It covers areas that include:
- making the care of patients the first concern
- providing a good standard of practice and care, and working within competence
- working in partnership with patients and supporting them to make informed decisions about their care
- treating colleagues with respect and help to create an environment that is compassionate, supportive and fair
- acting with honesty and integrity and being open if things go wrong
- protecting and promoting the health of patients and the public
This guidance came into effect on 30 January 2024.
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.
GCP guidelines[1] include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research
Nursing Practice (NP)
Nursing practice involves advocacy for the rights of the individual patient and for their family. It also involves advocacy on behalf of nursing practice in organisational and management structures within nursing.
