ISO 14155 training for CRAs

 

ISO 14155 training for CRAs

Clinical Operations Courses

You are a monitor who needs to understand the counterpart of ICH-GCP for medical device trials. You want to know the rules and responsibilities outlined in ISO14155 and get some practical advice and hints and tips on improving your monitoring skills? This course is made for you and your colleagues!

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850,00 €
  • Full description & trainer
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Full description

This one day course brings starting CRAs and Investigators up to speed with the ISO14155, when working with device clinical trials. This standard is mandatory in Pre-Marketing studies but is very frequently followed in large Post-Marketing release trials especially when the results of these trials
are to be published in major medical journals.
Although comparable with ICH-GCP, the ISO14155 standard features a number of specific requirements, typical for device studies. This course will guide the trainees through all the sections of this document.
A quizz, covering the most important items will end the training day, offering the trainees a brief rehearsal on what has been discussed during the training.

Who should attend?

Recently started CRAs or Investigators and study co-ordinators.

Trainers
  • To understand the role of clinical studies in the development of devices
  • To be familiar with the basic requirements on how clinical trials are carried out
  • To appreciate the device-specific study elements as compared to drugs studies
  • To be familiar the participants with expected clinical tasks