NIH | National Cancer Institute | NCI Wiki  

The system does not change the status of participating sites when you close a trial.

How to Abstract Trial Status Information

  1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

  2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

  3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

  4. On the Administrative Data menu, click Trial Status. The Trial Status page appears.

  5. In the various status fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Field Label

    Description/Instructions

    Current Trial Status*

    Select the trial’s accrual status from the drop-down list. For valid ClinicalTrials.gov recruitment values, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Expanded Access Statuses.

    Current Trial Status Date*

    Enter the date on which the current trial status became effective. For information, refer to CTRP System Rules for Study Status and Dates.

    Why Study Stopped

    If you selected the Administratively Complete, Withdrawn, or Temporarily Closed to Accrual status, type the reason why the study has ended or is not currently accruing. You can update your comment only for trials that are Temporarily Closed to Accrual. Optionally, enter any comments regarding the trial status.  


     

  6. In the various date fields, specify dates as they occur according to the rules specified in CTRP System Rules for Study Status and Dates. The following table describes the fields. In this table, an asterisk (*) indicates a required field and an asterisk within square brackets ([*]) indicates a conditionally required field.

    Field Label

    Description/Instructions

    Trial Start Date*

    Enter the date on which the trial started, or is expected to start.

    Primary Completion Date [*]

    Enter the date on which the final subject was examined or received an intervention, or the date on which that is expected to happen.

    Primary Completion Dates are optional in the following cases:

    • For non-interventional trials.

    • For DCP trials, if you select N/A as the type.

    In both cases, the system excludes such trials when submitting XML documents to ClinicalTrials.gov. Otherwise, Primary Completion Dates are required.

    Completion Date

    Enter the final date on which data was (or is expected to be) collected for the trial.

  7. Indicate whether each date you entered is Actual or Anticipated, according to the rules specified in Status Rules for Trial Dates.
  8. Click Save

  9. If the system displays warning and/or error messages, click the History icon, and follow the instructions in Abstracting Trial Status Histories to correct them.