How to Create Fit-For-Purpose Clinical Study Reports for Successful Submissions
June 15, 2022 - MI USMMS Holdings
azimmerman@mmsholdings.com
Phone:734-738-5055
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. 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