Shared Responsibility Model
Shared Responsibility Model
Category: Best Practices | Audience: undefined | Page: 33 of 33
Table of Contents
- Accessing Sponsor Information
Shared Responsibility Model
Welcome to the Elixia Health clinical trial platform! Understanding the shared responsibility model is crucial for a successful and secure experience. This model outlines the responsibilities of both Elixia and the customer, ensuring a seamless and efficient trial management process.
Key Concepts
The shared responsibility model divides tasks and obligations between Elixia and the customer to optimize the use of the MCT (MyClinicalTrial) and MTJ (My Trial Journey) platforms. By clearly defining these responsibilities, we aim to enhance data security, compliance, and overall platform performance.
What You Can Do
As a user of the Elixia Health platform, you can:
- Manage trial participant recruitment and enrollment
- Ensure patient data accuracy and timeliness
- Track participant engagement and communication
- Conduct regular site visits and monitor trial progress
- Provide necessary documentation and reports
- Collaborate with Elixia’s Project Operations team for support
How To
Accessing Sponsor Information
Accessing Sponsor Information
To access sponsor information within the MCT application, follow these steps:
- Log in to the MCT application using your credentials:
- Navigate to https://mct.elixiahealth.com
- Enter your username and password
- Complete multi-factor authentication if required
- Verify you have "Sponsor View" or "Study Admin" permissions for the sponsor(s) you need to access
- Click on the "Sponsors" tab:
- In the main navigation menu, select "Administration" or "Studies"
- Click on the "Sponsors" tab to access the sponsor management interface
- You will see a list of all sponsors you have access to
- The list displays:
- Sponsor name and ID
- Primary contact information
- Number of active studies
- Current subscription status
- Last activity date
- Search for the sponsor you want to view by entering the sponsor name or ID:
- Use the search field at the top of the Sponsors list
- Enter any of the following to search:
- Sponsor Name: Full or partial company name (e.g., "Pharma", "ABC Pharmaceuticals")
- Sponsor ID: Unique sponsor identifier (e.g., "SPONS-001234")
- Contact Name: Sponsor contact person's name
- Email Address: Sponsor contact email domain
- Search is case-insensitive and supports partial matches
- Results update in real-time as you type
- Click on "Advanced Search" for more detailed filtering options:
- Filter by subscription status (Active, Inactive, Trial)
- Filter by geographic location
- Filter by therapeutic area
- Filter by number of studies
- Filter by contract end date
- Click on the sponsor's name to access their details page:
- The sponsor details page includes the following sections:
Basic Information:
- Company name and legal entity information
- Sponsor ID and type (Pharmaceutical company, CRO, Academic institution, etc.)
- Industry classification and therapeutic areas
- Headquarters location and multiple office locations
Contact Information:
- Primary contact (name, email, phone)
- Secondary contacts (billing, technical, legal)
- Account manager or relationship manager
- Support contact for different departments
Subscription and Services:
- Current subscription plan and tier
- Active services and modules:
- MCT Core Platform
- MTJ Patient App
- Advanced Analytics
- Custom Integrations
- Premium Support
- Subscription start and end dates
- Auto-renewal status
- Billing information
Active Studies:
- List of all studies owned by this sponsor
- Study status (Active, Completed, On Hold)
- Number of enrolled participants per study
- Last activity date
- Study manager or principal investigator
- Link to view study details
Compliance and Certifications:
- HIPAA compliance status
- GDPR compliance status
- FDA Part 11 compliance
- SOC 2 Type II certification
- Last audit date
- Upcoming audit schedule
Data Summary:
- Total data storage used
- Storage quota and remaining space
- Data retention policies
- Backup and recovery information
- Archival status
Recent Activity:
- Last login date
- Recent user activities
- Recent changes to studies or data
- Support tickets opened
- System alerts or notifications
- Review Detailed Sponsor Information:
- Edit Sponsor Details (if you have Admin permissions):
- Click "Edit" button to modify sponsor information
- Update contact information, addresses, or billing details
- Save changes and system records the modification date
- View Studies Associated with Sponsor:
- Click on individual studies to view details
- Review study status, enrollment, and compliance
- Access study-specific reports and analytics
- Manage Sponsor Users:
- View all users associated with the sponsor
- Add or remove users
- Assign roles and permissions
- Review user activity logs
- Configure Sponsor Settings:
- Set data retention policies
- Configure notification preferences
- Manage API access and integrations
- Set security and compliance requirements
Managing Participant Data
To ensure participant data is up-to-date and accurate:
- Log in to the MTJ application:
- Navigate to https://mtj.elixiahealth.com
- Enter your credentials (Site Coordinator, Study Coordinator, or Study Manager)
- Complete multi-factor authentication if required
- Verify you have permissions for the study/participants you need to manage
- Navigate to the "Participants" section:
- Click on "Participants" in the main navigation menu
- Or navigate to "Studies" > [Study Name] > Participants
- You will see a list of all enrolled participants for your study(ies)
- The participant list displays:
- Participant ID and initials
- Enrollment status (Screened, Enrolled, Active, Completed, Withdrawn)
- Age and demographic information
- Site location
- Enrollment date
- Last visit/activity date
- Use filters to view specific participant groups:
- Filter by enrollment status
- Filter by site/location
- Filter by visit schedule status
- Filter by visit windows (overdue, upcoming, completed)
- Filter by data entry completeness (complete, incomplete)
- Review and update participant information as needed:
Participant Demographics:
- Legal Name: First, middle, last name (as provided during informed consent)
- Participant ID: Unique identifier assigned by study (cannot be changed)
- Date of Birth: Used for age eligibility and safety monitoring
- Gender/Sex: Male, Female, Non-binary, Prefer to specify
- Race/Ethnicity: Self-reported demographic information per regulatory requirements
- Contact Information:
- Primary phone number (mobile or home)
- Secondary phone number (alternate contact)
- Email address (for electronic notifications if consented)
- Preferred contact method (phone, email, mail)
Clinical Information:
- Informed Consent Status: Consent date, version consented to, consent form signature
- Inclusion/Exclusion Criteria Assessment: Documented confirmations
- Medical History: Relevant past medical conditions, surgeries, medications
- Current Medications: All medications currently taking (including over-the-counter and supplements)
- Allergies: Drug allergies and reaction severity
- Vital Signs Baseline: Height, weight, blood pressure from baseline visit
- Lab Values: Baseline laboratory results if applicable
Enrollment and Status:
- Screening Date: When participant underwent screening
- Enrollment Date: When participant was officially enrolled
- Current Status: Active, completed, withdrawn, etc.
