Manage Studies

The “Manage Studies” view within the Enterprise Manager gives you the capability to manage studies, participant lists, and study templates.

1.Manage Studies Overview

The Manage Studies View lists all of the Studies within the selected Project.

NOTE: Studies are only listed if DatStat Discovery has been licensed and activated.

Studies Tab

ManageStudies.gif

EditStudyicon.gif Displays the Edit Study screen to configure the general properties of the study

DeleteIcon.gif Delete Study

EditparticipantList.gif Displays the Edit Participant List Screen to allow modification of the List Name, Project, and Inherited Columns

ExportStudy_Icon.gif Export Study – Allows an entire study to be exported as an xml file

SaveStudyAsTemplateIcon.gif Save Study as Template

 

Study Templates Tab

Lists all of the Study Templates available within that Project

 

ManageStudyTemplates.gif

Templates cannot be edited. They can be deleted.

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2.Creating a New Study

Add Study

To create a new Study without an existing file or template, follow the steps below:

NOTE: The Derived Participant List intended for use with the Study must be created first.

  1. Must be logged in as a User with the Administrator and/or Study Administrator Role for the Study/Project or System
  2. Click on the Enterprise Manager Link in the upper right corner of the DatStat Gateway interface if not taken directly there at login
  3. Expand the Project where the study will be located
  4. Click on the Studies icon
  5. Click on Take Action in the upper left
  6. Select Add Study
  7. Enter the Study Name and Study Description – Optional
  8. Change the Project if desired
  9. Select the Participant List that will be used for this study
  10. If Case Owners will be used in this Study Check the “Enable Case Owner” checkbox. This will Enable that definition in the Participant List

NOTE: Only Derived Lists may be used for a Study

  1. Edit the Alternate Study Terms if desired
  2. If a System Extension is going to be added, click on the System Extension Tab and enter the SDK Username and Password
  3. Click Save and OK

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3.Add Study from File

A Study may be imported from a file that was exported from another Study or System. Because Studies now are required to be associated with a Derived Participant List, Users must specify a Derived Participant List name.

 

NOTE: Users can only import a study to a system with the same product version number from which it was exported. For example, a Study exported from a Discovery 2.x system cannot be imported into a Discovery 3.x system.

 

ImportStudy.gif

Create New Master Participant List

  1. Must be logged in as a User with the Administrator and/or Study Administrator Role for the Study/Project or System
  2. Click on the Enterprise Manager Link in the upper right corner of the browser if you haven’t been taken directly there at login
  3. Expand the Project where the study will be located
  4. Click on the Studies icon
  5. Click on Take Action in the upper left
  6. Select Add Study from File
  7. Select Create New Master Participant List or Merge with Existing Master participant List
  8. Provide a name for the new Master Participant List
  9. Provide a name for the new Derived Participant List

NOTE: Names must be unique for each Participant List and Study

  1. Enter the name of the new study
  2. Select the Project for the Study
  3. Browse to find the XML file to import for the study
  4. Add a Description if desired
  5. Click Next
  6. A window will come up with warnings about any caveats to the import
  7. Click Next
  8. Import will begin. On complete, a link will be available to begin configuring the study or click OK to finish

 

Considerations:

  • If an Event Handler specifies a specific User the User will be removed from the Event (e.g. IF DATSTAT CASEOWNER = ‘Joe Smith’ THEN <<DO ACTION>> will be removed from the workflow because Joe Smith does not necessarily exist in the system and if he does, it may be a different Joe Smith)
  • Surveys will be imported unless a survey with the same name already exist
  • Unique Surveys will be Imported but not automatically Published
  • Sites and Site Groups will be imported if the User is a System Administrator and they do not already exist in the system
  • If Relations are used they will be added to the Master Participant List and automatically inherited by the Derived List that was created

Merge with Existing Master Participant List

  1. Must be logged in as a User with the Administrator and/or Study Administrator Role for the Study/Project or System
  2. Click on the Enterprise Manager Link in the upper right corner of the browser if you haven’t been taken directly there at login
  3. Expand the Project where the study will be located
  4. Click on the Studies icon
  5. Click on Take Action in the upper left
  6. Select Add Study from File
  7. Select Merge with Existing Master Participant List
  8. Select the new Master Participant List from the drop-down
  9. Provide a name for the new Derived Participant List

