Setting Up Study Training

The Study Training application allows Study Managers, or authorized users, to refine training plans and assignments based on a Learner’s association with a Study, and can further refine the training set by Study Country and Study Site. In addition to standard Training training matrix setup, Study Managers will want to set up a few components specific to Study Training.

For example, if the Study Manager wanted participants in a study at the “Dr. Vern & Associates” site to receive site-specific training, they could select the Dr. Vern & Associates Study Site record in the appropriate Curriculum. When Training automation creates Training Assignments, it will check that the Learner is associated with Dr. Vern & Associates before assigning that Curriculum’s set of training requirements.

About Study Training Matching Rules

When a Study Manager adds a Person to a Study, Vault creates a Study Learner Role -Person relationship record which includes a system-managed matching rule. Based on that matching rule, Study Training filters the Curricula associated with the Study Learner Role to only those Curricula appropriate for the Study, Study Country, or Study Site, and assigns them via Training automation.

Setup Overview

Study Managers should perform the following during Study Training matrix setup:

  1. Create Study, Study Country, and Study Site records to suit your needs.
  2. Create Study Learner Roles.
  3. Create Study Curricula and specify Study, Study Country, or Study Site.
  4. Create any necessary Crosslinks to training documents in other Vaults.
  5. Create Training Requirements and optionally specify Study metadata.
  6. Assign Persons to a Study.

If enabled, the Study Training Matrix Builder allows an authorized user to rapidly assemble the training needs for a given Study.

Study Training uses a combination of metadata in the form of Study, Study Site, and Study Country to match training to the correct Learners. To set up matching for a given study, Study Managers should first create a Study record:

  1. Navigate to Admin > Business Admin > Studies or to a custom Study object tab.
  2. Click Create.
  3. Fill in the required details, including a Study Number.
  4. Click Save.

Once the Study record is saved, the Study Manager should create any necessary Study Country values:

  1. On the Study record details page, navigate to the Study Countries section.
  2. Click Create.
  3. Select a Country record. If the intended value isn’t available, an Admin may need to add it to the Vault.
  4. Click Save.
  5. Repeat as necessary for all countries associated with the Study.

Once the Study Countries have been populated, the Study Manager should create any necessary Study Site values:

  1. On the Study record details page, navigate to the Study Sites section.
  2. Click Create.
  3. Enter a Study Site number.
  4. In the Study Country field, select one of the Study Countries created via the above steps.
  5. If the site is associated with an organization, select it in the Organization field.
  6. Click Save.
  7. Repeat as necessary for all sites associated with the Study.

Creating Study Learner Roles

Study Training uses the relationship between Study Learner Role and Person to match users with the appropriate training content. Once all Study-related records have been populated, the Study Manager should next ensure that all necessary Learner Roles of the Study Learner Role object type exist in the Vault. Optionally, for each Study Learner Role record, select the associated Study Team Role picklist value.

Creating Study Curricula

In order to work with Study Training matching rules, when Study Managers create Curricula, they must be of the Study Curriculum object type. Each Study Curriculum is associated with a Study, and a Study Manager may also associate it with a Study Country, Study Site, and, optionally, a Study Team Role. To create a Study Curriculum:

  1. Navigate to Admin > Business Admin > Curricula or to a custom Study Curriculum object tab.
  2. Click Create.
  3. Enter a Name.
  4. Select a Study. If this is the only study-related value you select in the curriculum, then Study Training will assign this curriculum to all Persons added to that Study.
  5. Optional: Select a Study Country. Selecting a country causes Study Training to exclude this curriculum for Persons with any other (or no) Study Country value selected when added to the Study.
  6. Optional: Select a Study Site. Selecting a site causes Study Training to exclude this curriculum for Persons with any other (or no) Study Site value selected when added to the Study.
  7. Click Save.
  8. Repeat as necessary to cover all necessary Study, Study Country, and Study Site scenarios.

Note: In Study Training, you cannot have both Study Curriculum and base Curriculum object records associated with the same Learner Role.

Creating Training Requirements for Study Training

Once a Study Manager has created their Study Curricula with appropriate matching data, they can create Training Requirements, populate them with Training Materials, including CrossLink documents. Then, either use them in the matrix builder or add them manually to the appropriate Study Curricula:

  1. On the Training Requirement object details page, navigate to the Curricula section.
  2. Click Add.
  3. Optional: As the number of Study Curricula in a Study Training Vault can be large, use the Filter section to narrow your selection to the Curricula for a particular Study,
  4. Select the Curricula to which you want to add the Training Requirement.
  5. Click OK.

Study Managers can optionally add Study, Study Country, and Study Site values to a Training Requirement. When Vault creates a Training Assignment from that Training Requirement, it also copies these values over to the Training Assignment. This can be useful for reporting data.

Study Training allows you to add CrossLink documents from other Vaults, such as an eTMF Vault, to Training Requirements as Training Materials. Ensure that the CrossLink is in a training-eligible lifecycle state, and that the source binding rule is set to Specific Document Version.

To update a CrossLink training document, follow these steps:

  1. In the Study Training Vault, perform the Create Draft action on the CrossLink document.
  2. In the source Vault, update the source document.
  3. In the Study Training Vault, move the CrossLink document to the Approved lifecycle state.

Updated CrossLink documents can trigger Training Requirement Impact Assessments just like documents that reside in the Study Training Vault.

Assigning Persons to a Study

As the final step of Study Training matrix setup, Study Managers should assign Persons to Studies, allowing automation to determine which Study Curricula to assign. To allow Study Managers or other authorized users to to assign Persons to a Study, a Vault Admin should add the LearnerRole-Person object to the Study object page layout.

To assign Persons to a Study:

  1. Navigate to Admin > Business Admin > Studies or to a custom Study object tab and click into a Study record.
  2. In the Study Persons section, click Create.
  3. Select a Learner Role.
  4. Optional: Select a Study Country.
  5. Optional. Select a Study Site.
  6. Click Save.
  7. Repeat as necessary to assign additional Persons to the Study.

Once you add the Learner as a Study Person, the next time the training automation job runs, it will assign a set of training filtered down to their Study, Study Country, or Study Site.

Study Team Roles

The following are typical Study Team Role picklist values available for selection in Study Learner Roles or Study Curricula:

  • Principal Investigator
  • Subinvestigator
  • Regulatory Coordinator
  • Budgets and Contracts
  • External Inspector
  • Study Document Contributor - Blinded Content
  • Study Document Contributor - Unblinded Content
  • Study Viewer and Workflow Participant - Unblinded Content
  • Study Viewer and Workflow Participant - Blinded Content
  • SSU Administrator
  • SSU Study Team - Blinded
  • SSU Contracts Lead
  • CRO Study Team Member
  • SSU Lead
  • SSU Legal
  • CRA - Blinded Content
  • Lead CRA - Blinded Content
  • Study Manager - Blinded Content
  • Central Monitor
  • CRA - Unblinded Content
  • Lead CRA - Unblinded Content
  • Study Manager - Unblinded Content
  • CTA - Blinded
  • CTA - Unblinded
  • Clinical Research Coordinator

Study Managers require a security profile with the following permissions to create and manage a Study Training matrix:

  • Read, Create, Edit, and Delete permissions for the following Study Training objects:
    • Study
    • Study Country
    • Study Site

  • Read, Create, Edit, and Delete permissions for the standard Training matrix objects.