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.
|
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:
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 checkbox 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 checkbox 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 checkbox 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. |
Parent topic: Configuring Clinical Studies