Mastering New Reporting Rules

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Mastering New Reporting Rules

After reading the 177 pages of “Final Rule for Clinical Trails Registration and Results Information” (and re-reading it), can you honestly say:

  • You are certain you’re submitting everything it calls for?
  • You are in compliance with all required timelines?
  • You understand what changes under the final regulations, and what remains the same? Mastering New Reporting Rules parses out the rules provisions, explaining who must report what — what information they must submit — what deadlines are — and what could happen if they miss the mark. You’ll get clear explanations of:

  • What has changed with enactment of the final rule

  • Best practices in complying with US clinical trial disclosure requirements

  • The four elements of an “applicable drug clinical trial,” according to the FDA

  • The enforcement landscape for — what can the FDA do regarding noncompliance and when could enforcement start

  • How to decipher the “voluntary submissions” provisions

  • How to navigate the provisions for “delayed submission” of results to Mastering New Reporting Rules provides you with the information you need to revamp your data submission programs to meet the new requirements.

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Table of Contents

  • Introduction
  • Defining “Applicable Trial” Under the Final Rule.
  • New Registration Elements
  • Results Submission Requirements
  • And More …

View the entire TOC

Who Will Benefit

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

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