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Pediatric Advisory Committee

December 9, 2008

BRIEFING INFORMATION

Protocol Documents

ASCT0631 Protocol (pdf)
Correspondence from the COG CIRB (pdf)

Parental Permission and Child Assent Documents

ASCT0631 Parental Permission Recipient (pdf)
ASCT0631 Parental Permission Sibling Donor (pdf)
ASCT0631 Donor Assent 7-11yo (pdf)
ASCT0631 Donor Assent 12-17yo (pdf)
ASCT0631 Recipient Assent 7-11yo (pdf)
ASCT0631 Recipient Assent 12-17yo (pdf)

IRB Review Documents

IRB Minutes July 2 2008 (pdf)
Stipulation Rebuttal Letter ASCT0631 (pdf)
IRB Minutes September 3, 2008 (pdf)
ASCT0631 - 407-55 Cover Letter Final October 1, 2008 (pdf)

DOCUMENTS SUBMITTED BY SPONSOR (NCI)

ASCT0631 Cover Letter NIH 11-18-2008 (pdf)
ASCT0631 Initial Review APM Letter (pdf)
ASCT0631 risk benefit appendix (pdf)
BIOETHICS consult jan 2006 G-CSF Study (pdf)
OHRP Response re Sibling Benefit 01-2006 (pdf)

SUPPORTING LITERATURE BIBLIOGRAPHY DOCUMENT

Supporting Literature Bibliography Document (pdf)

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