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Comment: Revised based on review feedback from Michael Izbicki.

Valid dates for a given trial status depend on the other values you have entered, and whether those dates are Actual (current, or past) or Anticipated (future).
The following diagram table illustrates these rules. The arrow at the top of the diagram represents a time line for the life of a trial. The three horizontal bands in the lower section of the diagram represent, from top to bottom, the relative date (actual or anticipated) rules for trial Start Date types, Primary Completion Date types, and Completion Date types. Anchor69306930

Diagram showing the links between anticipated and actual trial status dates as described in the textImage Removed

The following table provides the rules for trial status dates as diagrammed.

Rules for Status/Dates relationships

:

StatusStart Date TypePrimary Completion Date TypeCompletion Date Type
  • In Review
  • Approved
  • Withdrawn
  • Active
  • Enrolling by Invitation
Can be Actual or Anticipated.Can be Actual or Anticipated.Must be Anticipated.
  • Temporarily Closed to Accrual
  • Temporarily Closed to Accrual and Intervention
  • Closed to Accrual
  • Closed to Accrual and Intervention
Must be Actual.Can be Actual or Anticipated.Can be Actual or Anticipated.
  • Complete
  • Administratively Complete
Must be Actual.Must be Actual.Can be Actual or Anticipated.

If this is true...

Follow this rule

Current Trial Status is anything other than In Review, Approved, or Withdrawn

Trial Start Date must be Actual (solid band)

Current Trial Status is Approved or In Review

Trial Start Date could be Actual or Anticipated (diagonal stripes band)

Current Trial Status is Complete

All date types must be Actual (solid band)

The general rules for Study Date types are as follows:

  • If the date is in the past, the type must be actualActual.
  • If the date is today, the type could be actual Actual or anticipatedAnticipated.
  • If the date is in the future, the type must always be anticipatedAnticipated.

The general rules for Study Date values are as follows: Anchor61766176

  • The Trial Start Date can be in the past, present, or future.

  • The Primary Completion Date is always the same as, or later than, the Trial Start Date.

  • If the Primary Completion Date is Actual, it can be earlier than the Current Trial Status Dates Complete or Administratively Complete.

  • The Completion Date is always the same as, or later than, the Primary Completion Date.

...