New Resource: eTMF and Email Presentation

April 7, 2016

  • eTMF Resources

Wingspan’s slides about eTMF and email are now available for download. In this presentation, Kathie Clark outlines the guidance provided by the MHRA and EMA about documenting correspondence in eTMF. She uses two case studies to demonstrate how correspondence varies between trials and organizations.

For example, in Case Study 1, Safety Report Cover Letters represent more than half of all correspondence in the eTMF.