What does the ISO 14155 course cover?
ISO 14155 is covered here in 15 modules: Introduction to ISO 14155: Key concepts and terminology, Clinical Investigation Planning: Establishing a data management plan, Clinical Investigation Design: Blinding and masking techniques and 12 more. The outline lists 74 specific topics, opening with overview of ISO 14155 and its importance in medical device clinical investigations and closing with Maintaining EDC and CDMS records.
How do you approach ISO 14155 step by step?
The work is sequenced in 15 stages. It starts with introduction to ISO 14155: Key concepts and terminology, moves through Clinical Investigation Planning: Establishing a data management plan and Clinical Investigation Design: Blinding and masking techniques, and ends at Electronic Data Capture and Clinical Data Management Systems. Each stage carries its own topic list, so the sequence is followed rather than summarised.
What is in Module 1 of the ISO 14155 course?
Module 1 is Introduction to ISO 14155: Key concepts and terminology. It works through overview of ISO 14155 and its importance in medical device clinical investigations, history and development of the standard, key concepts and terminology and 1 more. It sets the vocabulary the remaining 14 modules build on.
How is the ISO 14155 course delivered?
The ISO 14155 course is fully self-paced with immediate online access after enrolment. Access does not expire and future updates are included at no cost. It can be taken on any device, and a certificate of completion is issued by The Art of Service when you finish.
How much does the ISO 14155 course cost?
The ISO 14155 course is $199 as a one time payment. There is no subscription, no per seat licence and no hidden fee. Enrolment carries a 30 day satisfied or refunded guarantee, so it can be assessed in full before you commit.
Closely related courses: ISO 14155 Masterclass, Clinical Investigation and Medical Device Regulation, ISO 14155 Clinical Investigations of Medical Devices.
More answers: what you get with every course, refund policy, all help answers.
Mastering ISO 14155: A Step-by-Step Guide to Medical Device Clinical Investigations
Course Overview
This comprehensive course provides a step-by-step guide to medical device clinical investigations, ensuring that you master the requirements of ISO 14155. Participants will receive a certificate upon completion, issued by The Art of Service.Course Features
- Interactive and engaging content
- Comprehensive and personalized learning experience
- Up-to-date and practical information
- Real-world applications and case studies
- High-quality content developed by expert instructors
- Certification upon completion
- Flexible learning options, including mobile accessibility
- User-friendly interface and community-driven discussions
- Actionable insights and hands-on projects
- Bite-sized lessons and lifetime access
- Gamification and progress tracking features
Course Outline
Module 1. Introduction to ISO 14155: Key concepts and terminology
- Overview of ISO 14155 and its importance in medical device clinical investigations
- History and development of the standard
- Key concepts and terminology
- Relationship with other standards and regulations
Module 2. Clinical Investigation Planning: Establishing a data management plan
- Defining the clinical investigation objective and scope
- Identifying the target population and selection criteria
- Determining the sample size and statistical analysis
- Developing a clinical investigation plan and protocol
- Establishing a data management plan
Module 3. Clinical Investigation Design: Blinding and masking techniques
- Types of clinical investigation designs (e.g., randomized controlled trials, observational studies)
- Control groups and comparator selection
- Blinding and masking techniques
- Randomization and stratification methods
- Crossover and parallel study designs
Module 4. Clinical Investigation Conduct: Maintaining participant safety and well-being
- Initiating the clinical investigation (e.g., site selection, investigator training)
- Conducting the clinical investigation (e.g., participant recruitment, data collection)
- Managing clinical investigation sites and personnel
- Maintaining participant safety and well-being
- Handling adverse events and serious adverse events
Module 5. Clinical Investigation Monitoring: Conducting on-site monitoring visits
- Defining monitoring responsibilities and requirements
- Conducting on-site monitoring visits
- Remote monitoring and centralized monitoring techniques
- Identifying and addressing monitoring findings
- Maintaining monitoring records and reports
Module 6. Clinical Investigation Data Management: Data analysis and statistical methods
- Data collection and data entry procedures
- Data validation and data cleaning techniques
- Data analysis and statistical methods
- Data storage and data security measures
- Data sharing and data publication guidelines
Module 7. Clinical Investigation Reporting: Creating tables, figures, and graphs
- Developing a clinical investigation report
- Writing a clinical investigation summary and conclusions
- Creating tables, figures, and graphs
- Documenting adverse events and serious adverse events
- Finalizing the clinical investigation report
Module 8. Clinical Investigation Close-out: Conducting a close-out visit
- Conducting a close-out visit
- Documenting close-out activities
- Ensuring participant follow-up and post-study care
- Maintaining study records and reports
- Reviewing and evaluating the clinical investigation
Module 9. ISO 14155 and Regulatory Compliance: ISO 14155 and FDA compliance
- Overview of regulatory requirements for medical device clinical investigations
- ISO 14155 and EU MDR compliance
- ISO 14155 and FDA compliance
- Other regulatory requirements and guidelines
- Maintaining compliance throughout the clinical investigation
Module 10. Audits and Inspections: Addressing audit and inspection findings
- Preparing for audits and inspections
- Conducting internal audits and self-assessments
- Hosting external audits and inspections
- Addressing audit and inspection findings
- Implementing corrective actions and preventive actions
Module 11. Risk Management and Quality Assurance: Conducting quality control activities
- Identifying and assessing risks in medical device clinical investigations
- Developing and implementing risk mitigation strategies
- Establishing a quality assurance program
- Conducting quality control activities
- Maintaining quality assurance and quality control records
Module 12. Ethics and Informed Consent: Maintaining informed consent records
- Principles of ethics in medical device clinical investigations
- Informed consent requirements and procedures
- Developing and reviewing informed consent forms
- Ensuring participant understanding and comprehension
- Maintaining informed consent records
Module 13. Clinical Investigation Personnel and Training: Conducting training sessions and evaluations
- Defining clinical investigation personnel roles and responsibilities
- Developing and implementing training programs
- Conducting training sessions and evaluations
- Maintaining training records and documentation
- Ensuring ongoing training and professional development
Module 14. Vendor Management and Outsourcing: Selecting and qualifying vendors
- Defining vendor management and outsourcing requirements
- Selecting and qualifying vendors
- Developing and implementing vendor management plans
- Conducting vendor audits and assessments
- Maintaining vendor management records and reports
Module 15: Electronic Data Capture and Clinical Data Management Systems
- Overview of electronic data capture (EDC) systems
- Clinical data management system (CDMS) requirements
- Developing and implementing EDC and CDMS plans
- Conducting EDC and CDMS training and support
- Maintaining EDC and CDMS records and reports