The following table describes the data elements displayed in the CTRP Trial Verification Date report for each trial:
Data Element | Description |
---|---|
NCI ID | The unique ID assigned to the trial by the CTRP. |
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. |
Lead Organization ID | The unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number. |
NCT ID | The unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678). |
CTEP/DCP ID | The unique ID assigned to the trial submitted by the CTEP (Cancer Therapy Evaluation Program) or the DCP (Division of Cancer Prevention). |
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. |
Primary Completion Date | 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). |
Primary Completion Date 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). |
Current Milestone | The last recorded milestone. Milestones indicate the progress of the trial along its processing life cycle. For details, refer to Milestone Definitions and Recording Rules. |
Milestone Date | The date on which the abstractor or system recorded the last/current milestone. |
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. |
Current Status Date | The date on which the current trial status became effective. |
Record Verification Date | date on which the abstracted data for the trial was last verified. ClinicalTrials.gov displays the verification date along with an organization name to indicate to the public whether the information is being kept current, particularly recruiting status and contact information. In CTRP, the last verified date is the most recent date on which the CTRO confirmed all of a clinical study's information in CTRP as accurate and current. |