Field Descriptions

The following table lists and describes the fields in this section.

Field or Control Name	Description
Study ID	This is the Study ID.
Project ID	This is the project ID for the study.
Other ID	Enter any other ID associated with this study.
Observe Study Type (E2B)	This enables you to select the study type from a drop-down list. This element is populate from the Case From Clinical Study section of the application. The value selected in Study Configuration, Observe Study Type (E2B) is populated in the Case Form Study section when you selects the Clinical Study. The system updates the standard E2B profiles (EMA, FDA, and ICH) to populate the tag.
Template Only	Select this checkbox to select only a template for the study.
Study Development Phase	Enables you to choose the study phase.
* Non-Interventional Study	Enables you to identify a study as a non-interventional study. The available options are Yes and No. The default value is set to No. This field is not used in the application (Case Form, Reports) for this release.

The following table lists and describes the arms available in this section.

Arms Field or Control Name	Description
Study Name	Enter the name of the study. This is a mandatory field. You can add upto 99 Arms to a study.
Study Type	Enter the type of study. Note: The Study Name and the Study Type fields must be unique for a study.
Primary License	Select the applicable primary license from the list of licenses available in this drop-down list. These licenses are displayed as per the products that have been selected for the Arm. This drop-down list is displayed as blank for a new Arm.
Copy	Click this button to copy a selected Arm.
Delete	Click this button to delete a selected Arm.

The following table lists and describes the product fields available in this section.

Products Field or Control Name	Description
Product Name (Dosage Form /Strength/Units)	Provides information about the Product Name along with the (Product formulation/Product Concentration/Product Units).
Blinded	Check this checkbox to configure a blinded study. You cannot check this checkbox if the Study Type for that Arm is not blinded. Note: A Study is eligible for Unblinding checkbox is enabled when a study has at least one Arm with Study type as Blinded (Single/Double). The Study is eligible for Unblinding checkbox should be unchecked in study configuration. If this checkbox is checked, you will be able to see the complete case data even if he has protection enabled.
Product Type	Allows you to select a Product Type from the drop-down list. The possible values are: Investigational Product - This value indicates that the study product is an experimental drug being studied in the clinical trial. Comparator - This value indicates that the study product is an approved drug, and it is used in the clinical trials for comparing results with the investigational product. Placebo - This value indicates that the study product is a dummy drug. This drug is used in the studies to eliminate bias that might occur due to knowledge of who receives which treatment. No Study Drug Given - This value lets you classify an event into the No Study Drug Given category if a serious adverse event occurs even before a patient has started taking any study drug. Additional Study Drug - These are additional or background drugs that are given as part of a combinational therapy. These drugs are generally given with both investigational products, and comparators. The additional study drug does not impact the case categorization, but it is an attribute for this configuration in the product temp table. In PBRER and DSUR reports, count of events are stratified against the product type values: Investigational Product, Comparator, and Placebo.
Products -Add WHO Drug	Opens Search Screen for selecting a non-company product.
Products -Add Product	Opens Search Screen for selecting a company product.
Products -Delete	Deletes the selected product row.

The following table lists and describes the clinical reference fields available in this section.

