$147

Writing an Effective Clinical Trial Protocol

Course
48 Lessons

Learn how to craft clear, compliant, and effective clinical trial protocols with this comprehensive course. This course is designed for clinical researchers, medical writers, and healthcare professionals who want to master the essentials of protocol development. You’ll gain a deep understanding of the purpose and goals of a well-structured protocol and uncover best practices for writing with precision and clarity. This course also covers tools to streamline protocol creation, tips for successful development, and guidance on protocol amendments. By the end, you'll be better equipped to confidently develop protocols that meet both scientific and regulatory standards, enhancing the success of your clinical trials.

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Objectives of the course

After completing this course, you will effectively:

Understand the purpose and goals of an effective clinical trial protocol
Recognize how other clinical documents are related to protocols
Apply best practices for effective protocol writing
Leverage tools that facilitate protocol development
Evaluate and consider important study design details
Construct comprehensive protocols with the right structure, content, and level of detail
Navigate the protocol development process with proven strategies for success
Implement effective strategies for amending protocols when necessary
Comply with regulations on clinical trial transparency and disclosure to enhance clinical trial activities

Introduction

Welcome.mp4

Course Objectives.mp4

Acronyms and Abbreviations Used in this Course.docx

Defining the Protocol and Related Documents

What is a Protocol.mp4

Documents Related to the Protocol.mp4

Writing Effective Protocols

Effective Protocol Writing - Part 1.mp4

Effective Protocol Writing - Part 2.mp4

Tools for Writing a Protocol

Guidance Documents.mp4

ICH E6_R3.pdf

Walk-through of ICH E6_R3.mp4

GCP-ISO 14155 Checklist for Device Protocols.docx

EU CTR 536-2014.pdf

Templates and Style Guides.mp4

Walk-through of the TransCelerate Protocol Template.mp4

TransCelerate Protocol Template_v010.docx

Software for Protocol Writing.mp4

Basics of Study Design

Study Phases.mp4

Key Features of Study Design - Part 1.mp4

Key Features of Study Design - Part 2.mp4

How to Choose the Best Study Design.mp4

Protocol Structure and Content

Protocol Structure and Content.mp4

Protocol Sections in Detail

Administrative Components.mp4

Synopsis and Schema.mp4

Schedule of Activities.mp4

Introduction.mp4

Objectives, Endpoints, and Estimands.mp4

ICH E9 (R1).pdf

Study Design.mp4

Study Population.mp4

Study Intervention, Withdrawl, and Discontinuation.mp4

Study Assessments and Procedures.mp4

Statistical Considerations.mp4

Supporting Documentation - Part 1.mp4

Supporting Documentation - Part 2.mp4

Protocol Development Process

Initiating the Protocol.mp4

Authoring and Reviewing the Protocol.mp4

The Importance of Quality Control.mp4

Publishing and Document Approval.mp4

Example Timeline.mp4

The Collaborative Process of Protocol Development.mp4

Collaborative Authoring and Review Best Practices.mp4

Protocol Amendments

Protocol Amendments - What, When, and Why.mp4

How to Amend a Protocol and Best Practices.mp4

Clinical Trial Transparency and Disclosure

Why Clinical Trials Should be Registered.mp4

42 CFR Part 11.pdf

ICMJE Recommendations.pdf

Considerations for Registration.mp4

Course Wrap-Up

Final Tips and Take-home Messages.mp4