Validating Trial Status - Include 20170822

Validate the trial status for Complete trials only.

Trial Status validation does not pertain to Abbreviated trials.

Ensure that the relationships between statuses and dates follow the rules provided in Status Transition Rules and the tables and diagrams that follow.

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 trial statuses used in CTRP and maps each value to the corresponding ClinicalTrials.gov-defined recruitment value.

For information on Expanded Access trial statuses, refer to Expanded Access Statuses.

Current trial status definitions

#	CTRP Trial Status Values	ClinicalTrials.gov Trial Status Values	Status Category	Definition
01	In Review	Not yet recruiting	Review	Participants are not yet being recruited.
11	Withdrawn	Withdrawn	Terminal	Study halted prematurely, prior to enrollment of first participant.
02	Approved	Not yet recruiting	Review	Participants are not yet being recruited.
03	Active	Recruiting	Open	Participants are currently being recruited, whether or not any participants have yet been enrolled.
04	Enrolling by Invitation	Enrolling by Invitation	Open	Participants are being (or will be) selected from a predetermined population.
08	Temporarily Closed to Accrual	Suspended	Open	Study halted prematurely but potentially will resume.
09	Temporarily Closed to Accrual and Intervention	Suspended	Open	Study halted prematurely but potentially will resume.
05	Closed to Accrual	Active, not recruiting	Closed	Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled.
06	Closed to Accrual and Intervention	Active, not recruiting	Closed	Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled.
10	Administratively Complete	Terminated	Terminal	Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
07	Complete	Completed	Terminal	The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred).

If you transition from this status...	To this status...	The system creates this status
In Review	Active, or Enrolling by Invitation	Approved
Active, or Enrolling by Invitation	Closed to Accrual and Intervention	Closed to Accrual
Active, or Enrolling by Invitation	Completed	Closed to Accrual Closed to Accrual and Intervention
Temporarily Closed to Accrual	Administratively Completed	Temporarily Closed to Accrual and Intervention
Temporarily Closed to Accrual	Closed to Accrual	None
Temporarily Closed to Accrual	Closed to Accrual and Intervention	None
Temporarily Closed to Accrual and Intervention	Closed to Accrual	None
Temporarily Closed to Accrual and Intervention	Closed to Accrual and Intervention	None

How to Review Trial Status Details

Select a trial to validate by following the instructions in Selecting Trials that Require Validation. The Trial Identification page displays the trial details.
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.)
On the Validation menu, click Trial Status. The Trial Status page appears.
To view trial status information previously recorded, in the upper right corner of the Trial Status section, click History.

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 a list of valid values, refer to Trial Status Values in the CTRP and ClinicalTrials.gov.
Current Trial Status Date*	Enter the date on which the current trial status became effective.
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.

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.

Indicate whether each date you entered is Actual or Anticipated, according to the rules specified in Status Rules for Trial Dates.
If you made any changes, click Save.
If the system displays errors and/or warnings, correct them according to the instructions in Abstracting Trial Status Histories.

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