ICH is the abbreviation for International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. The ICH is an international body that sets the standard which becomes regulations for clinical trials involving human subjects. The ICH sets the standard that defines the guidelines for Good Clinical Practice (GCP).
GCP is an international standard that ensures that ethical and scientific qualities are maintained in the designing, recording and reporting of clinical trials involving human subjects.
The aim of this regulatory standard is to ensure that the well-being, right and safety of the human beings recruited for clinical trials are protected. It also aims to ensure that data gotten from clinical trials are accurate, reliable and credible, irrespective of wherever or whatever clinical research facility that the trials are being conducted in the world.
ICH GCP certification is a formal recognition of an individual's knowledge and competence in their ability to carry out applicable GCP guidelines under different circumstances.
It is important for all professionals in the clinical research industry to get the much needed training in Good Clinical Practice (GCP) and be certified as well. As a matter of fact, most companies now take measures to ensure that their staff are GCP certified. Being GCP certified has become a minimum requirement for anyone who would like to explore a career in the area of clinical research.
Although all clinical research professionals are required to be GCP certified, GCP certification is of more importance to the following individuals:
Investigators from drug companies, research centers, hospitals etc.
Ethics committee members.
Students that are interested in working in the clinical research industry.
It is highly recommended all over the world to get the Good Clinical practice (GCP) training and certification if you are a clinical research professional or you are aspiring to be one. That is the least acceptable standard to work in the clinical research industry. Beyond GCP certification being a required minimum for a clinical research professional. There are a few other reasons why you need the GCP certification. They include:
It is a global formal acknowledgement of an individual's professional eligibility to work as a clinical research professional.
In order for organizations involved in the business of clinical research to comply with the laid down industry guidelines and regulations, Good Clinical Practice (GCP) training is important for members.
GCP training equips the participants with the knowledge of the regulations that are applicable in clinical research.
Pharmaceutical and biotech companies, as well as contract research organizations recommend that their employees are GCP certified.
ICH GCP in today's clinical research world is now more important than ever. The evolution of medical science and the complexities of research process highlight the importance of guidelines that ensure that clinical research are carried out properly.