Studies

Learn how to create and manage studies.


On This Page


Viewing Studies

The Studies tab holds all the information related to the studies that you’ve been assigned. To view a study, navigate to the Studies tab and select the study from the list. You can use the filters to narrow the list to quickly find the study that you need to view.

Creating Studies

Study records capture critical information such as the Principal Investigator, Site, and Sponsor. You’ll add studies to documents so that you can easily find the documents later in the eBinder, Library, or by searching.

Complete the following steps to create a study:

  1. In the Studies tab, select Create.
  2. Enter required and any additional information as needed, then select Save. The study record details page is displayed.

Once the study has been created, you can add products, study team members, partners, and external users by expanding the appropriate section and selecting the Create button.

Managing Study Lifecycles

A study lifecycle is a sequence of states (such as Initiating, Active, and so on) that a study can go through during its life. The following figure defines and illustrates the sequence of states that are available for studies in SiteVault:

Study Stages

Complete one of the following steps to change a study’s lifecycle state:

  1. From the list view of studies in the Studies tab, select the appropriate lifecycle state (such as Change State to Initiating) from the study’s Actions menu in the Study Identifier column.
  2. From the study detail page, select the appropriate lifecycle state (such as Change State to Active) from the Actions menu in the upper-right corner.

Study Product, Study Team, and Study Organization Lifecycle

The following figure illustrates the sequence of stages that Study Product, Study Team, and Study Organization records can go through during their life:

Study related objects lifecycles

Make sure to change the state of the added study team members to Active by selecting the Actions menu to associate the team members profile documents with the study.

The actions menu is displayed when you position your pointer over the team member on the table or by selecting the team member name.

Assigning Study Teams, Partners, and Products to Studies

Assigning users to the study team grants study team users access to the study and its documents. Assigning users to the study team and making their assignment Active also files their current profile documents under the study automatically. Assigning organizations to the Partner Organizations section and making their assignment Active files the organization’s current profile documents under the study automatically. Assigning investigational products under the Products section allows for the upload of product-specific documents.

Deleting Studies

Deleting Studies & Profiles

Note You can only delete studies that are in the Pre-award or Cancelled state.

To delete a study, select Delete from the study’s Actions menu in the list view of studies or on the study record detail page.


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