In this FDA clinical trial training get guidance and learn to interpret various clinical trial requirements and regulations. The general scientific principles for the conduct, performance and control of clinical trials will be examined.
Why Should You Attend:
Navigating through the various FDA clinical trial requirements, regulations and guidelines can be confusing and time consuming. Failure to comply with the regulations and requirements can be devastating to any clinical project.
This session will include the FDA requirements and regulations for sponsors/CROs and investigators. FDA regulations and guidelines will be integrated with techniques and tips for navigating through the various requirements for clinical trials all in an understandable language. This session will include the requirements for the key documents needed for any clinical study and the requirements for maintaining that documentation. Additionally, the most common FDA inspection findings cited from their BioResearch Monitoring Program will be covered with tips on how to ensure these areas are complied with.
Areas Covered in the Seminar:
- Clinical Trial Protocol and Amendments.
- Investigator's Brochure.
- The FDA Form 1572.
- The Informed Consent Form.
- Assurance of IRB Review.
- Protection of Human Subjects.
- Financial Disclosure.
- Electronic Records/Electronic Signatures.
- Requirements for Sponsors/CROs.
- Requirements for Investigators.
- Most cited FDA findings from Bio Research Monitoring Program.
- Investigator Disqualification.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Pharmaceutical
- Biotechnology
- CROs
- Research facilities conducting clinical trials
Instructor Profile:
Carol Owen, has been in the Clinical Research Industry for over 20 years. She recently held the position of Director of Quality Assurance for a large Contract Research Organization. She has been involved in training throughout her career particularly in the areas of GCP compliance, FDA regulations and requirements, and audit training. She has specialized in the pharmaceutical clinical trial business having previously worked for an international pharmaceutical company and two international CROs. She has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials.
