Trial status refers to the current stage or state of participant/patient enrollment in a clinical trial relative to other stages. CTRP uses the same statuses at the trial level and at the participating site level. The following table lists the valid Expanded Access trial statuses used in CTRP and in ClinicalTrials.gov. For information on other trial statuses used in CTRP and in ClinicalTrials.gov, refer to Trial Status Values in the CTRP and ClinicalTrials.gov.
Current trial status definitions
# | Trial Status Values | Status Category | Definition |
---|---|---|---|
1 | Available | Open | Expanded access is currently available. |
2 | No longer available | Terminal | Expanded access was available previously but is not currently available and is not expected to be available in the future. |
3 | Temporarily not available | Open | Expanded access was previously available, is not currently available, but is expected to be available in the future. |
4 | Approved for marketing | Terminal | Expanded access was available previously, but is not currently available because the product has been approved, licensed, or cleared by the U.S. Food and Drug Administration. |