Certified Clinical Investigation Specialist (CCIS) Certification Program by Tonex
Certified Clinical Investigation Specialist equips professionals to plan, conduct, and oversee clinical investigations aligned with ISO 14155:2020. Participants master ethical principles, protocol development, subject safety, data integrity, monitoring, and reporting across device trials. Emphasis is placed on risk-based quality management and defensible documentation that stands up to sponsor and regulatory scrutiny.
Digital systems are addressed with practical controls for eSource, EDC, and remote processes. Cybersecurity considerations are integrated to protect subject privacy and clinical data across connected devices and cloud workflows. Participants learn how cybersecurity threats can compromise data integrity and safety reporting and how to embed secure-by-design practices in study operations.
Learning Objectives
- Apply ISO 14155 principles to clinical investigations
- Design robust protocols and statistical endpoints
- Implement risk-based monitoring and quality plans
- Protect human subjects and ensure informed consent
- Manage data integrity across eSource and EDC
- Prepare audit-ready documentation and submissions
- Incorporate cybersecurity safeguards to protect data and privacy
Audience
- Clinical research associates and monitors
- Clinical project managers and leads
- Regulatory affairs specialists
- Quality assurance and compliance officers
- Biostatisticians and data managers
- Medical device R&D professionals
- Cybersecurity Professionals
Program Modules
Module 1: Good Clinical Practice Foundations
- ISO 14155 scope and structure
- Roles and responsibilities
- Ethics and subject protection
- Protocol and amendments
- Safety reporting overview
- Documentation hierarchy
Module 2: Protocol Design and Statistics
- Objectives and endpoints
- Study design selection
- Randomization and blinding
- Sample size rationale
- Statistical analysis plan
- Deviations and handling
Module 3: Risk Based Quality Management
- Risk identification methods
- Critical to quality factors
- Monitoring strategy design
- Key risk indicators
- CAPA integration flow
- Vendor oversight controls
Module 4: Site Startup and Monitoring
- Site selection criteria
- Feasibility and budgets
- Investigator meeting essentials
- Source data verification
- Remote monitoring tactics
- Closeout and reconciliation
Module 5: Data Management and Integrity
- eSource and EDC setup
- Data standards and CDISC
- Query and edit checks
- Audit trail requirements
- Data transfers and locks
- Archiving and retention
Module 6: Safety, Privacy, Cybersecurity
- Adverse event management
- Device incident handling
- Privacy and deidentification
- Secure system validation
- Cybersecurity risk controls
- Breach response coordination
Exam Domains
- Clinical Ethics and Subject Protection
- Protocol Architecture and Endpoint Strategy
- Risk Based Monitoring and Quality Control
- Data Integrity and Records Management
- Safety Management and Regulatory Reporting
- Digital Systems Governance and Cybersecurity
Course Delivery
The course is delivered through a combination of lectures, interactive discussions, and project-based learning, facilitated by experts in the field of Certified Clinical Investigation Specialist. Participants will have access to online resources, including readings, case studies, and tools for practical exercises.
Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified Clinical Investigation Specialist.
Question Types
- Multiple Choice Questions (MCQs)
- Scenario-based Questions
Passing Criteria
To pass the Certified Clinical Investigation Specialist Certification Training exam, candidates must achieve a score of 70% or higher.
Advance your expertise in ISO 14155 and safeguard clinical quality and data integrity—enroll in the CCIS program by Tonex today and drive compliant, secure clinical investigations.