Learn how to create and manage studies.
Study Overview
Studies capture critical information about your site’s studies such as study team assignments, partner organizations, and investigational products. Studies are also associated with documents so that you can easily find study-related documents in the eBinder or by searching in the Library.
Study Lifecycle
The study lifecycle is a sequence of states (such as Initiating, Active, and so on) that a study can go through during its life. When you create a study, SiteVault automatically sets the status of the study to Pre-award. You can progress the study state to match your study activities.
The following figure defines and illustrates the sequence of states that are available for studies in SiteVault:
Study Tasks
View a Study
You can view the studies to which you have access in the Studies tab.
- Site Staff users without an add-on permission can only view the studies to which they are assigned as study team members.
- Site Administrators can view and manage studies across the site that’s currently selected in the vault selector.
- Research Organization Administrators can view and manage studies across their research organization by selecting your research organization in the vault selector.
Complete the following steps to view a study:
- Navigate to the Studies tab.
- Locate and select the study from the Study Identifier column.
Create a Study
Complete the following steps to create a study:
- Navigate to the Studies tab.
- Select Create.
- Enter required and any additional information as needed.
- Select Save to complete the process.
Once a study is created, you can add products, study team members, partner organizations, and monitor or auditor assignments.
For more information, see the Creating a Study training video.
Edit a Study
Complete the following steps to edit a study:
- Navigate to the Studies tab
- Locate and select the study from the Study Identifier column.
- Select* Edit from the All Actions menu.
- Complete the updates.
- Select Save to complete the process.
Change the Study Lifecycle State
Complete the following steps to change the study state:
- Navigate to the Studies tab
- Locate and select the study from the Study Identifier column.
- From the Workflow Actions menu, select the appropriate lifecycle state.
Delete a Study
Note: You can only delete studies that are in the Pre-award or Cancelled states. Moreover, the study cannot have any documents or associated records such as Study Assignments or Study Products.
Complete the following steps to delete a study:
- Navigate to the Studies tab
- Locate and select the study from the Study Identifier column.
- Select Delete from the All Actions menu.
- Complete the updates.
- Select Save to complete the process.
Export Study Documents
See the Exporting Study Documents page to learn how to export all major versions of documents for a study.