Initial case entry—fields descriptions

Field	Description
Initial Receipt Date	Enter the complete date on which your company became aware of the case. The Receipt Date cannot be entered as a partial date.
Central Receipt Date	Enter the date on which this information was received by Central Safety.
Country of Incidence	Select the country where the adverse event occurred. This may or may not be the reporter's or the patient's country of residence.
Report Type	Select the item that best describes the type of report. This determines the fields that are made available for entering case information. The report type also impacts duplicate search. For example, selecting Sponsored Trial makes the Study ID and Protocol ID fields available. The Administrator can adjust the information in this list.
Study ID(applicable to clinical trial cases only)	Click Select to choose the study ID from the Clinical Trial Selection dialog box.
Center ID (applicable to clinical trial cases only)	Click Select to choose the Center ID from the Clinical Trial Selection dialog box.
Initial Justification	The values of this field are configurable through the standard Justifications dialog box. This field is reflected in the General tab of the Case Form and is also available for duplicate searching for cases. Click the green dot to view and select justifications from the Justification dialog box.
Product Name as Reported	Enter the verbatim drug name. The field is free text and editable in case form. During book-in, if you leave the Product Name field blank and tab out, then the data entered in Product Name as Reported is copied into the mandatory Product Name field. The data entered in this field during book-in are availailable in this field. If the Product Name as Reported field is left blank, then the case form also displays it as blank. For a spontaneous case and a non-company study case: If you enter data in both the Product Name and Product Name as Reported fields, then both fields are editable and data is captured individually. When you enter a product name by either copying it from the Product Name as Reported field or you enter it manually, then the Product Name field is not overwritten with data from Product Name as Reported. For a sponsored trial case: After the study is populated, the Product Name as Reported becomes read only. For blinded and non-blinded study cases, the field is read only.
Product Name	If the adverse event(s) are associated with more than one product, each additional product can be added from the Case Form. Enter the most suspect product here. Click Select to search for a product from the Trade Name Product Lookup dialog box. Several items are automatically entered on the Case Form based on the product selected here. If you enter data in the Product Name as Reported field, then the Product Name field is automatically populated.
Generic Name	This field can be used to enter the generic name of the product. This field is automatically entered when a product is selected from the Trade Name Product Lookup dialog box.
Batch/Lot #	In this field, you can enter the batch or lot number in a free-text form to search for duplicate cases. The search is performed on the following case fields: Drug > Dosage Regimens > Batch / Lot # Device > Device Information > Lot Vaccine > Vaccine Information > Batch / Lot # Note: The Dose # field from Vaccine > Vaccine Information > Vaccine History is not included in the search.
Description as Reported	Enter a brief verbatim description from the reporter describing the event that is most clinically important in the case. The icon denotes that the event is encoded. Click the icon to populate the MedDRA hierarchy dialog box.
Onset Date/Time	Enter the date/time for the onset of adverse event symptoms.
ID	Enter the value to search for a Reporter Reference number, Case Reference, and Case number.
Journal and/or Title	These items are applicable to literature cases only. Click Select to choose a journal and/or title from the Literature Reference dialog box. The Administrator can adjust this list.