Overview
ClinicalDataS implements a hierarchical Role-Based Access Control (RBAC) model that organizes user roles into three distinct levels: System, Study, and Site. This structure ensures that users only have access to the data and functions necessary for their responsibilities, following the principle of Least Privilege.
System Level Roles
System-level roles have platform-wide access and are responsible for the overall management, configuration, and security of the ClinicalDataS platform.
| Abbreviation | Role Name | Responsibilities |
|---|---|---|
| SA | System Administrator | Manage all studies, users, and system configurations. Configure platform-wide settings (URL, branding, email, S3 storage). Manage authentication policies (password rules, 2FA, session timeouts). Oversee audit logs, email logs, and system security. Assign and manage system-level roles. Access all modules and data across all studies |
Note: The System Administrator is the only role with unrestricted access to the System Settings module and the Administrations dashboard.
Study Level Roles
Study-level roles are assigned at the study level and have access to data and functions across all sites within a specific study. These roles are typically held by Sponsor, CRO, or central team members.
| Abbreviation | Role Name | Responsibilities |
|---|---|---|
| STA | Study Administrator | Configure study parameters, events, CRFs, and applications. Manage study-level users and site assignments. Install/uninstall study applications (Randomization, IMP, Survey, etc.). Oversee study setup and Go-Live process. Access study-wide reports and dashboards |
| SD | Study Director | Oversee the overall conduct and scientific integrity of the study. Review and approve critical study decisions. Access comprehensive study data and reports. Typically holds a senior scientific or medical role |
| SS | Study Sponsor | Represent the sponsoring organization. Monitor study progress and compliance. Access study-wide data and financial reports. Approve major study milestones |
| SPM | Sponsor Manager | Manage day-to-day study operations on behalf of the Sponsor. Coordinate with sites, monitors, and data managers. Review study progress and resolve issues. Access study-wide dashboards and reports |
| SDM | Sponsor Data Manager | Oversee data quality and integrity across the study. Review and resolve queries at the study level. Manage dataset extraction and export. Oversee medical coding and data validation |
| SSM | Sponsor Supply Manager | Oversee the clinical supply chain (IMP) at the study level. Manage warehouse operations and drug distribution. Approve site delivery requests and monitor inventory. Oversee IMP waste management and returns |
| SIM | Sponsor IP Code Manager | Manage IP code generation, assignment, and randomization lists. Oversee randomization configuration and unblinding requests. Access unblinded data and randomization reports. Typically an unblinded role with restricted access |
| STM | Study Monitor | Perform remote or centralized monitoring activities. Review data quality, SDV status, and query resolution. Generate monitoring visit reports. Identify and escalate protocol deviations and SAEs |
| MS | Monitoring Sponsor | Oversee monitoring activities on behalf of the Sponsor. Review monitoring visit reports and issue resolution. Ensure monitoring compliance with study protocols. Access study-wide monitoring dashboards |
| PM | Project Manager | Coordinate study timelines, resources, and deliverables. Track study progress and manage risks. Coordinate between Sponsor, CRO, and sites. Access study-wide reports and dashboards |
| MM | Medical Monitor | Provide medical oversight for the study. Review safety data, SAEs, and protocol deviations. Approve unblinding requests when medically necessary. Ensure subject safety and regulatory compliance |
| SC | Study Coder | Perform medical coding of verbatim terms (AE, Medical History, etc.). Manage coding aliases and dictionary mappings. Review and resolve coding queries. Ensure coding consistency across the study |
| SE | Study Evaluator | Evaluate study data and outcomes. Perform data analysis and review statistical reports. Access study-wide data for evaluation purposes. Typically involved in interim analyses or endpoint adjudication |
| Reviewer | Reviewer | Review study data, documents, or reports. Read-only access to assigned study data. Provide feedback or approval on reviewed items. Typically used for external reviewers or auditors |
Site Level Roles
Site-level roles are assigned at the site level and have access limited to the data and functions relevant to their specific research site. These roles are typically held by site staff.
| Abbreviation | Role Name | Responsibilities |
|---|---|---|
| Investigator | Principal Investigator (PI) | Oversee the conduct of the study at the site. Ensure regulatory compliance and subject safety. Review and sign CRFs, consent forms, and key documents. Approve site-level decisions and delegate tasks to CRCs. Access all site-level data and reports |
| CRC | Clinical Research Coordinator | Perform day-to-day study operations at the site. Screen, enroll, and manage study subjects. Enter clinical data into CRFs. Manage subject files and consent documentation. Respond to queries and perform data corrections. Coordinate with monitors and the study team |
| SM | Site Monitor | Perform on-site monitoring visits. Conduct Source Data Verification (SDV). Review informed consent and regulatory documents. Identify and report protocol deviations. Generate monitoring visit reports |
| SP | Site Pharmacist (Blinded) | Manage IMP inventory at the site. Dispense IMP to subjects according to randomization. Track drug accountability and lot/serial numbers. Process IMP waste and returns. Blinded role: Cannot view treatment assignment |
| UP | Unblinded Pharmacist | Manage IMP inventory with access to unblinded data |