Second CTEP Review
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Protocol Approval on Hold, IRB Submission, FDA Submission, Preparation for Protocol Activation, Final CTEP Approval, and Status Update Indicating Activation Second CTEP Review NCI Receipt of LOI 14 days 14 days 7 days Phase 1/Phase 2 Timeline: Unsolicited LOIs 16 days Day 1 – 60: LOI Approval 60 days Day 60 – 120: Protocol Development Day 120 – 210: Protocol Approval Consensus Evaluation If LOI is on Hold, Conference Call Resubmission of LOI and Final Consensus Evaluation 30 days 14 days LOI Approva l NCI Protocol Receipt CTEP Review with Comments Conference Call to Review Major Issues Resubmission of Protocol * * * Deadline for Protocol Activation is 540 days including “timeouts” * * * 25 days “Timeout” for industry approval and/or drug commitment “Timeout” for IRB & FDA review If LOI is Approved at Day 30 PI Writes and Submits Protocol using CTEP protocol template and Library of Materials WEEK 1 (Day 1) WEEK 5 (Day 30) WEEK 7 (Day 44) WEEK 9 (Day 60) WEEK 18 (Day 120) WEEK 9 - 18 (Day 60 – 120) WEEK 9 (Day 60) WEEK 22 (Day 150) WEEK 24 (Day 164) WEEK 30 (Day 210) WEEK 26 (Day 178) WEEK 27 (Day 185) Version 1.0 13 April 2010
description
Phase 1/Phase 2 Timeline: Unsolicited LOIs. Day 1 – 60: LOI Approval. NCI Receipt of LOI. Consensus Evaluation. Resubmission of LOI and Final Consensus Evaluation. If LOI is on Hold, Conference Call. WEEK 1 (Day 1). WEEK 5 (Day 30). WEEK 7 (Day 44). WEEK 9 (Day 60). 30 days. - PowerPoint PPT Presentation
Transcript of Second CTEP Review
Protocol Approval on Hold, IRB Submission, FDA Submission, Preparation for Protocol Activation,
Final CTEP Approval, and Status Update Indicating Activation
Second CTEPReview
NCI Receipt of LOI
14 days 14 days 7 days
Phase 1/Phase 2 Timeline: Unsolicited LOIs
16 days
Day 1 – 60: LOI Approval
60 days
Day 60 – 120: Protocol Development
Day 120 – 210: Protocol Approval
Consensus Evaluation
If LOI is on Hold, Conference Call
Resubmission of LOI and Final Consensus Evaluation
30 days 14 days
LOIApproval
NCI ProtocolReceipt
CTEP Review with Comments
Conference Call toReview Major
Issues
Resubmission of Protocol
* * * Deadline for Protocol Activation is 540 days including “timeouts” * * *
25 days
“Timeout” for industry approval
and/or drug commitment
“Timeout” for IRB & FDA
review
If LOI is Approved at Day 30
PI Writes and Submits Protocol using CTEP
protocol template and Library of Materials
WEEK 1(Day 1)
WEEK 5(Day 30)
WEEK 7(Day 44)
WEEK 9(Day 60)
WEEK 18(Day 120)
WEEK 9 - 18(Day 60 – 120)
WEEK 9(Day 60)
WEEK 22(Day 150)
WEEK 24(Day 164)
WEEK 30(Day 210)
WEEK 26(Day 178)
WEEK 27(Day 185)
Version 1.0 13 April 2010
