Signatures and the OutcomeLogix object hierarchy

• Signing—When you sign a patient, visit, form, or item, only that object becomes signed. For example, when you sign a visit, the status of the visit becomes Signed, but the status of the forms in the visit does not. Instead, the objects receive the status Signed at parent level.

  The design of your study determines whether objects with signed parent objects can be considered signed themselves.

  • If the study allows implicit signing of child objects by signing the parent object, any objects with the Signed at parent level status are considered signed.
  • If the study requires explicit signatures on all levels, any objects with the Signed at parent level status still need to be signed explicitly.
• Unsigning—When you unsign a visit, form, or item, any parent objects are unsigned as well. For example, if a visit and form are both signed and you unsign the form, the visit becomes unsigned.

  Unsigning does not affect objects on the same level. For example, if a visit and two of its forms are signed, unsigning one of the forms unsigns the visit but does not affect the status of the other form.

• Signature invalidation—A signature is invalidated if any data is changed in the signed object, and the status of the object becomes Unsigned. Any parent objects become Unsigned as well. For example, if the value of a signed item changes in a signed form and visit, the status of the item, form, and visit becomes Unsigned.