CTMS Domain Model
The following list represents the core entities within the Clinical Trial Management System (CTMS).
Entity Overview
| Entity | Description |
|---|---|
| Study | A clinical trial with protocol details, phase, type, and status. Contains Sites, Subjects, Personnel, and CRF Forms. |
| Site | A trial location where the study is conducted. Has a Site Location and Site Status. Linked to Healthcare Practitioners. |
| Subject | A participant enrolled in a study. Is linked to a Patient and assigned to a Study Coordinator. |
| Patient | An individual with demographics and health history. May participate in multiple studies as a Subject. |
| Healthcare Practitioner | A physician or investigator. Can be a Principal Investigator or Study Coordinator for a study. |
| Study Event | Scheduled visits or milestones within a study protocol (e.g., Screening, Week 1, End of Study). |
| CRF Form | Case Report Form for data collection. Linked to Study, Subject, and Study Event. |
| Consent | Patient consent records for study participation. |
| Patient Encounter | A clinical visit/interaction. Contains Vitals, Prescriptions, and Lab Tests. |
| Vitals | Vital sign measurements recorded during encounters (BP, HR, Temperature, etc.). |
| Adverse Events | Safety events reported during the study with severity classification. |
| Physical Examination | Clinical examination findings recorded for a subject. |
| Family Medical History | Patient's family health history relevant to the study. |
Entity Relationships
Study Hierarchy
Study
├── Sites (Trial locations)
├── Subjects (Enrolled participants)
├── Study Personnel (Coordinators, Investigators)
├── Study Events (Protocol milestones)
└── CRF Forms (Data collection forms)
Subject Relationships
Subject
├── Patient (Demographics, Health History)
├── Consent (Participation agreement)
├── Study Coordinator (Assigned personnel)
├── Encounters
│ ├── Vitals
│ ├── Physical Examination
│ └── Prescriptions
├── Adverse Events
└── CRF Data (Per Study Event)
Master Data
Master Entities
├── Study Type (Interventional, Observational)
├── Study Phase (Phase I, II, III, IV)
├── Study Status (Active, Completed, Suspended)
├── Site Location
├── Site Status
├── Event Type
├── Dosage Form
├── Prescription Dosage
└── Item (Drugs, Laboratory Tests)
Core Entities
Study
The central entity representing a clinical trial.
| Field | Description |
|---|---|
study_name | Protocol/study title |
study_code | Unique protocol identifier |
phase | Trial phase (I, II, III, IV) |
type | Interventional or Observational |
status | Active, Recruiting, Completed, etc. |
expected_start_date | Planned start date |
expected_end_date | Planned end date |
expected_no_of_participants | Target enrollment |
Subject
A patient enrolled in a specific study.
| Field | Description |
|---|---|
subject_id | Unique subject identifier |
patient | Link to Patient entity |
study | Link to Study entity |
study_coordinator | Assigned coordinator |
enrollment_status | Screening, Enrolled, Completed, Withdrawn |
Adverse Event
Safety event reported during the study.
| Field | Description |
|---|---|
subject | Link to Subject |
study | Link to Study |
event_term | AE description |
severity | Mild, Moderate, Severe |
serious | Is Serious AE (SAE) |
outcome | Resolved, Ongoing, etc. |
CRF Form
Custom data collection form for a study.
| Field | Description |
|---|---|
study | Link to Study |
subject | Link to Subject |
study_event | Link to Study Event |
| Custom fields | Defined per form design |
Next Steps
- Sublink Domain Model - Mobile app entities
- Study Design - How to create a study
- Creating e-CRFs - CRF form design