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.
Added by complianceonlinecom on January 10, 2013