Adding Clinical Study Configurations

This screen helps capture study information (study specifics, products involved in the study licensed countries associated with the study and the clinical references used in the expedited reports). Study Information is required if a case has been reported while conducting a study and the participating product(s) belong to the company. This data is reflected in multiple expedited and periodic reports and case form-general information section.

Be aware of the following:

• The IND Reference Number drop down displays only those reference numbers (license numbers) associated with a product with a License Type of Investigational.
  • Console > Business Configuration > Studies > Clinical Reference section (in middle of screen).

  • The Reference Number drop down field should be limited to IND (Investigational) US Licenses Number only.

• The Study Name on the Study Configuration can be a maximum 70 Characters (same as the Product name).

Use the following procedure to add a study:

1. In the Business Configuration section, select Studies.
2. In the left panel, select a filtering criterion.
3. Select a Study and click to view the study details in the right panel.

   Note:

   Ensure that you select the study-level folder to view the details of the study.
4. The details of the study appear in the right panel.
   

   Tip:

   • You can alternatively click Add Study to create a new study.
   • Click Copy to copy of the Study Name and the Study Type data to the new Study.
   • Click Copy with Products to copy the Study Name and the Study Type data, as well as to copy the blinded and open products.
5. Enter the Study ID and Study Name associated with the Study.
6. Select the Project ID for the Study, from the drop-down list.
7. Select the Study Type associated with the Study, from the drop-down list.
8. Enter the Other ID. This will be an alternative id for the Study.
9. Select Template to associate a template with the Study.
10. Select the Observer Study Type(E2B) from the drop-down list.

About Filtering Criterion

The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Business Configuration section.

Using Organized by

The filtering browser displays in the top-left corner of the left panel. The studies section can be filtered based on of any of the three combinations shown in the following illustration. The generated output is visible in a tree-format, in the left panel, based on the entire categorization of Projects, Studies, Products.

If you enable the Organized by Study/Products, only the Study and Product views will be available in the tree view in the left panel.

The Argus Console helps you to filter information further for the Business Configuration section. Once you have selected the Organized by, you can specify whether your search should contain or start with specific alphabets.

The filtering criterion shown in the following illustration, enables the system to search for all Projects/Studies/Products data that contain the term Cure.

The left panel displays the tree view of the Projects/Studies/Products based on the filtering criterion.

Tip:

The number displayed next to the folder signifies the number of studies/products within that project/studies family.