Complianz World, a US based company, is a leading GRC training provider, brings a range of topics related to compliance, delivered through webinars by industry experts. It has announced to launch Webinar on 10 Steps to an FDA-Acceptable Clinical Trial Protocol
The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. 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. Per FDA and ICH guidelines, a clinical protocol should be based on sound scientific rationale, conducted in a suitable population, include all appropriate procedures that help meet the endpoints, and be protective of study participants both physically and ethically.
On an average about one of every three clinical trials fail to meet their primary goals due to poor design, faulty statistical strategy, lower recruitment, poor management of resources, 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 critical 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.
Course Objective:
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.
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Complianz World offers Online Regulatory Compliance Training, Webinar & Seminar on Pharmaceuticals , Biotechnology , Medical Devices ,FDA Compliance , Clinical Research , Laboratory Compliance , Healthcare Compliance , Banking and Financial Services (BFSI) , Human Resources (HR) , OSHA , Trade and Logistics , GRC Regulations compliance training by expert speakers
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