As most of you already know, we are closely working with Training or Quality Assurance Managers at clinical research and pharma companies that use Astra Nova’s training services. One of the key courses they need is the Good Clinical Practice training.
NB! You can read more about the ICH GCP training and the different online and in-house versions here: https://crotraining.co.uk/should-i-choose-good-clinical-practice-online-training-or-a-seminar/
Number one question I receive is: Do you certify people with your Good Clinical Practice courses and what value these certificates have. So, here are some insights of this topic:
- ICH GCP certification mandatory: Certificate in Good Clinical Practice is one of the key requirements in order for a professional be allowed get involved in clinical trials. Besides being international guidance, in many countries ICH GCP lies in the local laws and regulations. This certification became also an industry standard because many of the sponsors are responsible for the quality and safety of their clinical research projects. In this sense many of them are making sure that every single individual has passed a Good Clinical Practice training and has the proof for that- the certificate.
- How often do we need to get certified?: This is very relative question and it depends on two main factors: location and company. There are some countries like the UK where it is required to pass a Good Clinical Practice training every 2 years, but in countries like Germany it is recommended to do this even every year. This often comes from the private company and their training traditions. Most of the pharma corporations prefer to have ICH GCP training every year too, where they have a basic course the first year and then organize workshops to cover more practical aspects and internal company’s cases.
- Value of certificates: Whether a certificate is approved or not depends also on many things. The first question you have to ask yourself in order to find the answer is who might be looking at the certificate so that you know their expectations. Here are some core principles of how the certificate should look like and how you can determine its real value:
– Date of successfully passing an exam;
– Your names (sometimes the name of the company, but it is not required);
– Agenda– very important- what has been covered within the training;
– Duration of the course (sometimes this duration might different than it really took you to pass the training, but this duration like on Astra Nova certificates has been evaluated by a third party organization that has accredited our ICH GCP online courses (Good Clinical Practice);
– Logo of the organisations that have accredited and approved the training; (Usually this means that the company that has created the training has also the documents to prove this if necessary)
– Logo of the company that has created the training;
I hope this will be helpful to you again and I am glad to hear your experiences with ICH GCP certification.
Maya Zlatanova, Business Development & Training Director at Astra Nova Ltd.
