Validation area
| Error or warning
|
All special forms (Screening, Enrollment, Patient Identification, and Study Completion)
| Error if:
- The study contains multiple instances of the form.
- The form contains multiple instances of any item.
- Required fields are not on the form.
- The form is marked as repeating or appears in a repeating study event.
- The Special Forms property is defined on a section that is on the form.
|
Screening and Patient Identification forms
| Error if:
- (For a Screening form only) The form is used in multiple study events.
- (For a Screening form only) The form contains a repeating section.
- (For a Patient Identification form only) The Patient Number and Initials items are included on the form and are not together in either a section or the top-level form.
- All items are not on the same section or form.
- The item types for special items are not correct.
Warning if the special items are on a non-special form.
|
Enrollment form
| Error if the:
- Form is used in multiple study events.
- Item types for special items are not correct.
- Form contains a repeating section.
Warning if the special items are on a non-special form.
|
Study Completion form
| - Error if all items are not in the same form.
- Warning if the special items are on a non-special form.
|
DOV item
| Error if the item:
|
Randomization item
| - Error if the item appears multiple times in a study.
- Error if the Patient Number and Randomization items are on the same section or form. If one item is on a section, the other item is allowed to be outside the section on the same form.
|
Patient Initials item
| Warning if the item has 4 characters.
|
Drop Out Reason item
| Error if the code for its codelist item has more than 47 characters.
|