In Clinical Operations Vaults, you can track the internal processes of Investigator Initiated Studies (IIS) by utilizing data already available in your Vault. This feature is fully customizable to fit the specific needs of your organization.
Vault includes the following standard components by default to aide in your setup of Investigator Initiated Studies:
- Investigator Initiated Study object with standard object fields, a custom page layout, and custom layout rules
- Investigator Initiated Study Documents document type
- Investigator Initiated Study shared document field
- Investigator Initiated Study tab
- Investigator Initiated Study Lifecycle with standard lifecycle states
- IIS External User security profile and IIS External User Actions permission set
Note: This feature is only available in Clinical Operations Vaults.
Investigator Initiated Studies functionality is available in all Clinical Operations Vaults but requires some configuration for utilization:
- Configure Investigator Initiated Study Documents.
- Update permission sets to grant users access to the Investigator Initiated Study object and navigation tab.
- Optional: Configure access for external IIS users.
- Optional: Customize the Investigator Initiated Study object by adding fields, modifying the page layout, and adjusting layout rules.
- Optional: Configure the Investigator Initiated Study Lifecycle to meet your organization’s business requirements.
- Optional: Configure workflows for the Investigator Initiated Study object to meet your organization’s business requirements.
- Optional: Configure Lifecycle Stages for the Investigator Initiated Study object.
Configuring Investigator Initiated Study Documents
Use the Investigator Initiated Study document type and document field to capture IIS-specific documents. For example, IIS budgets, contracts, principal investigator CVs, and protocols.
Activating the Investigator Initiated Study Documents Document Type
Activate the Investigator Initiated Study Documents document type to make it available to users. To do this:
- Navigate to Admin > Document Types and click on Investigator Initiated Study Documents.
- Select Activate from the Actions menu.
Assigning the Investigator Initiated Study Shared Field
Assign the Investigator Initiated Study shared field to document types in your Vault so that users can add those document types to IIS records. To do this:
- Navigate to Admin > Document Fields and click on the document type that you want to assign the shared field to.
- Click Add > Existing Shared Field.
- Select the Investigator Initiated Study option from the picklist
- Click OK.
Users can only add documents to an IIS record if the document type is assigned the Investigator Initiated Study shared field.
Configuring Investigator Access
Assign Investigators the IIS External User security profile with the IIS External User Actions permission set so that they can submit their proposals directly in your Vault. This access includes the ability to create Investigator Initiated Study records and to view IIS related records and documents in your Vault.
If additional permissions are needed, follow best practices to copy the standard permission set and assign custom permission sets to custom profiles.
If needed, configure groups and document permissions for external IIS users.
You can complete all steps in this article with the standard Business Admin, System Admin, or Vault Owner profile.
If your Vault uses custom security profiles, your profile must grant the following permissions:
Objects: Investigator Initiated Study: Create, Edit
Ability to create and edit Investigator Initiated Study records
Tabs: Investigator Initiated Studies: View
Ability to view and access the Investigator Initiated Studies tab on the navigation bar