DAIDS Pediatric Risk Requirements for Protocol Registration

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DAIDS Pediatric Risk Requirements for Protocol
Registration

• Linda A. Ehler, RN, MN
• Mark A. Mishkin, BA

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July 8, 2005 letter from DAIDS Office for Policy
and Clinical Research Operations
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Documentation of Pediatric Risk

• IRB/EC determination of risk for studies
  involving pediatric subjects
• Example
• 45 CFR 46.405
• or
• Greater than minimal risk but prospects of direct
  benefit to the subject

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Upcoming protocol Registration Training

• New Requirements for Protocol Registration
  Required Documentation of Risk/Benefit Category
• Monday, October 24, 2005
• 900 A.M. 1000 A.M.

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Overview of Upcoming Training

• Brief overview of OHRP regulations 45 CFR 46
  subpart D
• DAIDS required documentation for protocol
  registration
• Examples of IRB documentation
• Special cases
• Additional protocol registration guidance

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Contact Information

• Protocol Registration Office
• Phone [phone]
• Fax [phone] or 301-897-1701
• E-mail protocol_at_tech-res.com
• Website http//rcc.tech-res-intl.com/