Menu Back to Course-2-TMP-Metrics-Measuring-Regulated-Content


Short Course* Registration: 7:30AM-12:00PM

An MCC working group is developing metrics to assess the health of the Trial Master File. The team has developed standard metrics to monitor the health of the Trial Master File by measuring quality, timeliness, and completeness at defined milestones and events. These metrics will apply whether the documents are stored in an electronic content management system or in paper with an electronic index for the documents.

*Short Courses are not included in the forum registration and require a separate fee.

Return to Regulatory Submissions, Information, and Document Management Forum

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Interpret the MCC metric plans for quality and timeliness
  • Describe the events and milestones associated with a clinical trial
  • Explain the MCC TMF Mapping tool’s relationship to the TMF Reference Model