The following table describes the data elements displayed in the CTRO Daily Override Flag report for each trial:
| Data Element | Description |
|---|---|
| NCI ID | The unique ID assigned to the trial by the CTRP. |
| DCP ID | The unique ID assigned to the trial submitted by DCP (Division of Cancer Prevention). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
| CTEP ID | The unique ID assigned to the trial submitted by CTEP (Cancer Therapy Evaluation Program). For more information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
| Lead Organization | The name of the organization responsible for the trial's research protocol, and responsible for the overall scientific and administrative coordination, study monitoring, and data management activities of the trial. For more information, refer to Abstracting Sponsors and Responsible Parties. |
| Sponsor | The name of the primary organization that oversees the implementation of the study and is responsible for data analysis, as defined in 21 CFR 50.3. For more information, refer to Abstracting Sponsors and Responsible Parties. |
| Send Trial Information to ClinicalTrials.gov | A value telling the system whether to send the trial information to ClinicalTrials.gov in the automated nightly batch updates (via FTP):
For more information, refer to Abstracting NCI-Specific Information. |
| Completion Date | The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated. For more information, refer to Abstracting Trial Statuses. |
| Processing Status | The current status of the trial in the CTRP trial processing work flow. For information, refer to Trial Processing Statuses and Abstracting Trial Statuses. |
| Current Trial Status | The current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. For details, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Abstracting Trial Statuses. |
| Primary Completion Date | The date that the final subject was (or will be) examined or received (or will receive) an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated (as specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial). For more information, refer to Abstracting Trial Statuses. |
| Primary Completion Type | A value indicating whether the completion date is the one on which the trial is expected to complete (Anticipated), or the date on which it actually completed (Actual). For more information, refer to Abstracting Trial Statuses. |
| Section 801 Indicator | A value indicating whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801. For more information, refer to Abstracting Regulatory Information. |
| Processing Comments | Any comments that an abstractor has recorded for this trial. An abstractor can add comments on the Dashboard Details page or the Trial Identification page. For more information, refer to Tracking and Managing Trial Records or Viewing Trial Identification Details. |
| CTRO Override Flag Comments | Any comments that an abstractor has recorded (with the "Send Trial Information to ClinicalTrials.gov?" value) for this trial. For more information, refer to Abstracting NCI-Specific Information. |
