OHSU Knight Cancer Institute

CTRP & CCSG Panel for CI4CC

Presented by: Shannon McWeeney, PhD mcweeney@ohsu.edu

Date: February 22nd, 2013

2 “Staff with responsibilities relevant to data submissions for the

NCI Clinical Trials Reporting Program.”

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OHSU Knight Cancer Institute

• CTRP supplement

– Revision of SOPs, Protocol Templates,

Checklists and workflows

– Internal valdiation, Auditing and Compliance,

– Communication with NCI CTRO and CT.GOV

– Training, Education and Follow-up (Resource

for Investigators and Study Coordinators)

– Embedded in BISR and KCTO (jointly)

– 1.0 FTE

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Learning & Validation from Common Protocol Errors

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On the horizon

• Predicted sunset of CTRP supplement

• Changing landscape of requirements and

coordination (CT.GOV and CTRP)

• Evolving Coordination between CTRP and

NCI CC Program re Summary 4

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