Expert Insights Webinars

A clinical study report (CSR) is an essential building block of a clinical submission. The ICH and FDA provide guidance for the structure and content of CSRs and instances when an abbreviated or synoptic CSR format should be used in place of a full CSR format, depending on the role of the CSR in a submission. Thoughtful selection of the CSR format based on study attributes, along with tailoring the template to include the appropriate data will help create a regulatory-compliant CSR and a successful downstream submission.

Key Takeaways

• Relevant regulatory guidance for CSR format and content

• How to select a suitable CSR format based on study attributes

• Examples of templates to facilitate authoring a fit-for-purpose CSR

• How to tailor a CSR to fit submission needs and regulatory requirements

Who Will Benefit from Attending?

• Clinical Operations/Development Professionals

• Regulatory Affairs Professionals

• Medical Writers

Presenter

Dr. Michelle Reed is a Senior Medical Writer with over 10 years of medical writing and clinical research experience. At MMS, she is involved in the development and improvement process for CSR templates and successfully worked with a team of colleagues to test and implement the usage of MMS’ automated formatting tool, SmartStart Document Templates, to increase efficiencies in document formatting and QC. Dr. Reed holds a Ph.D. of Biomedical Sciences in Immunology as well as a Bachelor of Science in Biology.

Presenter

Nicole Rudolph is a Medical Writer with over 10 years of clinical research and regulatory industry experience. At MMS, she provides medical writing support for a variety of document types, including Clinical Study Reports, Protocol and Protocol Amendments, and Informed Consent Forms, among many others. In addition, she reviews blinded data tables, listings, and graphs for CSR writing, manages document revisions and performs clean reads. Nicole holds a BSc in Molecular Biology, Biotechnology, Genetics, and Biochemistry, as well as a BSc(Hons) in Chemical Pathology.

Presenter

Laura Alionte is a Senior Principal Medical Writer with over 15 years of clinical research and scientific and medical writing experience. She specializes in regulatory submission documents, including protocols, Phase 1-4 Clinical Study Reports, and white papers. At MMS, she has led or contributed to more than 50 Phase 1-4 CSR projects, including several pivotal Phase 3 CSRs. Laura holds a Bachelor of Science in Microbiology and Human Biology.

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