Project Wizard

Introduction 

Below are explained the project wizard steps for creating a new project. 

Wizard Step 1:  Files

Use the Files page to upload source files and any supplementary documents, such as LoT and mock shell files. Select the button “+ Add files” or the “Drag & drop” option to add the files needed for the project. Verify arranges each file in the correct file category.

If a source file exceeds the size limit or encounters other file-related issues, an alert will appear prompting you to take action, please note that if uploaded files exceed the project limit, an alert will notify you to remove files. For more details, please (see Project Upload Constraints).

Note: You can now create a project by uploading only Mock Shells (or Mock Shells and LoT files) without TLFs to set up the project foundation early.

Wizard Step 2: Info

This page contains general information about the project. The information you provide affects which checks are offered by the wizard during the analysis step.**

Enter the following information on this page:

• Protocol number – The protocol number of the study. The protocol number is automatically extracted from the files, but you should review it.  
• Project name – The name you select should be identifiable and must be unique to the study. A best practice is to include the protocol number in the project name. 
• Delivery date – Select the desired delivery date.
• Delivery type - Defines the core review flow indicator for the project. Project analyses, tasks, and reporting are logically grouped and tracked around this specific delivery scope.

• Project stage – Select the current phase of the review and validation workflow from the dropdown menu.  Managers can map required project stages in conjunction with the Beaconcure Customer Success Team.

• Project type – Select Vaccine or Drug as the study type.
• Therapeutic area** – Select a therapeutic area (TA) from the dropdown menu.  If none of the options fit your study, you can choose the “Other” option. 
• Data Blinding: Select whether the study is Blinded or Unblinded. This selection is mandatory during project creation and becomes permanently locked and non-editable once the project is created. 
• Study Design: Select the study design, either Parallel Study (default) or Cross-Over Study. This selection remains editable and impacts specific system validations, such as disabling the Hsum check for cross-over studies.

Wizard Step 3: Share 

Use the Share page to share the project with other users, by entering their user names in the dialog box and selecting it from the dropdown. The users you share your project with will gain editing permissions and receive notifications regarding changes in the project. (See Share a Project for details) 

Wizard Step 3: Analysis** 

Use the Analysis page to define the analysis type and checks that Verify performs on your source files. 

There are two options for analysis: Fast Track and Deep Analysis. For more information refer to the section Fast Track vs Deep Analysis Track. You can also use the search option for selection of specific checks to run.

Please note that there are two checks that require you to provide additional input on this page**:

• N Consistency – Select the file name of the reference table that will be used for comparison.
• Date Comparison – Indicate the Snapshot Date of the study.

Save and Close: Complete the Project Creation

Select SAVE & CLOSE to complete project creation. The following screen appears. Do not close this screen until you receive the message that the project has been created; you will also receive an email about the creation of the project. You and all users shared to the project will receive an email notification from Verify when your project analysis is complete.