ISO 14155:2020 - Clinical Investigation Planning
Course Description:
This course describes all activities involved in the clinical investigation planning process.
It covers the following topics:
- Risk assessment
- Justification of the investigational design,
- Clinical Investigation Plan (CIP),
- Investigator Brochure (IB),
- Case Report Form (CRF) requirements
- Monitoring plan,
- Site selection,
- Investigation agreements,
- Labeling requirements,
- Set up of data monitoring committee.
Learning Objectives:
Upon successfully completing this course, learners will be able to:
- Understand all necessary activities for the investigation planning phase
- Know that risk assessments and clinical evaluations are mandatory prior to starting clinical investigations
- Look up the content requirements of CIPs, IBs, and CRFs
- Establish justification for the extension of monitoring during clinical investigations
- Perform a thorough evaluation of investigation sites before committing to working with a given investigator
- Apply specific clinical investigation labeling requirements and be aware that these may vary from one region to another
- Consider whether a Data Monitoring Committee should be involved
Who Should Enroll:
Clinical research associates (monitors), clinical study coordinators, assistant senior clinical research associates, clinical project and data managers, data entry personnel, ethics committee and institutional review board members, regulators, and notified body personnel involved in auditing clinical evaluations are all welcome to participate in this course.
Prerequisite Knowledge/Requirements:
The following series is required:
- Effective Monitoring of Medical Device Clinical Investigations (IDs 41–48, 59, 56, 50–55, 108, 96)