Good Clinical Practices (GCP) & Risk Based Monitoring: Understanding and Implementing Current Global Requirements

As patient recruitment for clinical trials continues to rise, pharmaceutical professionals in the United States and other parts of the world must keep their skills sharp and be up-to-date with the current regulations. With quality assurance and clinical research roles often centered around data collection and supervision relating to patient treatment in clinical trials, employers must be confident that employee knowledge of GCP is unmatched; otherwise, they risk drug recalls or poor inspections that can result in bad press.

What Does Clinical Investigation Monitoring Entail?

Clinical investigation monitoring is a quality control tool that determines if companies carry out investigation activities as planned and includes details such as:



• Signed and dated patient consent forms prior to any trial procedures
• Verified documentation showing the patient meets all criteria for eligibility
• Confirms that all necessary materials and equipment are present
• Verifies proper storage of materials, drugs, and samples — refrigerate, frozen, or shelf?
• Checks that inventory corresponds with current counts
• Random reviews of procedures and processes 
• Cross-check source data versus the case report form (CRF) to ensure proper documentation of adverse events (AEs) and serious adverse events (SAEs) 
• Confirms the reasoning for trial participant dropout
• Checks for proper documentation in the CRF of drug administration modifications, side-effects, and concomitant diseases to transmit reports for round-table discussions with the general coordinator, trial monitor, and the investigator

What is Risk-Based Monitoring (RBM)?

Risk-Based Monitoring is a viewpoint in clinical trial management that centers on identifying, addressing, mitigating, and preventing risks that could impact participant safety, trial quality, or data integrity. 



FDA guidance suggests three steps in an RBM approach:

• Detection of Processes and Critical Data: Before you can flag critical data as a potential risk, you must first identify the acceptable/expected parameters and values. You can use intelligence from previous studies to help quantify and identify these metrics as low, medium, or high risk. Mitigating an identified risk can change throughout the trial period, so you don’t need to enter the risk category initially. Some examples of high-risk critical data include anything impacting patient safety or trial sites with little experience with endpoint data categories or clinical trials.
• Perform a Risk Assessment: After identifying risks, use the ‘traffic light system’ to help visualize the degree of severity — red-high, yellow-medium, and green-minor. You must conduct a risk assessment to convey these findings to the trial site. This involves source data review (investigating the risk and its origin), implementing risk mitigation methodologies, and starting corrective actions to resolve current risks and prevent further ones. Some corrective actions may include motivational visits to the site, re-education of the site, escalating to a global level, amending a recruitment plan, or in extreme cases, issuing warning letters.
• Develop a Monitoring Plan to Incorporate a Risk-Based Approach: The RBM approach is quickly becoming an integral concept in clinical research for the pharmaceutical industry. And just in time — the FDA wants to implement a monitoring plan that describes the trial's monitoring methods, requirements, and responsibilities.  This document will stipulate the data points and how often they need monitoring, coupled with escalation and communication plans for everybody involved in the trial. The RBM strategy can improve data quality and reduce clinical costs while reducing the time it takes to approve Investigational Medical Products (IMP). 

The FDA performs statistical analyses on all submitted data sets and is essential to the approval process. They strongly suggest that all ongoing and not yet commenced clinical studies integrate some degree of statistical monitoring and RBM to meet the recently implemented standards.

How Long Does It Take to Get the Good Clinical Practice Certification?

CfPIE’s Good Clinical Practice course is three days of knowledge-packed hands-on experience with proven techniques in detecting, preventing, and correcting clinical study deficiencies by maximizing risk-based considerations. Attendees will also gain further knowledge of 24 clinical trial-related topics and full GCP certification.  

Is the Course Compliant with FDA Regulations? 

CfPIE’s GCP course complies with EU and FDA regulations and the ICH Guidelines (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).

Is the GCP Training Course Regularly Updated? 

This course is up-to-date with current regulations and facts. Any new criteria or changes in rules will be part of the course.

What is the GCP Standard for Good Clinical Practice? 

Good Clinical Practice is an international, scientific, and ethical quality standard for creating, conducting, documenting, and reporting trials involving the participation of human subjects. Compliance with this standard ensures the public the protection of the trial subject’s rights, safety, and well-being.

What is the GCP Definition of Monitoring? 

In terms of Good Clinical Practices, monitoring is the act of supervising the progress of clinical trials and ensuring that conducting, recording, and reporting the clinical trial is in accordance with protocols of SOPs, GCPs, and applicable regulatory requirements such as FDA and ICH Guidelines.

Make the Most of Your Career With CfPIE — The Leader in GCP Training

Exceeding your GCP training requirements not only makes you more effective in your job but it also strengthens your experience and skills and helps you impress future employers. When your skills are up-to-date, you have the necessary tools and knowledge to stand out from the competition and excel in your role. 

CfPIE’s GCP certification training provides practical and real-world examples that you can immediately put into practice so there’s no time wasted when bolstering your career. 

About CfPIE

The Center for Professional Innovation and Education (CfPIE) is the global leader in life sciences training, providing specialized courses for pharma/biotech, medical device, and skin/cosmetics topics. Classroom and custom on-site formats, and certification programs help improve personal skills, maintain regulatory compliance, and advance careers. Small class sizes and industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction. More information: https://www.cfpie.com