Special Considerations for Pediatric Trials


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Clinical research with minors poses several significantly different issues than research conducted on adults. Therefore, researchers must address a number of special considerations when conducting any pediatric clinical trial.

Topics

  • Definitions
  • Evaluating the risks and benefits of the study
  • Parental permission and assent of the study

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Provided by Advarra

Advarra provides institutional review board (IRB), institutional biosafety committee (IBC) and global research compliance services to clinical trial sponsors, CROs, hospital systems, academic medical centers and investigators. Its robust regulatory expertise and innovative technology ensure the highest standards of research review are met, while putting participants first and meeting complex human research protection oversight requirements.