Glossary of Terms
Glossary of Terms
Approval on Hold – The document has received CTEP scientific approval and is “approved on hold.” To achieve protocol approval status, the following checklist items must be completed: receipt of local IRB approval for Non-Group studies, protocol sent to FDA (when applicable), all investigator registration issues resolved, all agent availability/supply issues have been resolved, Case Report Forms are Common Data Element (CDE) compliant (phase 3 trials only), and all other trial and agent specific issues.
Protocol Approval – Protocol document is acceptable to the NCI and all NCI regulatory/logistical issues have been met, including IRB approval for Non-Group trials. Group studies do NOT require IRB approval until protocol activation.
Protocol Activation – Protocol is ready for patient accrual (Protocol approved, CRFs complete; database ready; contracts signed; any correlative science issues resolved; IRB approval has been gained)
Target Timeline – Time, in calendar days, required to reach major protocol development objectives
Time-Out – Time -clock stops for issues outside of NCI’s or PI’s purview (i.e. Pharma approval, IRB review). Time-out time is NOT counted towards Target Milestones however, it IS counted toward the absolute deadline
Absolute Deadline – Last date, in calendar days, for protocol to be activated including Time-Outs. Trials that are not Activated by the Absolute Deadline will be automatically disapproved.
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