NOTE: Names must be unique for each Participant List and Study

  1. Enter the name of the new study
  2. Select the Project for the Study
  3. Browse to find the XML file to import for the study
  4. Add a Description if desired
  5. Click Next
  6. A window will come up with warnings about any caveats to the import
  7. Click Next
  8. Import will begin. On complete, a link will be available to begin configuring the study or click OK to finish

 

Considerations:

  • If an Event specifies a specific User the User will be removed from the Event (e.g. IF DATSTAT CASEOWNER = ‘Joe Smith’ THEN <<DO ACTION>> will be removed from the workflow because Joe Smith does not necessarily exist in the system and if he does, it may be a different Joe Smith)
  • • Surveys will be imported unless a survey with the same name already exist
  • Unique Surveys will be Imported but not Published
  • Sites and Site Groups will be imported if the User is a System Administrator and they do not already exist in the system
  • If Relations are used they will be added to the Master Participant List and automatically inherited by the derived list that was created
  • Relations from the XML file will be added to any already existing Relations in the Master file
  • Master Custom Participant Definitions specified in the export file will be automatically added to the newly created Derived Participant List rather than being associated to the Master Participant List

Import as a Template

  1. Must be logged in as a User with the Administrator and/or Study Administrator Role for the Study/Project or System
  2. Click on the Enterprise Manager Link in the upper right corner of the browser if you haven’t been taken directly there at login
  3. Expand the Project where the study will be located
  4. Click on the Studies icon
  5. Click on Take Action in the upper left
  6. Select Add Study from File
  7. Select Import as a Template
  8. Enter the name of the new Study Template
  9. Select the Project for the Study Template
  10. Browse to find the XML file to import for the study template
  11. Add a Description if desired
  12. Click Next
  13. The Template will now be in the Data Grid in the Study Templates tab

 

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4.Add Study from Template

  1. Must be logged in as a User with the Administrator and/or Study Administrator Role for the Study/Project or System
  2. Click on the Enterprise Manager Link in the upper right corner of the DatStat Gateway interface if not taken directly there at login
  3. Expand the Project where the study will be located
  4. Click on the Studies icon
  5. Click on Take Action in the upper left
  6. The Import Study Screen opens
  7. Select Add Study from Template
  8. The Add Study from Template Screen opens
  9. Select Create New Master Participant List, Merge with Existing Master participant List or Import as a Template
  10. Provide a name for the new Master Participant List
  11. Provide a name for the new Derived Participant List

NOTE: Names must be unique for each Participant List and Study across the DatStat Instance.

 

  1. Enter the name of the new Study or Study Template
  2. Select the Project for the Study or Study Template
  3. Browse to find the XML file to import for the study
  4. Add a Description if desired
  5. Click Next
  6. A window will come up with warnings about any caveats to the import
  7. Click Next
  8. Import will begin, on complete a link will be available to begin configuring the study or click OK to finish

 

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5.Deleting a Study

  1. Must be logged in as a User with the Administrator and or Study Administrator Role for the Study/Project or System
  2. Click on the Enterprise Manager Link in the upper right corner of the DatStat Gateway interface if not taken directly there at login
  3. Expand the Project where the study is located
  4. Click on the Studies link
  5. Click on the Delete Study icon DeleteIcon.gif  in the row of the study to delete
  6. User will be prompted to type “DELETE” to confirm this action
  7. If sure, Click OK

 

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6.Export Study

Clicking the Export Study icon will generate an XML file that contains all components of the study. The file can be transmitted over e-mail in the same way that survey files can be transported.

NOTE: User-Specific and Participant-Specific Actions and Workflow will not be included in an Export.

 

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7.Save Study as Template

Saving a Study as a Template speeds up Study creation and maintains consistency of Study Workflow. Study Templates are saved within the same database, so they can be used in turn to create new Studies. To use Study Templates in a different instance of DatStat Discovery (meaning a different database and installation), the Study would have to be Exported.

 

To Save a Study as a Template:

  1. Log in to Enterprise Manager as either the System Administrator or a User with sufficient permissions to work with in the project the study is in.
  2. Expand the appropriate Project
  3. Select the Studies icon
  4. Select the Save as Template Icon SaveStudyAsTemplateIcon.gif in the row of the study to use
  5. Enter the Template Name and Description
  6. Select the Project where this Template will reside – Make sure it is in a project that the appropriate people can access

EM_SaveStudyTemplate.gif

  1. Click Save and OK

 

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