Webinars >>Clinical Trials Protocal
10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development
The clinical trial protocol is a multi-dimensional document that is governed by several FDA requirements and practical considerations. While there are several templates available online for clinical protocols, including one from FDA, there are many schools of thought about the best approach to writing a clinical trial protocol. Depending on individuals or organizations sponsoring a given clinical trial, diverse processes are followed to create clinical trial protocols. BY some accounts, about two-thirds of clinical trials fail to meet their primary goals due to poor design, faulty statistical strategy, unrealistic operational requirements, lack of involvement of all stakeholders, and regulatory issues. Most of these causes of failure can be mitigated by a well-designed clinical trial protocol. Irrespective of the Phase of a study, clinical trial protocols should follow some common rules. These rules are based on regulatory requirements, scientific logic, and practical experience. This seminar will walk the attendee through 10 steps in the development of a clinical protocol. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions.
At the end of this webinar, you would understand:
Why should you attend:
If you are involved in writing a clinical trial protocol, this seminar will provide valuable suggestions about various aspects of a clinical protocol from initial synopsis to various elements of the protocol, role of various personnel in finalizing the protocol, and troubleshooting common issues. The basic elements of a clinical trial protocol, the dos and don’ts of clinical trial procedures, development of a new protocol, amending protocols, scientific and ethical review of clinical protocols will be discussed. Also discussed will be role of interactions with the FDA, global clinical trials, and projected trends for the near future.
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: email@example.com