How to Avoid Protocol Deviations at Development and Execution Phase of a Global Clinical Trial
Thursday, January 17, 2013 from 9:00 AM to 10:00 AM (PST)
Palo Alto, CA
This webinar on avoiding protocol deviations in global clinical trials will focus on the key items to consider in developing a clinical study protocol, that accommodates the country specific needs, and how to equip the global operational team to manage a successful clinical trial.
Why Should You Attend:
When a locally developed study protocol is to be implemented globally, you need to take into consideration many variations around regulations, cultural background and training levels of research staff across, and various other environmental factors in subject countries. Will regulatory authorities reject the data generated due to protocol deviations? Will a sponsor loose all the cost and time spent on a trial that may fail to achieve its objectives due to protocol deviations?
This webinar will provide practical tips to keep a study protocol simple and flexible to the extent possible so the protocol deviations are manageable and the sponsor will be able to achieve the business objective of running a clinical trial in a global environment. At the end of this session, you would have the inputs needed to develop a scientifically sound and ethically compliant study protocol that accommodates the country specific needs and provides flexibility wherever possible.
Areas Covered in the Webinar:
- Understanding the global environment for clinical research
- Essential components of a Clinical Study Protocol Development
- Things to consider in developing a study protocol for a global clinical trial
- Rolling out an approved study protocol to outside US regulatory authorities
- Developing a successful Protocol Training Plan for the research staff
- Monitoring the partners/ CROs
- Developing a Protocol Deviation Management Plan
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.