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Compliance In Focus
Posted by John Lehmann on Wed, Feb 5, 2020

Everything You Need To Know About Clinical Monitoring

Clinical monitoring is the foundation for IMARC's services and a critical part of ensuring compliance. It's so fundamental, in fact, that sometimes it's easy to overlook the basics. 

In this post, we'll take a closer look at what monitoring entails and five steps you can take to ensure success. 

5 Monitoring Steps

What Is Clinical Monitoring?

The FDA defines clinical monitoring as the act of overseeing an investigation. It requires sponsors to  identify investigators who are not complying with the federal regulations, the agreements, the clinical investigational plan (CIP), or the requirements of the Institutional Review Board (IRB). Sponsors are also required to secure compliance or discontinue shipments of the device (21 CFR 812.46). The International Organization for Standardization (ISO), the organization that provides international guidance for the medical device industry further describes monitoring as the act of ensuring that a clinical trial is conducted, recorded, and reported in accordance with the CIP, written procedures, this International Standard, and the applicable regulatory requirements” (ISO 14155:2011(E), 3.29).

Specifically noted in 21 CFR 812.43, sponsors are required to select monitors qualified by training and experience. In addition, 812.46 states that monitoring investigations should include securing compliance at investigative sites, whenever necessary.

Benefits of Clinical Monitoring

Clinical monitoring offers several benefits to sponsors, including: 

  • Ensuring the protection of clinical trial subjects
  • Ensuring data integrity
  • Ensuring compliance with federal regulations, agreements, clinical investigations and the IRB
  • Identifying and addressing non-compliance
  • Identifying research misconduct or fraud

A well-trained team of clinical research monitors will ensure all your sites follow a consistent process. They can also catch any errors in your data before they become bigger issues. 

5 Steps To Clinical Monitoring Success

At IMARC, we believe monitoring matters and have created a whitepaper outlining five steps your team can take to ensure monitoring goals are achieved.

They are:

1. Identify Quality Monitors

2. Develop a Monitoring Plan

3. Perform Monitor Training to Ensure Proper Execution

4. Identify and Document Findings

5. Secure Compliance

The importance of the monitoring function in clinical trials cannot be underestimated. The end-goal is to ensure a well-controlled, compliant clinical study in which human subjects are protected and the resulting data is evaluable. Achieving this goal takes diligent efforts on the part of sponsors, monitors and investigational site staff, working together as a study team. In taking the five steps for monitoring outlined above, sponsors may avoid costly clean-up efforts, prevent a warning letter, ensure that data is credible and reliable, and ensure that all human subjects were protected throughout the process. Monitoring definitely matters!

Please take time to download IMARC’s whitepaper and provide us with your thoughts.

Monitoring as a Mindset Blog CTA

photo credit: Thomas Hawk Boston via photopin (license)

Topics: FDA, Clinical Trial Monitoring

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