FDAnews Announces — New Management Report — ClinicalTrials.gov: Mastering New Reporting Rules

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42 CFR Part 11, “Final Rule for Clinical Trials Registration and Results Information,” is confusing. ClinicalTrials.gov: Mastering New Reporting Rules parses out the rule’s provisions, explaining who must report what, what information must be submitted, what the deadlines are and what could happen if the mark is missed.

ClinicalTrials.gov:
Mastering New Reporting Rules
**An FDAnews Management Report**
http://www.fdanews.com/products/54887-clinicaltrialsgov        

42 CFR Part 11, “Final Rule for Clinical Trials Registration and Results Information,” is confusing. This new final rule is full of changes large and small.

ClinicalTrials.gov: Mastering New Reporting Rules parses out the rule’s provisions, explaining who must report what, what information must be submitted, what the deadlines are and what could happen if the mark is missed. Readers will 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 readers with the information they need to revamp data submission programs to meet the new requirements.

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

FDAnews Management Report Details:
ClinicalTrials.gov:
Mastering New Reporting Rules
Price: $397
http://www.fdanews.com/products/54887-clinicaltrialsgov    

Easy Ways to Order:
Online: http://www.fdanews.com/products/54887-clinicaltrialsgov            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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