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Validation for special InForm forms and items

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:

  • Is used multiple times in a study, unless it was copied using Copy > Link.

    Note: You can use the Copy > Link option to reuse the DOV item in a study. However, an error occurs if you use the DOV item multiple times in a study event, even if you copied it using Copy > Link.

  • Was copied using the Copy > Link option and pasted onto a form in the same study event.
  • Has an incorrect item type.
  • Is not on the first form in a study event.
  • Is in a repeating section or form.
  • Is in a common form or a section of a common form.
  • Is in a section in a repeating study event.

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.

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