STUDY DOCUMENTS

• Study Protocol [.pdf]
  Note: Chapter 14 of the Protocol includes all policies for Ancillary Studies
• Informed Consent Form for Participation on the Study (Template) [.doc]
• Child Assent Form for Participation in the Study (Template) [.doc]
• Consent Form for Stored Materials – Adult (Template) [.doc]
• Consent Form for Stored Materials – Child 13-17 (Template) [.doc]
• Consent Form for Stored Materials - Parent (Template) [.doc]
• FDA Certificate of Confidentiality [.pdf]
• Health Canada No Objection Letter [.pdf]
• Study Power Point Presentation (updated after ASN 2003) [.ppt]
• Manual of Operations
• All Case Report Forms (CRFs)
• Form Instructions
• CRFs by Visit (B01 and FUP Breakdown)