This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication. One of the most common inspection findings is a failure by the Investigator '…to conduct the studies or ensure they were conducted according to the investigational plans'. Often, the citation isn't just that the protocol wasn't followed but that documentation surrounding management of the issue is insufficient. Therefore, Sponsors are well served by having an effective process to identify, document, and communicate departures from the investigational plan. This presentation will discuss the rationale for a process and offer suggestions including definitions and methods for documentation and communication.
Areas Covered in the seminar:
- The Purpose of the Process.
- Definitions: Deviation...Violation…?
- Suggestions for Documentation and Communication.
Who Will Benefit:
This webinar will provide valuable information to biotech and pharmaceutical professionals who are responsible for developing overall operational procedures or are planning and starting-up new trials, including development of monitoring plans and tools. Employees who will benefit include:- Clinical Project Managers/Study Managers
- Clinical Program Managers/Program Directors
- Clinical Operations or Clinical Research Directors
- Clinical Research Associates/Site Monitors
- Quality Assurance/Clinical Quality Assurance
- Regulatory Manager/Associates
- Site Start-Up Specialists/Site Managers
Course Provider
Tina D Forrister,
