topic.

Our team can also work with yours to develop customized training programs depending on your needs, including a hybrid approach that includes both in-person and online learning.

Invest in your team today so they will continue to excel tomorrow.

Learn more about our online training solutions.

Topics: IMARC University

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