- Reason for Withdrawal (if applicable): Non-compliance, adverse event, etc.
- Withdrawal Date: Date participant exited the trial
- Follow-up Status: Any post-trial follow-up required
Visit Schedule and Completion:
- Scheduled Visits: List of all planned visits with dates and visit windows
- Visit type (screening, baseline, week 4, week 8, etc.)
- Scheduled date and acceptable visit window (e.g., ±3 days)
- Visit status (Scheduled, Completed, Missed, Rescheduled)
- Visit Data:
- Visit completion date
- Assessments or forms completed during visit
- Any adverse events or observations
- Next visit scheduled date
Data Entry Fields:
- Identify incomplete or missing data:
- Red or yellow indicators show required fields not completed
- System prevents closing forms with required missing data
- Hover over fields to see data requirements
- Common data entry updates:
- Updating visit dates if visits were rescheduled
- Adding clinical observations from recent visits
- Documenting adverse events or protocol deviations
- Recording medication changes
- Updating contact information if participant moved
- Data entry best practices:
- Enter data as soon as possible after visit (within 24 hours preferred)
- Double-check data entry for accuracy
- Use standardized codes and terminologies
- Document source of data (medical record, direct questioning, etc.)
- Record who entered the data and when
Data Validation:
- System performs automatic validation checks:
- Age calculations from date of birth
- Range checks (values outside normal ranges flagged)
- Logical consistency checks (e.g., end date after start date)
- Required field validation
- Format validation (phone numbers, dates, etc.)
- Manual review for data quality:
- Review flagged data for accuracy
- Correct errors or clarify with participant if needed
- Document correction reason and date
- Query resolution with source documents
Compliance and Audit Trail:
- All data changes are logged with:
- Who made the change (username)
- When the change was made (timestamp)
- What was changed (before and after values)
- Reason for change (if required)
- Access controls ensure only authorized personnel see participant data:
- Site coordinators see only participants from their site
- Study monitors see all participants in their assigned study
- Sponsors may have read-only or full access depending on role
- Patient data is never visible to unauthorized users
- Save changes to ensure data integrity:
- After updating participant information, click "Save" button
- System validates all required fields are complete:
- If validation errors appear, review and correct them
- System highlights specific fields with issues
- Upon successful save:
- Confirmation message appears ("Changes saved successfully")
- Data is written to the database with timestamp
- Audit trail entry is created
- Last modified date is updated
- Scheduled auto-save (optional):
- Enable auto-save to capture changes every 5 minutes
- Helpful for long data entry sessions
- You will still need to click Save to finalize
Data Synchronization:
- If using offline mode, sync data when connection restored:
- Click "Sync with Server" button
- System uploads offline changes to server
- Downloads any updates from other users
- Resolves conflicts if same data was modified elsewhere
Data Backup:
- MTJ automatically backs up data:
- Real-time replication to backup database
- Daily full backups retained for 30 days
- Weekly backups retained for 90 days
- Monthly backups retained for 7 years
- You can request a data export for:
- Migration to new system
- Archival after trial completion
- External analysis or sharing
- Quality Assurance and Compliance:
- Data Quality Checks:
- Run regular data quality reports
- Identify missing or inconsistent data
- Follow up with sites on data quality issues
- Address discrepancies promptly
- Privacy and Security:
- Never share passwords or access credentials
- Log out when leaving workstation unattended
- Use secure network connections (avoid public WiFi)
- Report suspicious access or data concerns
- Regulatory Compliance:
- Ensure all participants have valid informed consent
- Maintain confidentiality of participant information
- Follow protocol requirements for data collection
- Document all protocol deviations
- Maintain audit trail for regulatory inspection
Tips & Best Practices
Next Steps
- Review the User Guide: Familiarize yourself with the Elixia Health platform’s features and functionality.
- Contact Technical Support: Reach out to Elixia’s technical support team for any questions or concerns regarding the platform.
- Schedule Training: Arrange a training session with Elixia’s training team to gain hands-on experience with the platform.
By understanding and adhering to the shared responsibility model, you’ll be well-equipped to manage your clinical trials effectively and ensure a successful trial execution.
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