Study Personnel
A Study Person attaches a global-directory person to a study (and optionally a country/site) with a team role and dates. Create under Study Personnel & Communication → Study Personnel:
| Field | Notes |
|---|---|
| Person | The person (required); pick from the global directory or create inline |
| Full Name | Filled automatically |
| Study | The owning study (required) |
| Study Country / Study Site | Cascading study → country → site |
| Study Team Role | Team role (required): CRA, Lead CRA, Study Manager, CTMS Study Manager, Contributor, Central Monitor, CTA, etc. |
| Primary Contact Information | Main contact info (create inline) |
| Grant Access to Related Records | When checked, creates a User Role Setup granting access to related records |
| Start / End Date | Assignment dates |
Note
For access grants (URS) and role-based expected documents, see Study Personnel & User Role Setup. Use Make Inactive to remove someone from the team (access is cleared and the end date set automatically).
Teams can be refined to responsibilities: a Study Person Responsibility links a person to a study/country/site with a concrete responsibility (Principal Investigator, Subinvestigator, Clinical Research Coordinator, Regulatory Coordinator, Pharmacist, Study Nurse, and 10 seeded responsibilities in total), maintained on the person detail page.
Study Organizations
A Study Organization records which organizations participate in a study (optionally down to country/site). Create under Study Personnel & Communication → Study Organizations:
| Field | Notes |
|---|---|
| Organization | The organization (required); pick from the global directory or create inline |
| Study | The owning study (required) |
| Study Country / Study Site | Optional, cascading |
| Location | Organization location (filtered by the chosen organization) |
| Primary Payee | Whether this is the primary payee |
| Start / End Date | Participation dates |
Organizations can also be created from the Study Organizations sections on Study / Study Country / Study Site detail pages; the organization detail's Study Participation section shows all studies it participates in.
Study Communication Log
The Study Communication Log records communications with sites and study personnel (calls, emails, faxes, letters) as an auditable trail. Two types:
| Type | Notes |
|---|---|
| Site Communication (default) | Site communication; study/country/site and contact are required |
| Other Communication | Other communication; levels and contact are optional |
| Field | Notes |
|---|---|
| Communication Type | Required: Call / Email / Fax / Letter / Other |
| Primary Communication With | Main contact (e.g. the principal investigator) |
| Responsible Person | Responsible person (required) |
| Contact Date | Date/time of initial contact |
| Description | Summary (required, ≤75 chars) |
| Detail | Details (helps auditors understand purpose and outcome) |
| Related Inquiry | Links related exchanges into a communication chain |
Entry points: the Study Site Communications section on the Site detail page (site communications); the corresponding sections on Study / Study Country detail pages (other communications); and this sub-tab's list. Communication records can be referenced by a protocol deviation's Related Communication field.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| No Principal Investigator in the role list | Roles come from Study Team Role master data and can be extended by admins; PI/Sub-I roles additionally trigger expected-document generation |
| Can't pick a CRO/IRB type for organizations | This version does not enumerate organizations by Sponsor/CRO/Site; express it via Organization Type (e.g. Institution) and Primary Payee |
| Communication log validation fails | Site Communication requires study/country/site and contact; use Other Communication for non-site exchanges |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Study Person: Create, Read, Edit | Maintaining the study team (no delete — use Make Inactive) |
| Object | Study Organization: Create, Read, Edit | Maintaining participating organizations |
| Object | Study Communication Log: Create, Read, Edit | Recording communications |
CTMS Study Manager, CRA, and Central Monitor maintain teams and communications; CTMS Business Administrator can delete records; Document Contributor is read-only.