$147

Developing a Reviewer-Friendly and Submission-Ready Clinical Study Report (CSR)

Course
43 Lessons

This is a crash-course on CSR development - with real-world examples and discussion of current trends in CSR writing! This course covers CSR content, how to include information in a way to help your reviewer, best practices for development, how CSRs fit into the development process, and my tips and tricks from over 10 years of CSR writing. I am confident that this is the best CSR course out there!

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Objectives of the course

After completing this course, you will:

Understand the purpose of a CSR and when/why CSRs are written
Be equipped with tools that facilitate CSR development
Understand the structure of a CSR and how different common templates vary
Have a detailed perspective of what goes where within a CSR and how this may vary depending on your template
Be familiar with the standard process and best practices for CSR development
Be able to differentiate between different types of CSRs and when a synoptic or abbreviated CSR may be acceptable
Recognize how CSRs fit into the bigger picture of the development process and understand the role of the CSR relative to other clinical documents in a regulatory submission
Understand the industry trends in CSR development and how transparency has impacted the process

Welcome!

Lesson 1 - Welcome!.mp4

Lesson 2 - What is a CSR.mp4

Tools for Writing a CSR

Lesson 3 - Guidance Documents.mp4

E3_Guideline.pdf

E3-Structure-and-Content-of-Clinical-Study-Reports---Questions-and-Answers-(R1).pdf

core-reference-v1_0.pdf

Lesson 4 - Walk-through of ICH E3.mp4

Lesson 5 - CSR Templates.mp4

CSR_CoreBWE_v005.docx

Lesson 6 - Walk-through of the TransCelerate CSR Template.mp4

Lesson 7 - Style Guides.mp4

Lesson 8 - Software for Writing CSRs.mp4

Writing Effective CSRs

Lesson 9 - Keys to Effective Writing and Messaging.mp4

Lesson 10 - Additional Tips for Writing an Effective CSR.mp4

Data Disclosure and Transparency

Lesson 11 - Registration and Public Posting of Study Data.mp4

ICMJE Recommendations.pdf

CTIS Transparency Rules.pdf

Overview of CSR Structure and Content

Lesson 12 - CSR Structure - ICH E3 versus TransCelerate.mp4

Lesson 13 - Non-data Sections and Data Sections.mp4

Lesson 14 - Other Important CSR Components.mp4

CSR Sections in Detail

Lesson 15 - Administrative Components and Synopsis.mp4

Lesson 16 - Introduction and Study Objectives and Endpoints.mp4

Lesson 17 - Investigational Plan.mp4

Lesson 18 - Study Participants.mp4

Lesson 19 - Evaluation and Response to Study Intervention - Part 1.mp4

Lesson 20 - Evaluation and Response to Study Intervention - Part 2.mp4

Lesson 21 - Conclusions and References.mp4

Lesson 22 - Post-text Content.mp4

Types of CSRs

Lesson 23 -Types of CSRs.mp4

Submission-of-Abbreviated-Reports-and-Synopses-in-Support-of-Marketing-Applications.pdf

CSR Development Process

Lesson 24 - CSR Development Steps and Kick-off.mp4

Lesson 25 - CSR Authoring and Review.mp4

Lesson 26 - CSR QC, Publishing, and Approval.mp4

Lesson 27 - Example CSR Timeline.mp4

Lesson 28 - Collaborative Nature of CSR Development.mp4

Lesson 29 - Etiquette and Best Practices.mp4

How CSRs Fit into the Bigger Picture

Lesson 30 - The Many Documents Required in Drug Development.mp4

Lesson 31 - The Common Technical Document (CTD).mp4

ICH Guidance_Organization of the CTD.pdf

Lesson 32 - Clinical Data Documents in the CTD.mp4

M4E(R2) CTD Clinical Documents.pdf

Lesson 33 - Messaging Across Clinical Documents.mp4

Summary

Lesson 34 - Final Tips for Success.mp4