Streamlined Patient Data Tracking for Clinical Trials
Enhance your research study management by integrating comprehensive clinical data directly into participant records. This functionality provides study coordinators with immediate access to critical medical information while maintaining strict compliance standards.
Key Benefits
- Centralized patient profiles with all relevant clinical data
- Real-time eligibility assessment for study matching
- Automated data processing for participant enrollment
- Regulatory-compliant tracking of medical history
Implementation Requirements
System Configuration
| Requirement | Details |
|---|---|
| Edition | Lightning Experience |
| License | Enterprise/Unlimited with: • Life Sciences Cloud or • Health Cloud + Participant Enrollment Add-On |
| Permissions | • Clinical Trial Manager (full access) • Clinical Trial Coordinator (view/add) |
Clinical Data Objects Overview
Organize patient medical information using these standardized objects:
Core Patient Data
- Account (Patient)
- Clinical Encounter
- Diagnostic Summary
Medication Tracking
- Medication
- Medication Request
- Patient Medication Dosage
Medical History
- Allergy Intolerance
- Health Condition
- Patient Health Reaction
- Patient Immunization
- Patient Medical Procedure
Observational Data
- Care Observation
- Care Observation Component
- Clinical Service Request
Step-by-Step: Adding Clinical Data
- Access the Object
- From App Launcher, select the relevant clinical object (e.g., “Allergy Intolerances”)
- Create New Record
- Click New button
- Complete all required fields (marked with *)
- Populate optional fields for enhanced tracking
- Save & Utilize Data
- Save to automatically update:
- Patient lightning pages
- Candidate Matching algorithms
- Research Study Evaluation prompts
- Save to automatically update:
Advanced Integration Features
Automated Processing
Clinical data automatically feeds into:
- Prepare Candidate Details engine
- Participant Enrollment workflows
- Eligibility Assessment tools
Cross-Functional Visibility
- Site coordinators see consolidated health data
- Researchers access filtered information by study parameters
- Compliance officers monitor complete audit trails
Best Practices
- Standardize Data Entry
- Use predefined picklist values where available
- Establish naming conventions for free-text fields
- Maintain Compliance
- Regularly review HIPAA/GCP access logs
- Utilize field-level security for sensitive data
- Leverage Automation
- Set up validation rules for critical health data
- Create alerts for abnormal clinical values
“Proper clinical data management reduces participant screening time by 40% while improving study compliance.”
— Journal of Clinical Research, 2023
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