10 Steps to the Perfect Clinical Trial Protocol: FDA-Compliant Protocol Development

Date: December 9, 2024
Duration: 60 Minutes
Time: 12 PM EST

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:
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:

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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.