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.

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download