ISO GCP (ISO 14155) Refresher Training for Clinical Investigations with Medical Devices - eLearning - ECCRT
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ISO GCP (ISO 14155) Refresher Training for Clinical Investigations with Medical Devices – eLearning

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DateProductLocationPrice 
ISO GCP (ISO 14155) Refresher Training for Clinical Investigations with Medical DeviceseLearningEUR 250Book
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ISO14155

About this course

Reasons to attend 

As a monitor, project manager, or member of an investigator team, it is important to stay current on the ISO14155 Good Clinical Practice standard for clinical investigations involving medical devices and human subjects.

This 2-hour course will help refresh and update your knowledge of ISO-GCP, specifically the 2020 version, and provide guidance on how to comply with the standard in your clinical research activities.  

What's included?

  • Documents and materials related to this course are included
  • Globally recognised certificates awarded after test completion
 

Course schedule

  • 2-hour eLearning
 


Course description 

This 2-hour course on ISO-GCP is designed for professionals in the clinical research field, such as project managers, CRAs, medical monitors, field engineers, study coordinators, study nurses, and investigator teams, who need to refresh their knowledge of the latest ISO-GCP standard for conducting and documenting clinical studies with medical devices.  

The ISO14155 training covers all sections of the standard, including the distinct responsibilities of sponsors and investigators, and requirements for oversight and risk-based management. Real-life case studies, interactive quizzes, and "True/False" questions are included to reinforce understanding and awareness of key concepts and essential documents.  

The course also covers FDA observations on deviations that are considered violations and the use of digital tools, such as electronic informed consent, while maintaining GCP compliance. Common questions from practice are also answered to provide a comprehensive understanding of the rules and responsibilities outlined in the ISO-GCP standard. The training concludes with a final quiz, reviewing the key topics covered throughout the session. 

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