Study information—field descriptions

Field/Control Name	Description
Project ID	Enter the Project ID, or select one from the list. Selecting a Project ID automatically creates items in the Study ID list.
Study Phase	Enter the Study Phase for the configured study. This field is pre-populated if you select a Study with an already-configured Study Phase.
Blinding Status	The status is auto-populated based on the type of study. You need special access rights to use any of the Broken By entries. Note: The Unblind Case dialog box appears when you try to unblind a study. For Not Blinded studies, saving the case or generating a report, you can enter the actual drug (vs. placebo) given to the patient.
Observe Study Type	The value selected from this drop-down list is populated in the Case Form Study Section when the Clinical Study is selected.
Unblinding Date	Auto-populates when the blinding status is changed to Broken by Sponsor or Broken by Investigator. If you double-click the date in this item, the Unblind Case dialog box is displayed. If the date of unblinding is more recent than the date for the most significant follow-up information, an automatic follow-up is generated. The unblinded date is not editable in the Unblind Case dialog box when blinded status is changed to Broken by Sponsor whereas it is editable when the blinded status is changed to Broken by Investigator.