How to Create Fit-For-Purpose Clinical Study Reports for Successful Submissions

What You Will Learn

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.

Attendees will learn about:

• 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