This comprehensive, self-paced 18 course suite provides you with all the necessary information, requirements and guidelines you need, including practical skills and tools to successfully accomplish medical device monitoring activities in compliance with Good Clinical Practices according to ISO 14155, 21 CFR part 812 and Japanese GCP for medical devices.
Through interactive multi-scenario case studies, glossary items, richly detailed charts, models and graphics, including audio and video presentations, you’ll uncover the fundamental processes, regulations, and techniques from the experts that will guide you throughout your career in medical device clinical investigations. Effective Monitoring of Medical Device Clinical Investigations was designed to get trainees up to speed and on the job quickly, efficiently and thoroughly.
Medical Device Clinical Investigations
Upon completion of this course, trainees will be able to correctly and successfully:
• Define the basic elements and objectives that compose Good Clinical Practice.
• Comprehend in detail the requirements as outlined in the Declaration of Helsinki.
• Interpret and apply the applicable regulations for GCP under ISO 14155.
• Explain the medical device regulatory environment in Europe and USA.
• Define and classify medical devices according to the Global Harmonization Task Force and major
• Illustrate the major stages involved throughout the development cycle of a medical device.
• Explain and apply medical device and clinical investigation terminology.
• Read and analyze a clinical investigation plan (CIP).
• Define roles and responsibilities within the process of writing a clinical investigation plan.
• Ensure and enforce a uniform understanding and strict adherence to the CIP requirements between all
parties involved within the clinical investigation to assure subject safety and reach objectives.
• Identify and implement the key elements that constitute the informed consent process and ensure full
compliance between all parties involved.
• Prepare and conduct ethics committee/IRB notifications in compliance with applicable rules and
• Carry out investigation site selection based on closely defined qualification criteria.
• Prepare and conduct detailed initiation visits using sound methods and follow-up techniques to ensure
optimal compliance throughout the duration of the clinical investigation.
• Identify and categorize an adverse event.
• Classify, document and report safety information concerning clinical investigations with respect to
applicable rules and regulations throughout Europe, United States and Japan.
• Prepare and conduct effective on-site periodic monitoring visits.
• Perform all necessary monitoring tasks and related logistics to ensure full compliance at all times.
• Set-up and manage a device accountability system and detect non-compliance issues through
establishing active verification methods and procedures.
• Identify deviations to the clinical investigation plan as well as regulatory requirements and apply the
necessary corrective and preventive actions including reporting requirements.
• Perform effective source document verification using organizational and relational skill sets.
• Ascertain the case report form process as well as data flow with paper and electronic data capturing
systems, including query processing to ensure appropriate traceability of all data points.
• Interpret and evaluate the essential contents and combined information sources that constitute
effective report writing.
• Guarantee full traceability of studies upon close down including the preparation, conduct and follow-up of close down visits as well as documenting lessons learned.
|Course Title Click on a title to view course description||ID||Duration|
|History of Good Clinical Practice (GCP)||1||15|
|Introduction to Good Clinical Practice||2||45|
|Introduction to Medical Device and Clinical Investigation Planning||18||45|
|The Clinical Investigation Plan||19||45|
|The Informed Consent Process||20||45|
|Ethics Committee(EC) / Institutional Review Board Requirements||21||40|
|Selecting Investigation Sites||22||45|
|Adverse Event Processes||24||77|
|The Periodic Monitoring Visit||25||120|
|Deviations and Non-Compliance Handling||27||15|
|Source Document Verification||28||30|
|The Case Report Form Process||29||45|
|Visit Report Writing||30||15|
|The Close Down Visit||31||30|
|Overview of Data Management Plan and Query Process||116||25|
|Good Documentation Practices for Clinical Study Files||117||45|