Clinical References Field or Control Name	Description
Reference Type	Shows the various reference types that can be setup for this study.
Country	Enables you to select a country for the clinical reference type.
Reference Number	Captures the reference number that will be reflected on the regulatory reports.
Add	Enables you to add another clinical reference.
Delete	Enables you to delete the selected clinical reference.
Countries	Enables you to select a country for the clinical reference type.
License	This is the license of the primary (company) product participating in the study.
Product Abbreviation	This enables you to enter an up to 5 character abbreviation of the study name which would be used in Case numbering when Product' is selected in the system numbering configuration in case of study cases.
Centers	The system displays the selected study centers for the study.
Study Description	Enables you to enter a brief description of the study. Opens the study description in zoom mode and provides a spell check dialog. Opens the multi lingual dialog allowing you to choose the language from the list. The global language icon is displayed if the study description data is entered in a language different than English or Japanese.
Investigator Alert	Enables you to select an existing Advanced Condition. Under Investigator alert, an advanced condition can be created / selected. When this condition is satisfied, the system automatically sends an e-mail to the investigator group associated with this study.
Investigator Alert - select	Opens up the Advance Condition browser.
Study is eligible for Unblinding	Check this box if the study can be unblinded. If the Study Type selected is Not Blinded", this field is disabled. This check box is enabled when a study has at least one Arm with Study type as Blinded (Single/Double).
Enable Study Specific Encoding	User checks this box if Study specific Auto encoding has to be enabled.
Autoencoding: Drugs(dict)	If unchecked (default state) the study will use the dictionaries configured using the Case form Configuration options. If checked, the Auto encoding button is activated.
Autoencoding: Events & Indications	Select this field to enable the system to encode Events & Indications using the dictionary you selects from the list.

The following table lists and describes the study reporting fields available in this section.

Study Reporting Field or Control Name	Description
Products -Add Product	Opens the Search screen for selecting a company product.
Products -Delete	Deletes the selected product row.
Inherent Reporting Rules Form	This drop-down list is populated from all the Study templates which are configured for SUSAR Reports. Users can use the pre-defined SUSAR reports by selecting the applicable template from the drop-down list.
Always report	Usually the study-specific reporting is configured to handle reporting requirements for non-company products, e.g. Placebo or a comparator, as the company-based reporting is taken care by the license based reporting logic utilized in Argus. However, checking this check box will force Argus to check for qualifying expedited reporting rules based on the country, license type and reporting destination specified even if no non-company products are identified as study drugs. If the check box is unchecked then expedited reports based on the study-specific reporting rule will only be scheduled if there is a non-company product identified as a study drug.
Country	Specifies what country's reporting rules the console should consider. The list includes countries for which the expedited reporting rules exist.
License Type	Specifies what license type to consider for the specified country. Only applicable license types, i.e. Marketed Drug, Device, Vaccine or Investigational Drug, Device, Vaccine are displayed in this drop down list. For example if a country Germany" only has reporting rules for investigation drugs, then Investigational Drug" is the valid drop-down element.
Reporting Destination	This field is optional and by default will have the value All. Specifying any value in this list limits the reporting rules to be evaluated to the selected country, license type and reporting destination. The drop-down list is filled with valid destinations (regulatory authorities) for the country and license type selected based on the expedited reporting rules. For example, if you has selected Germany, Investigation Drug and there are reporting rules for Germany with destinations of BfArM" and Drugs R us" then only these two destinations (LM: regulatory authorities) are displayed.
Time Frame	This field cannot be searched or altered, but is included for informational purposes. Based on the country, license type and reporting destination selected, the system determines and displays all possible time frames in ascending order separated by a comma.
Possible Report Forms	This field cannot be searched or altered, but is included for informational purposes. Based on the country, license type and reporting destination selected, the system should determine and display all possible report forms in alphabetical order separated by a comma.

Oracle Argus Safety Japan specific fields

Field or Control Name	Description
Clinical Compound Number	Enables you to enter clinical compound information.
Target Disease Indication	Enables you to enter disease information.
Study Development Phase	Displays a list of all valid study development phases configured in the study development code lists.
Are any subjects given this investigational drug?	Select from the available options, or enter as desired.
Comments	Enables you to enter relevant comments regarding the study.
J Data Entry	This button appears only to Argus J users. When you click J Data Entry the application opens the Study Configuration dialog box with Japanese localization.
Test Drug Type	This drop-down list appears only to Argus J users and it is not used in the out-of-the-box Argus functionality. It is available for usage in advanced conditions. This drop-down list displays the types of test drugs. The supported values are Blank, Main Test Drug, Test Drug and Other than Test Drug. The default value is Blank.