In Clinical Operations Vaults, you can track the internal processes of Investigator Initiated Studies (IIS) by utilizing data already in your Vault. Use the Investigator Initiated Studies tab to track proposal review and approval, study planning and execution, publications, and documents.

Investigator Initiated Studies require some configuration by an Admin for utilization in your Vault.

How To Create an Investigator Initiated Study

To create and edit investigator initiated studies:

• Navigate to the Investigator Initiated Studies tab.
• Click Create > Investigator Initiated Study to create a new record or click on an Investigator Initiated Study ID to edit an existing record.
• Enter a Study Title, select a Primary Product, and choose the Type of Support Requested.
• Enter additional details of the record as applicable. Depending on the configuration of your Vault, you may see additional sections and fields based on your entries.
• Click Save.

About 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.

Note that you can only add documents to an IIS record if the document type is assigned the Investigator Initiated Study shared field.

Related Permissions

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:

Type	Permission Label	Controls
Security Profile	Objects: Investigator Initiated Study: Create, Edit	Ability to create and edit Investigator Initiated Study records
Security Profile	Tabs: Investigator Initiated Studies: View	Ability to view and access the Investigator Initiated Studies tab on the navigation bar