Organizations
An Organization is master data for companies/institutions/sites, referenced by studies via Study Organization. Maintain under Global Directory → Organizations:
| Field | Notes |
|---|---|
| Organization | Organization name (required, unique) |
| Organization Type | Organization type (object type), e.g. Institution |
| Parent Organization | Parent organization (self-reference) |
| Status | Active / Inactive (lifecycle-driven) |
The Study Participation section on the detail page shows every study the organization participates in; organizations can also be created inline from the Study Organizations section on the study detail (see Study Personnel & Communication).
Products
A Product is master data for the active ingredient or asset used in a study. Maintain under Global Directory → Products: Product Name (required, unique), Status, External ID. Products attach to a study through a Study Product — created from the Studies section on the Product detail page or the Study Products section on the Study detail page, with the product's role in that study (below).
Study Product Roles
A Study Product Role defines the role a product plays in a study; five are seeded:
| Role | Meaning |
|---|---|
| Lead Agent | Lead (investigational) agent |
| Comparator Agent | Comparator agent |
| Placebo | Placebo |
| Device | Device |
| Diagnostic | Diagnostic product |
Pick the Study Role when creating a Study Product to express "what this product does in this study".
Personnel
A Person is the global directory of people — investigators, site staff, vendor personnel, internal personnel, and IRB/IEC members — and the source for the study team (Study Person). Maintain under Global Directory → Personnel:
| Field | Notes |
|---|---|
| First / Last Name | First / last name (required) |
| Email (required) | |
| Person Type | Object type: Internal (default), Investigator, Site Staff, Vendor, IRB/IEC |
| Vault User | Links a Vault user (unique); shared fields stay in sync |
| Manager | Manager (self-reference) |
| External ID / CDX ID / Global ID | Integration mapping fields |
| Debarred / Key Opinion Leader / NPI Number | Compliance and profile flags |
The Study Participation section shows the person's study team records; Contact Information holds contact details. Run Promote to User to promote a person to a Vault user. The Study Person's person field can create a Person inline (see Study Personnel & Communication).
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Same organization/person registered in many studies | Keep master data in the global directory; reference it from studies via Study Organization / Study Person |
| Promote to User not visible | Confirm the person isn't linked to a Vault user yet and you hold the permission |
| Can't find a product | Create it under Global Directory → Products first, then attach it to the study from the Study Products section |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Organization / Product / Study Product Role / Person: Create, Read, Edit | Maintaining global directory master data |
CTMS Study Manager can create organizations (Institution / IRB-IEC / Sponsor / Vendor types), products, product roles, and all person types; CRA and Central Monitor are mostly read-only; deletion is limited to CTMS Business/System Administrators.