Program Overview
This is an advanced, practice-oriented program tailored for regulatory and medical writers who need to produce high-quality Clinical Study Reports (CSRs) that withstand sponsor and regulatory scrutiny. Going beyond templates and structure, the course emphasizes data interpretation, integrating tables/figures/listings (TFLs), applying QC and audit-readiness standards, and collaborating with cross-functional stakeholders. Participants gain hands-on experience through simulations, annotated templates, and peer-reviewed exercises, enabling them to confidently transform raw clinical data into clear, compliant, and submission-ready narratives aligned with EMA/FDA expectations.
Features
- Apply ICH E3 and global regulatory guidelines to structure compliant CSRs
- Interpret TFLs effectively and integrate insights into narrative sections
- Ensure submission-readiness through QC, audit-proofing, and checklists
- Collaborate across clinical, statistical, and pharmacovigilance functions for efficient CSR development
Target audiences
- Regulatory writers and QC reviewers specializing in CSRs
- Medical writers focusing on Phase II–IV submissions
- Clinical research professionals transitioning into writing roles
Curriculum
- 7 Sections
- 19 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- Introduction to CSR Writing3
- Anatomy of a CSR2
- Data Interpretation and TFL Integration3
- Practical Writing Techniques3
- Collaboration and Review Process3
- QC, Submission Readiness, and Compliance3
- Hands-on Simulation2
Instructor
