ClinicalTrials.gov: Mastering New Reporting Rules

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ClinicalTrials.gov
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?

ClinicalTrials.gov: 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 ClinicalTrials.gov — what can the FDA do regarding noncompliance and when could enforcement start

  • How to decipher the ClinicalTrials.gov “voluntary submissions” provisions

  • How to navigate the provisions for “delayed submission” of results to ClinicalTrials.gov

ClinicalTrials.gov: 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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