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Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol

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(Free Press Release) , 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. Scheduled On :Thursday, June 12, 2014 at 13:00 Hrs mississauga, ON, Canada

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.

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.

Areas Covered in the Session :

The overall structure of a protocol and regulatory requirements

Identify who contributes to the protocol development and amendments

The element of a protocol such a background scientific rationale, design (single blind, double blind, randomized, etc.), primary and secondary endpoints, inclusion/exclusion criteria, the Schedule of Events, adverse event management, statistical parameters, informed consent, and study synopsis

Practical issues with protocol writing such a differences in various phases of clinical trials, the protocol review process, using key opinion leaders, and using public resources and templates

Common issues with FDA and IRB approval of clinical protocols.

Who Will Benefit:

Regulatory Affairs Professionals

Sponsors of INDs

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

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

 

$ 299

For bookings and more information contact

Compliance Trainings

 

5939 Candlebrook Ct,
Mississauga, ON L5V 2V5,
Canada
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Acceptable Clinical Trial Protocol




Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol

Source: Press Release

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