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Find out what the FDA expects from your next clinical trial with this comprehensive management report from FDAnews — How to Create and Structure a Data Monitoring Committee.

Order today, and you’ll effectively determine if and when a DMC is necessary, based on the six types of FDA-identified clinical trials “particularly relevant” to DMC use, including studies with:

• Unusually high safety concerns
• Invasive treatment administration procedures
• Fragile or vulnerable subject populations, such as children, the elderly, pregnant women and the terminally ill
• And more — includes large, long-duration and multicenter studies

Anticipate critical “sticking points” imposed by the latest FDA guidance, and successfully meet these challenges head on when you discover how to:

• Create firewalls that preserve:
  • Confidentiality
  • Data integrity
  • DMC independence
• Build your DMC from the ground up:
  • Select the right DMC members
  • Avoid potential conflicts of interest
  • Outline the powers a DMC should — and should not — have
• Positively interact with a DMC
• Properly determine who can prepare DMC data
• And more — highlights four tips for incorporating DMCs into SOPs and study design

Avoid costly approval delays! Odds are increasing that the FDA will review the DMC structure for your next clinical trial based on the finalized 2006 guidance — before it grants your IND or IDE for a particular study. How to Create and Structure a Data Monitoring Committee, click here to order.

Get 27 Years of FDA and NIH Guidance in This One-Stop Resource:
Nine Appendices Include FDA’s Finalized 2006 Clinical Trial DMC Guidance

Now you can access clinical trial data monitoring guidelines from both the FDA and NIH. How to Create and Structure a Data Monitoring Committee gives you:

• NIH Policy for Data and Safety Monitoring
• 45 CFR Part 46: Protection of Human Subjects
• National Cancer Institute’s Essential Elements of a Data and Safety Monitoring Plan — for NCI-funded clinical trials
• Nine separate appendices, including FDA’s 2006 finalized Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
• And more

Buy Now!
Don’t risk rejection of your IND/IDE applications — make sure your DMC is up and running according to the latest FDA guidance today! Click here and place your order now.

Available in your choice of print or PDF formats, you pay just $337 each.