Who Should Attend
This 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.
Learning Objectives
Upon completion, attendees will be able to:
- Identify and define the principles and requirements for GCPs
- Define the basic roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
- Learn the similarities and differences in GCP for drugs, device and biologic studies
- Understand how GCPs can impact clinical research progress and ensure that GCPs are implemented
- Clearly put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
- Ensure that your data and supporting documentation are accurate and presentable for inspection
- Comply with informed consent and Human Subject Protection requirements
- Learn how to detect and prevent fraud and misconduct in clinical trials
Course Description
By the end of this course, participants will have a detailed understanding of how to:
- Identify and define the principles and requirements for GCPs
- Define 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
- Recognize how GCPs can impact clinical research programs
- 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
This training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. 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. 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.