The ISO14155 update was published in July 2020, providing guidance and requirements on how clinical data should be collected.
This 2-hour recorded session will focus on the impact of the updated ISO 14155 on clinical investigations and our daily work in clinical research.
This training was recorded in October 2019, and uses ISO/DIS 14155: 2018 as a reference. Since no changes of big importance on the requirements itself (only some wording, title and style changes) were made in the final ISO 14155:2020 version, this training is perfectly suitable to ensure you are updated on & ready to apply the ISO 14155:2020 standard.
By the end of this TRIUM Training you should be able to:
- Describe the key changes to the ISO 14155 standard and how they align or differ from ICH GCP E6 R2
- Assess the impact of these changes to your daily research reality
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.