Managing Studies

Learn how to create and manage studies.


Note Only SiteVault users with the Site Administrator system role can complete the tasks on this page.

Viewing Studies

You can view the studies to which you have access in the Studies tab. To view the full record of an individual study, select the record from the list in the Study Identifier column.

Site Staff users without an add-on permission can only view the studies to which they are assigned as study team members. Site Administrator users can view and manage studies across the site that’s currently selected in the vault selector. Research Organization Administrator users can view and manage studies across their research organization by selecting your research organization in the vault selector.

Creating and Editing Studies

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.

To edit a study (for example, to add a Sponsor), select Edit from the All Actions menu.

Once the study is created, you can add products, study team members, partner organizations, and monitor or auditor assignments. See the Managing Study Assignments, Products, and Organizations section below for more information.

Managing the Study Lifecycle

A 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. The following figure defines and illustrates the sequence of states that are available for studies in SiteVault:

Study Stages

To change the state of a study, navigate to and open the record for the study, then select the appropriate lifecycle state (such as Change State to Active) from the Workflow Actions menu.

Managing Study Assignments, Products, and Organizations

Assigning site staff and monitors or auditors to studies grants them access to view study-related documents and, for Site Staff users, the ability to view the study. Adding investigational products and partner organizations to the study enables you to associate Organization or Product Profile documents with a study.

To create a study assignment, product, or organization, expand the applicable section and select Create. Refer to the information in the subsections below for additional considerations when creating study-specific data.

To edit a study assignment, product, or organization, open the record (by selecting it) and select Edit from the All Actions menu.

To delete a record, open the record and select Delete from the All Actions menu. Note that study team assignments and monitor or auditor assignments can only be deleted in the Proposed state.

Study Team Assignments

For study team assignments, select a study role and user from the lists. Note that the user must already exist for your site. See the Managing Users page for more information on creating users.

SiteVault creates the study team assignment in a Proposed state. To automatically file all of the user’s Profile documents to the study, update the status of the user’s Study Assignment record to Active.

When you add a study team member with the role of Principal Investigator and change the state to Active, the Principal Investigator field on the study is automatically updated to that PI. If you need to update the PI on the study, change the state of the study assignment for the current PI to Inactive, then add and activate the new PI.

Monitor & Auditor Assignments

For monitor or auditor study assignments, select a study role and user from the lists. Note that the user must already exist for your site. See the Managing Users page for more information on creating users.

If you want to schedule a specific period of time in which the external user has access to the study, select a start and end date in the Access Start Date and Access End Date fields, respectively. Note that this restricts the user’s access to this study only and not to any other studies to which the user might be assigned.

If you enter start and end dates, the user’s study assignment will be Active during the scheduled time and Inactive outside of the scheduled time. Otherwise, SiteVault creates the study assignment in a Proposed state. If you want to restrict the user’s access to the study, you can change the state of the record to Active then to Inactive.

Products

For a study product, select a product role and the product from the lists. If the product doesn’t already exist, select Create Product from the Product list. See the Managing Products page for more information on managing products for your research organization or site.

Partner Organizations

For a study organization, select a role and organization from the lists. If the organization doesn’t already exist, select Create Organization from the Organization list. See the Managing Organizations page for more information on managing products for your research organization or site.

SiteVault creates the study organization in a Proposed state. To automatically file all of the organization’s Profile documents to the study, update the status of the Study Organization record to Active.

Study Assignments, Study Product, and Study Organization Lifecycles

The following figure illustrates the sequence of stages that Study Assignment, Study Product, and Study Organization records can go through:

Study related objects lifecycles

To change the state of one of these records, open the record (by selecting it) and select the appropriate action from the Workflow Actions menu (such as Change State to Active).

Managing Study Participants

See the Managing Study Participants page to learn more about how to create and manage Participant records for your study.

Exporting Study Documents

See the Exporting Study Documents page to learn how to export all major versions of all documents for a study.

Deleting Studies

Note You can only delete studies that are in the Pre-award or Cancelled state. Moreover, the study cannot have any documents or child records such as Study Assignments or Study Products.

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


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