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ISO 14155

Accredited with 10 CPD points recognised by the Institute of Clinical Research.
ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.

ISO 14155:2011 specifies

  • the general requirements intended to protect the rights, safety and well-being of human subjects
  • how to ensure the scientific conduct of the clinical investigation and the credibility of the results
  • the responsibilities of the sponsor and principal investigator
  • assists sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices

The clinical investigation process can be very costly if it is not carried out with the right methodology yet, to date, training on this important topic has been limited.

Clinical Research Training is pleased to announce a new web-based training programme focused specifically on ISO 14155:2011 so that your organisation has the most up to date information to understand the International Standard issued in February 2011 and know how and when to apply it.

This course is suitable for all personnel within the medical devices industry.

It has 3 sections covering the following topics:

  • General Requirements
    • Ethical considerations
    • Clinical Investigation Planning
    • Clinical Investigation Conduct
    • Suspension, termination and close-out of the clinical investigation
  • Responsibilities of the parties involved
  • Clinical Investigation documentation

How Do I Pay To Access The ISO 14155 Course?

If you are an individual there are 3 options:

  • If you have a credit card you can pay through the Paypal secure online payment terminal. Using this method will provide you with instant access to the course. You do NOT have to have a Paypal account to use this method, just a credit/debit card. To access the course by this method click here
  • You can also pay by credit/debit card over the telephone by calling us on +44 (0) 1204 488134 during BST/GMT office hours. You will need to provide us with a valid email address in addition to your cards details.
  • Alternatively you can download an order form and send it to us with your choice of payment method. To download the order form to your computer click here

If you are an organisation/company there is a 3 step process:

  • Download the order form from here
  • Complete the order form and send it to us either by post, email or fax. These details are on the order form.
  • The order form contains a payment options section and this can either be a company credit card, cheque or purchase order.

    • Access to the course will be provided once full payment has been made.
    Payments are processed by our partner Orbis Training and are made in accordance with their Privacy, Delivery, Refund and Cancellation Policies. These can be accessed through this link Policies.
    For questions relating to any of the above, please contact our Support Desk