Good Clinical Practice is an international quality standard provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (or ICH).
The latter is an international body, whose defined standards can be used by governments to transpose into regulations for clinical trials, involving human subjects.
Since 1995, ICH-GCP guidelines have become a global factor in c. research and have solidified their impact in traditional trial hubs, such as Japan, North America, and The EU. At the same time, their importance is growing perennially in developing regions.
Good Clinical Practice Guidelines include standards on how c. trials to be conducted, define the roles and responsibilities of trial sponsors, research investigators, and monitors (also known as CRA).
On the practical side, they are to be followed universally, in order to globally improve safety, efficiency, and communication between all parties involved within research and trials, i.e., to benefit all of humanity.
Therefore, GCP guidelines include details, such as the protection of human rights as a subject in clinical trials. They also provide assurance of the safety and efficacy of the newly developed compounds.
As prescribed by the international standards and requirements, a basic understanding of GCP is pre-requisite for anyone carrying out, or involved with, c. research and c. trials. The training is therefore relevant to:
- Investigators from NHS organizations, university hospitals, pharmaceutical companies, and research institutes
- Research Nurses
- R&D staff involved with approving and monitoring trials
- Members of ethics committees
- CRO staff
PharmaLessons has recently launched a new up-to-date GCP online course. The web-based training is completely free for everybody interested in being aware of the newest GCP regulations.
The course has been created to answer the need of people and organizations to have easy access to the ICH GCP guidelines. With the help of the free GCP online course, people will manage to see all important information related to Regulatory Affairs and working process requirements.
The content of the course is divided into several chapters, which cover all the necessary information regarding GCP regulations
Our customer’s comfort is our top priority. This is why we offer maximum flexibility with all of our training solutions.