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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.
Topics Covered:

At the end of this webinar, you would understand:
  • Key element of a clinical protocol (scientific rationale, design, endpoints, etc.)
  • Creating protocol team and SOPs
  • Using templates and other tools
  • Best practices for writing different components of the clinical protocol
  • Ways to assure stakeholder involvement
  • Practical issues with protocol writing and potential solutions
  • Strategies for the protocol review, using key opinion leaders
  • Ways to assure FDA and IRB approval of clinical protocols
Why should you attend:
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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: 
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The following individuals or disciplines will benefit from attending this Webinar:
  • Sponsors of INDs
  • Regulatory affairs professionals
  • Senior management executives (CEO, COO, CFO, etc)
  • Drug discovery and development professionals (R&D and CMC)
  • Clinical trial managers
  • Project Managers and Clinical trial specialists
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
Date: December 10, 2018
Time: 12PM-1PM
​Duration: 60 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com