Management of Clinical Study Reports

Clinical Study Reports (CSRs) provide a detailed description of the entire clinical study process. Proper documentation is required as it will be requested for marketing authorization. Essentially, the authorities concerned want to see that the substance or device can fill a need that has not already been filled and is safe for use in humans. A thoroughly compiled CSR will include charts, tables, diagrams, methods, discussions, conclusions, and many more segments.

This course exposes you to the proper structure of a CSR and intimates you on the ICH guidelines for compiling a complete CSR. Proper documentation is important for clinical studies as these documents must provide sufficient answers to questions that may arise from a review of the study.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: Background of CSR

Lesson 2: Preparations Before Writing a Clinical Study Report

• The Protocol/Methodology of the Trail
• The Disease Process
• The Investigator Brochure (IB)
• The Case Report Forms (CRFs)
• SOPs or Other Instructional Materials
• The Statistical Analysis Plan (SAP)
• The Tables, Listings, and Figures (TLFs)

Lesson 3: Types of CSR

• Type 1: Full CSRs
• Type 2: Supplemental CSR
• Type 3: Abbreviated CSR
• Type 4: Synoptic CSR

Lesson 4: The Hints and Tips

• Start Quickly
• Start from Where
• Management of the Project
• Discuss and Support
• Conclusion
• Appendices

Lesson 5: CSR Appendices and Essential Documents

Lesson 6: Contents of a CSR

• Introductory Sections
• Methods
• Study Subjects
• Efficacy
• Safety
• Conclusions

Glossary

Conclusion