ISO 14155:2011- Scope
In this first course, we will cover the background of ISO 14155 and how to use it in conjunction with other regulatory documents worldwide. The ISO 14155 is applicable to all types of clinical investigations, you will get further clarification about this in this course. Last but not least, ISO has a number of important references, to other standards mandatory to apply when conducting clinical investigations, we explain more about this in this course.
After successfully completing this course, learners should be able to:
- Know when to apply the requirements of the ISO 14155
- Use ISO 14155 in conjunction with other regulatory documents worldwide
- Make risk averse decisions about exempting certain requirements from ISO 14155 for post market clinical investigations
- Use requirements of other standards and guidance documents in conjunction with those of ISO 14155.
Clinical research associates, clinical coordinators, clinical project managers, investigators, clinical trial assistants, data managers, data entry personnel, ethics committee members, institutional review board members, regulatory authorities and notified bodies personnel involved in auditing clinical evalutation.
An understanding of the history of GCP and what is GCP as well as overall requirements when conducting a clinical investigation is needed as outlined in the following courses :
- Medical Device GCP for Investigators (courses ID 193, 200, 212, 202, 204, 206) for hospital staff or for industry and other stakeholders,
- History of GCP (ID 41),
- Introduction to Good Clinical Practices (ID 42),
- Introduction to Medical Device and Clinical Investigation Planning (ID 43)