This field is automatically entered when a product is selected from the Trade Name Product Lookup dialog box.Įnter a brief verbatim description from the reporter describing the event that is most clinically important in the case. This field can be used to enter the generic name of the product. Several items are automatically entered on the Case Form based on the product selected here. Click Select to search for a product from the Trade Name Product Lookup dialog box. If the adverse event(s) are associated with more than one product, each additional product can be added from the Case Form.Įnter the most suspect product here. This field is reflected in the General tab of the Case Form and is also available for duplicate searching for cases.Ĭlick the green dot to view and select justifications from the Argus Justification dialog box. The values of this field are configurable through the standard Argus Justifications dialog box.
#ARGUS DEVELOPER CERTIFICATION TRIAL#
(applicable to clinical trial cases only)Ĭlick Select to choose the Center ID from the Clinical Trial Selection dialog box. Study ID(applicable to clinical trial cases only)Ĭlick Select to choose the study ID from the Clinical Trial Selection dialog box. The Administrator can adjust the information in this list. For example, selecting Sponsored Trial makes the Study ID and Protocol ID fields available. The report type also impacts duplicate search. This determines the fields that are made available for entering case information. Select the item that best describes the type of report. This may or may not be the reporter's or the patient's country of residence. Select the country where the adverse event occurred. The Receipt Date cannot be entered as a partial date.Įnter the date on which this information was received by Central Safety. You can open the case and enter data at any time.Įnter the complete date on which your company became aware of the case. If you click No, the case is saved and closed. Note: If you click Yes, the Case Form page appears. When the case creation message appears, click Yes. If the case number is not automatically generated, enter it according to your company guidelines. If Argus has been configured to generate a case number automatically, it is generated now. The button is enabled only if the Save operation fails or when the case is booked-in successfully. Once clicked, this button is hidden from the screen. You can search for a document from the database by specifying a search criterion in this dialog box. The Document Lookup dialog box is displayed. Select URL Reference from the drop-down list.Ģ. Click B.Ĭontact your system administrator to configure this location.ġ. On the File Attachment -Webpage dialog box, double-click Browse and navigate to the relevant file. Select File Attachment from the drop-down list and click Add.ģ. Enter the Classification and Description, as applicable.
Click Add on the Attachments and References tab.Ģ. The causality relationship is the causal relationship between the clinically most important event and the suspect drug that is entered in the Initial Case Entry form.įor Seriousness Criteria, check the appropriate checkboxes to indicate the seriousness of the case, as appropriate.ġ. Under Reported Causality, select the reporter's assessment of causality. When the Bookin screen is opened, the search results from the last search are displayed again.Įnter relevant information in the following sections: When a duplicate search is performed, the system remembers the results until the user logs out of the system or performs a duplicate search again. If a duplicate case does not appear, click Continue in the Initial Case Entry form to display the BookIn and Attachments and References sections. If a duplicate case exists, open the case to enter further information related to the existing case. Review the search results for a duplicate case. On the Initial Case Entry page, enter the mandatory information (fields with a red flag) and click Continue.Ĭlick Search to confirm this is not a duplicate case.Ī list of cases that match the criteria you entered on the form is displayed. On the Home page, hover over the Case Actions menu and click New. From the Initial Case Entry form, you can decide to bookin a case before entering further case information in the Case Form.
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