- Introduction (00:01:09)
- Clinical Investigation Planning (00:08:07)
- Monitoring Plan (00:05:29)
- Clinical Investigation Conduct (00:06:57)
- Document and Data Control (00:06:08)
- Suspension, termination and close (00:08:12)
ISO 14155 2020 Clinical Trial From Start To Finish
This tutorial provides an accurate overview of the main changes introduced by ISO 14155: 2020 for the Clinical Trial process. The clinical trial’s process is described from the beginning to the end: Planning, Conduct and Closeout.
Why take this course
To ensure and keep up-to-date on regulatory standards for clinical trials; To effectively apply investigation requirements for medical devices, and to better align clinical research procedures with those of the Good Clinical Practice (GCP) guidelines.
What I will learn
This tutorial provides an overview of the main changes introduced by ISO 14155: 2020 on different steps of the clinical investigation:
- Suspension, termination and close-out
Skills I will gain
You will be able to clearly understand the new requirements and identify those already provided by ISO 14155:2011 and confirmed by the new version of the standard.
- Final Test – ISO 14155 2020 Clinical Trials from Start to Finish
Only logged in customers who have purchased this product may leave a review.