ISO 14155 training for Investigators

 

ISO 14155 training for Investigators

Clinical Operations Courses

You are requested to participate in a medical device trial? It is your first time or you need to refresh your certificate of ISO14155 training? You want to know your and the others responsibilities? This half-day training is designed to give theoretical and practical knowledge to medical doctors.

dates
location
language
11 Dec 2012 Brussels English
850,00 €
  • Full description & trainer
  • Programme highlights
  • Learning objectives
  • Workshops & extras
Full description

This half-day course introduces investigators to the ISO14155 standard. This standard is mandatory in Pre-Market studies but is very frequently followed in large Post Market release trials especially when the results of these trials are to be published in major medical journals.
The course will guide the trainees through the sections of this document. During this training, focus will be put on investigator-specific topics. In the last part of the training, investigators will be confronted with information retrieved from a large series of monitoring reports, clearly showing
what the main issues are detected during monitoring visits. A number of solutions will be discussed in order to cope with or avoid these issues.

Who should attend?

Clinical Investigators with short- to medium term experience.

Trainers
  • 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 identify frequently occurring issues and to be able to correct these mistakes