In this GCP compliance webinar learn how to prevent and handle protocol deviations and violations
Areas Covered in the Seminar: - The Primacy of the study Protocol.
- What are Protocol “Deviation” and other terms / categories.
- The many cause of protocol deviations.
- The Regulatory requirements for handling protocol deviations and violations.
- The importance of documentation of protocol deviations as well as violations.
- How to define and handle instances of PNF.
- What is the reason different IRBs define deviations and violations differently.
- What is the basis of the difference between a “Deviation” and a “Violation”.
Who Will Benefit:This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
