Topics
- Types of clinical investigator financial interests that you must report.
- Clarification of the definition of financial interest
- Specific concerns for different kind of products: drug, biologic and medical device
- How and when to collect and report the financial disclosure information
- What needs to be disclosed?
- Forms to be used for collecting this information
- Who is covered and who is responsible for reporting to FDA?
- Changes in financial disclosure information during a trial
- What would FDA reviewers of marketing approval application and FDA auditor`s look for in financial disclosure data?
- What kind of clinical trials are covered under the current rules?
Who should Attend
Clinical trial professionals (e.g., CRAs, coordinators), Compliance/Regulatory affairs professionals, Sponsors and investigator-sponsors of clinical trials, Investigators participating in clinical trials, Project Managers, Clinical trial specialists and People investing in FDA-regulated product development projects.
