Managing Study Responsibilities & Staff Delegations

Learn how to manage delegated responsibilities for study team members.


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

The information on this page is for managing delegated responsibilities for study team members at the level of the study. Before enabling the Digital Delegation feature for a study, it’s important to first curate the list of Responsibility records for your research organization or site and assign responsibilities to SiteVault users. When you enable the feature, the curated lists of responsibilities and assignments are copied to the study and become the default lists for your study and study team members. See the Managing Research Organization and Site Responsibilities and Managing Person Responsibilities pages for more information.

See the Digital Delegation page to watch short how-to videos on using the Digital Delegation feature.

Enabling Digital Delegation

Complete the following steps to enable the Digital Delegation feature for a study:

  1. Navigate to the Studies tab and open the study, then expand the Settings section.
  2. Select Edit Settings, select the On option, then select Save Settings.
  3. Refresh the page (for the changes to be displayed).

A new Study Responsibilities section is displayed that contains the list of standard and any custom responsibilities that have been added for your research organization or site. In addition, for any study staff assigned to the study, a new Study Staff Delegations section is displayed on their Study Assignment page.

Managing Study Responsibility Records

When you enable the Digital Delegation feature for a study, the Study Responsibilities section is pre-populated with the default list of responsibilities defined for your research organization and site.

Once the initial list of Study Responsibilities has been created, you can adjust them as needed for the study. For example, you can delete or deactivate a responsibility if it’s not relevant to the study, or you can create new responsibilities for the study. Any adjustments you make to the study responsibilities do not impact other studies.

Note If you update the list of research organization- or site-level responsibilities after enabling Digital Delegation for study, the study responsibilities aren’t updated automatically. You can complete the steps in the section below to add the responsibility to the study.

Creating Study Responsibility Records

Complete the following steps if you want to create a new Study Responsibility record:

  1. Navigate to and open the study, expand the Study Responsibilities section, then select Create.
  2. Complete one of the following steps depending on whether you want to add an existing Responsibility record or create a new one:
    • If you want to add an existing research organization- or site-level responsibility to the study, search for and select the record in the Responsibility field. Tip: Select More Search Options (the binoculars button) in the field to open a dialog that enables you to search and filter the available records.
    • If you want to create a new responsibility, select into the Responsibility field and select Create Responsibility. The Create Responsibility option is at the bottom of the list of responsibilities.

Editing, Deactivating, or Deleting Study Responsibility Records

Complete the following steps to manage Study Responsibility records:

  1. Open the study responsibility that you want to manage. The record can be accessed from the Study Responsibilities section of the study.
  2. If you want to edit the responsibility, select Edit. Note that you can only edit the Notes field of the record.
  3. If you want to delete the record, select Delete. This deletes the responsibility from the study but not the research organization- or site-level responsibility it’s based on.
  4. If you want to deactivate the record, select Change State to Inactive.

Adding Site Staff to a Study

See the Managing Study Assignments, Products, and Organizations section of the Managing Studies page for more information on adding site staff to a study as study team members.

Managing Study Staff Delegations

When you add a site staff member to a study with the Digital Delegation feature enabled, the person’s default list of responsibilities are copied as delegations to their study team assignment. You can view the list of delegations in the Study Staff Delegations section of the user’s Study Assignment page.

Once you’ve added the staff member to the study, you can update their study delegations as needed. For example, you can delete a delegation if it’s not relevant to the study, or you can create new delegations for the user.

The following considerations also apply to a study team member’s study delegations:

  • If you update the user’s default list of responsibilities after adding them to the study, their study delegations aren’t updated automatically. You can complete the steps in the section below to add a proposed study delegation for the user.
  • If study team assignments already exist for a study before you enable the Digital Delegation feature, the user’s default list of responsibilities may or may not be copied to the study when you enable the feature depending on the state of the user’s Study Assignment record. If the Study Assignment is in the Proposed state, the person’s list of default responsibilities are copied as Proposed study staff delegations. If the Study Assignment record is in the Active state, the default responsibilities aren’t copied, but you can add them using the steps below.
  • If you make a change to a study team member’s delegations after the PI has already approved, the status of the user’s Study Assignment record is updated to Proposed Changes - Acceptance Needed. Ensure that you resend the proposed study delegations for acceptance and PI approval when you’re finished.

Creating Study Staff Delegation Records

Complete the following steps if you want to create a new study delegation for a user:

  1. Navigate to and open the Study Assignment page for the user, expand the Study Staff Delegations section, then select Create.
  2. Search for and select the record in the Study Responsibility field. Tip: Select More Search Options (the binoculars button) in the field to open a dialog that enables you to search and filter the available records.
  3. Optionally, enter a start date for the proposed delegation.
  4. Select Save.

Editing, Deactivating, or Deleting Study Staff Delegations

Complete the following steps to manage Study Staff Delegation records:

  1. Open the record for the record that you want to manage. The record can be accessed from the user’s Study Assignment page on the study.
  2. If you want to edit the delegation, select Edit. Note that you cannot edit records that are active (have been approved by the PI).
  3. If you want to delete the record, select Delete.
  4. If you want to deactivate the record, select Change State to Inactive.

Viewing the Delegation of Authority Log

When the PI approves, SiteVault generates a new or updated version of the Delegation of Authority (DoA) document and files it to the PI Oversight section of the study eBinder. You can view the DoA in your eBinder or by searching in your Library.

Appendix - Additional Scenarios

Site Staff Member No Longer Assigned to a Study

Complete the following steps if you need to update your DoA document to remove a study team member and their delegations from a study:

  1. Navigate to the study and open the Study Assignment page for the study team member in the Study Team Assignment section.
  2. Select Change State to Make Inactive from the Workflow and State Change menu, and start the action. The status of the study team member’s record is updated to Make Inactive.
  3. Complete the steps in the Sending Accepted Study Delegations for PI Approval section on the Sending Delegations for Acceptance and Approval page.

After the PI approves, the DoA is updated to indicate that the staff member along with their delegated responsibilities have been made inactive on the study. The staff member’s Study Assignment record is also updated to Inactive.

Site Staff Member Name Change

Complete the following steps if you need to update the name of a site staff member in your DoA document:

  1. From the Profiles > Users tab, open the User record for the site staff member and edit the name as needed.
  2. Navigate to the study and open the Study Assignment page for the site staff member.
  3. Select Name Change Annotation from the Workflow and State Change menu, enter a note, then start the action.
  4. Complete the steps in the Sending Accepted Study Delegations for PI Approval section on the Sending Delegations for Acceptance and Approval page.

After the PI approves, the DoA is updated with the note about the name change.

Updating the PI on the Study

Note When you update the PI on the study, the status of any existing study delegations are updated to Accepted - PI Approval Needed. The delegations will become active again when the new PI approves.

Complete the following steps if you need to update the PI in your DoA document:

  1. Navigate to the Study Assignment record on the study for the current PI, and update the status of the record to Inactive.
  2. Create a new Study Assignment record for the new PI, and update the status of the record to Active.
  3. Complete the steps in the Sending Accepted Study Delegations for PI Approval section on the Sending Delegations for Acceptance and Approval page.

Managing Person Responsibilities
Sending Delegations for Acceptance & Approval
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