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Regulatory Presentations

Bullet Documentation of Pediatric Risk/Benefit Category - November 2005 Adobe PDF DocumentMicrosoft PowerPoint Document

Bullet Protocol Registration Adobe PDF DocumentMicrosoft PowerPoint Document

Bullet Site Specific Informed Consent Adobe PDF DocumentMicrosoft PowerPoint Document

Bullet Expedited Adverse Event Reporting
 
  • DAIDS EAE Reporting Training (August 2009)
    Focuses on reporting according to the DAIDS EAE Manual.
Microsoft PowerPoint Document

  • DAIDS Safety Workshop (August 2009)
    Presents a broader perspective of Safety Monitoring and specifically addresses clear, complete and accurate adverse event reporting.
Microsoft PowerPoint Document

Bullet Requirements for IBC and RAC Submission Adobe PDF DocumentMicrosoft PowerPoint Document

 

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