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New Approaches to Submission Components
Session Chair(s)
Janet K. Stoltenborg, MBA, MS
Global Head, Medical Communications Science
Astrazeneca Pharmaceuticals LP, United States
The world of clinical trial reporting continues to evolve with increasing requests for information and the ever-present need to be more efficient in delivery. This symposium provides the medical writer with new approaches to streamline clinical study reporting while meeting new transparency requirements.
Learning Objective : Describe the basic process for a clinical study report appendix compilation including how to streamline the process; Discuss why and how to capture clinical study data elements for incorporation into regulatory documents; Identify with the new clinical trial transparency requirements for clinical reports, how to implement processes to protect privacy while being transparent with clinical trial information.
Speaker(s)
Ready, Set, Go! Initiating the New Clinical Report Redaction
Janet K. Stoltenborg, MBA, MS
Astrazeneca Pharmaceuticals LP, United States
Global Head, Medical Communications Science
CAPITALize Your Time and Efficiency: Streamlining Appendices Compilation
Carrie McKenzie
WebbWrites, LLC, United States
Director, Project Management
Web-based Tool for the Programmatic Generation of Tabular Listings of Clinical Studies for Regulatory Documents
Jennifer Seamon
Janssen Research & Development, LLC, United States
Principal Medical Writing Scientist
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