Are you current and up to date with your training

ICH-GCP Training including E6R2 addendum

ICH-GCP states that it is the sponsors’ discretion as to how often you should be taking GCP training, several guidelines suggest every two years. However, in recent audit findings the Regulatory Authorities have found significant compliance issues in clinical trials due to insufficient training.

If you haven’t taken GCP training since the E6R2 update was implemented in June 2017, then you will have to familiarise yourself with the new changes to meet GCP requirements. Good news is you don’t have to fully re sit GCP you can just complete training on the update with proof that you have done so, along with your up to date GCP certificate. Depending on how long ago you took your GCP training it may well be worth retaking it as long as the training includes the update. Don’t forget to check your training is TransCelerate recognised so that it will be accepted by any sponsor you work with. More information can be found on their website http://www.transceleratebiopharmainc.com/

Medical Devices
The Medical Devices Regulations (MDR) implemented in June 2017 supersedes the previous Medical Device Directive (MDD) and outlines the regulatory requirements governing clinical trials involving medical devices. ISO14155:2011 addresses Good Clinical Practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices. Anybody working on or thinking about working on a device study should ensure they have up to date and comprehensive knowledge of the above regulations and guidance.

Essential Documents and Informed Consent
As GCP training only provides the basic framework of essential documents and informed consent, ensure that you are fully compliant by seeking additional in depth training in these two significant areas if you are working within the clinical research environment to ensure you are meeting GCP requirements.

Is your training up to date?
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