This GCP compliance training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. The FDA supports clinical trial sponsors to use risk-based site monitoring. That's a plus for many sponsors, but you have to have the quality risk management system in place to make it work. This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. This will include practical knowledge on how to implement a risk-based monitoring approach to quality in clinical trials.
Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites by maximizing risk-based considerations. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies.
Who Should Attend
This two-day course will benefit those involved in the monitoring and/or QA of clinical trials. Employees who work for Pharmaceutical or Biological firms, Contract Research Organizations, Medical Device companies and academic institutions involved with the supervision or oversight of clinical trial practices and policies will find this course of interest.
By the end of this course, participants will have a detailed understanding of how to:
- Identify and define the principles and requirements for GCPsDefine the roles and responsibilities of sponsor, monitor,
- investigators and FDA as they relate to the quality of clinical trials
- Recognize clinical trial documentation differences for drug, device, and biologic studies
- Define risk-based monitoring and how to implement plans and maximize the quality in a risk-based environment
- Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
- Understand what happens during a GCP inspection
- Detect and prevent fraud and misconduct in clinical trials
- Ensure that your data and supporting documentation are accurate and in the right format for inspectors
Frequently Asked Questions
What does Monitoring mean for clinical trials?
Monitoring is the ongoing process of overseeing a study to ensure patient safety, data quality, protocol compliance, and regulatory compliance. It includes all of the activities performed to assure the quality of the study data and safety and integrity of the conduct and the subjects involved in the study.
Is a company required to perform 100% monitoring or SDV for a study to be acceptable to FDA?
The FDA has never required a company perform 100% monitoring or source data verification (SDV) of the study data. This was a standard developed as an industry practice to assure the highest quality data. This was started at a time before the use of computers and electronic technology to assist with the assurance of quality data. Many alternatives to performing 100% SDV that can also provide high quality data and a complaint study.
How is remote monitoring performed and what does this mean?
Remote monitoring includes all of the processes and systems we use to oversee the performance and quality of the study data. It does not mean you sit in your office and do the same activities you used to do on site from a remote location. Remote monitoring encompasses a different set of tools and approaches to assure the quality of the study data, including the use electronic technology to assist in the process, coupled with some source data verification.