Glossary of Terms - National Cancer Institute
Glossary of Terms
CTEP Operational Efficiency Working Group (OEWG)
Version date: April 1, 2012
Absolute Deadline – Time, in calendar days, INCLUDING time-outs, by which a trial must be open to patient enrollment. Trials that are not open to patient enrollment by the Absolute Deadline will be automatically terminated.
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 are resolved.
Open to enrollment/ “Patient ready” – Trial is ready to enroll a patient and at least one site has IRB approval.
Protocol activation: Trial opens to enrollment – i.e., it is “patient ready” (please see the definition, above, of “Open to enrollment/ ‘Patient ready’”).
Protocol approval – Protocol document is acceptable to the NCI and all NCI regulatory/logistical issues have been resolved, including IRB approval for Non-Group trials. Cooperative Group studies do NOT require IRB approval until protocol activation.
Target Timeline – Time, in calendar days, by which it is optimal for the trial to be opened to patient enrollment.
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