Day 210

1
Group Phase 3 Timeline Steering Committee
Evaluation
Day 1 90 Concept Approval
Due Date for Concept Receipt for Disease
Steering Committee
Call with SC Co-Chairs CIB
Steering Committee (SC) Review
Submission of Revised Concept
SC Meeting
SC Meeting
Preparation of Revised Concept
SC Review of Revised Concept
Consensus Evaluation
Investigators Review of CE
Day 50
Day 1
Day 22
Day 83
Day 76
Day 36
14 days (Group review CE Call scheduled if
Concept pending for questions)
7 days
21 days (Selection SC reviewers review
preparation)
14 days (Vote ,Consensus Evaluation (CE)
Preparation, SC Review)
26 days
2nd Consensus Evaluation
7 days (Vote, Final CE preparation, SC Review)
Day 90 180 Protocol Development
Concept Approval
Team Set-Up Conference Call
NCI Protocol Receipt
Day 180
Day 104
Day 90
Group writes protocol (If study under CTEP IND,
CTEP provides appropriate template information
Library of Materials)
Timeout for industry approval and/or drug
Commitment FDA review for licensing trial
14 days (from approval for Group CTEP to map
out joint timeline)
90 days
30 days
Day 180 300 Protocol Approval
Protocol Approval on Hold, IRB Submission,
Preparation of Protocol Activation, Final CTEP
Approval, and Status Update Indicating Activation
Conference Call To Review Major Issues
Group Resubmission 2nd CTEP Review
CTEP Review with Comments
Day 224
Day 210
Day 300
Day 254
ONE REVISION
Possible timeout for IRB Review (or FDA
review if under FDA SPA)
Deadline for Protocol Activation is 730
days including timeouts
Version 1.0 13 April 2010