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OEWG timeline for opening a trial to enrollment, for Phase 1, 1/2, and 2 LOIs: Target timeline : 210 days Absolute dead PowerPoint Presentation
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OEWG timeline for opening a trial to enrollment, for Phase 1, 1/2, and 2 LOIs: Target timeline : 210 days Absolute dead - PowerPoint PPT Presentation


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Phase 1, 1/2, and 2 LOIs OEWG Timeline. OEWG timeline for opening a trial to enrollment, for Phase 1, 1/2, and 2 LOIs: Target timeline : 210 days Absolute deadline : 450 days. Phase 1, 1/2, and 2 LOIs include the following: Unsolicited LOIs – phase 1, 1/2, and 2

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Phase 1, 1/2, and 2 LOIsOEWG Timeline

OEWG timeline for opening a trial to enrollment, for Phase 1, 1/2, and 2 LOIs:

Target timeline: 210 days

Absolute deadline: 450 days

  • Phase 1, 1/2, and 2 LOIs include the following:
    • Unsolicited LOIs – phase 1, 1/2, and 2
    • Mass-solicitation LOIs – phase 1, 1/2, and 2, including Cooperative Group mass-solicitation LOIs > 100 patients
    • Cooperative Group phase 1, 1/2, and 2 LOIs < 100 patients

LOI approval stage: 60 days (Day 1 – 60)

Protocol authoring stage: 60 days (Day 60 – 120)

Protocol approval and open to enrollment: 90 days (Day 120 – 210)

(Please see timeline flowchart on next slide.)

Version 3.0 01 Apr 2012

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Stage 1: LOI approval

Target = 60 days

Submission of the LOI (Letter of Intent) to the NCI

NCI Review and conference call with investigators

NCI approval and if needed, pharmaceutical collaborator approval

Stage 2: Protocol submission

Target = 60 days

NCI approval and if needed, pharmaceutical collaborator approval

Protocol submission to the NCI for review

Stage 3: Protocol Approval and Activation

Target = 90 days

Submission of the protocol to the NCI

NCI Review and conference call with investigators

Approval of the protocol document by the NCI

Site finalization: IRB approval, contract negotiations, FDA review, etc.

Final approval and activation of the trial

Target for opening trial to enrollment is 210 calendar days

Absolute deadline for opening trial to enrollment is 450 calendar days

Version 3.0 01 Apr 2012