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 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 Study Completion Date types.
The following table provides the rules for trial status dates as diagrammed.
Rules for Status/Dates relationships
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Current Trial Status is anything other than In Review, Approved, or Withdrawn | Trial Start Date must be Actual (solid band) |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 actual.
- If the date is today, the type could be actual or anticipated.
- If the date is in the future, the type must always be anticipated.
The general rules for Study Date values are as follows:
- 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
The Primary Completion Date can be earlier than the Current Trial Status Dates Complete or Administratively Complete if the Primary Completion Date is Actual
The Completion Date is always the same as, or later than, the Primary Completion Date
