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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.
Lesson 1: Background of CSR
Lesson 2: Preparations Before Writing a Clinical Study Report
Lesson 3: Types of CSR
Lesson 4: The Hints and Tips
Lesson 5: CSR Appendices and Essential Documents
Lesson 6: Contents of a CSR