General information—field descriptions

Field/Control Name	Description
Report Type	Select a report type that determines the availability of fields relating to clinical studies and literature references. The Clinical Study report prompts for information relating to the study, and literature-based reports enable to select the journal and reference on which the case is based.
Country	Select the country where the adverse event occurred.
Initial Receipt Date	Enter the date your company became aware of the case. Oracle Argus Safety uses this date throughout all reports. This date can be changed only prior to regulatory report submission.
Central Receipt Date	Enter the date on which this information was received by Central Safety.
Medically Confirm	Specify whether the case was medically confirmed or not, by a healthcare professional.
Initial Justification	Enter the initial justification reason. The entry in this field is displayed as per the reason entered when the case is being booked in.
Amendments/Follow-ups	On sorting by follow-up received dates, the serial number still displays the order of entering the follow-ups. The follow-up information can be sorted by: Serial Number Follow-up Received Date Central Received Date Click the header to sort in ascending or descending order. By default, the sorting is in descending order of the Follow-up Received Date. You can add up to 500 enteries using the Add button.
Follow-up Received Date	To enter the date on which amendment or follow-up information was received by your company, click Add. You can select whether the case has significant follow-up information by confirming the message: Is this follow-up significant?. When sorting on follow-ups, by default, the dates are sorted in descending order.
Safety Received	Enter the date on which follow-up information was received by Central Safety. This field is disabled for an amendment and any prior data in this field is cleared.
Significant	Check this checkbox if the follow-up is significant.
Data Clean up	Check this checkbox to mark the follow-up as a Data Clean up version. This version is used in the Data Lock Point for Case Versioning in and System Reports. This field is disabled for an amendment and any prior data in this field is cleared.
Amendment	Specify if the case was updated without adding any new information. This checkbox is enabled irrespective of whether the Significant checkbox is checked.
Amendment/Follow-up Justification	Select a pre-defined justification for Amendment or Follow-up. Click the icon to view the standard justifications dialog box. The justification entered in the Amendment field is also populated in this field. You can select a pre-defined justification from this dialog box or enter a new justification.
Case Requires Follow-up	Check this checkbox if the case requires follow-up information.
Classification	Select up to 50 case classifications used to categorize a case. To enter additional case classifications, click Add. When the Classifications field is hidden, the classification section is hidden on the Case Form