Governments may include good clinical practice (GCP), an international quality standard, into regulations governing clinical trials involving human subjects. GCP conforms to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and supports tight laws on the moral implications of clinical research.
Extensive clinical protocol paperwork, record-keeping, training, and facilities, including computers and software, are all required. These standards are satisfied by inspections and quality control initiatives. GCP aims to ensure the scientific validity of the research as well as the correct reporting of the clinical aspects of the investigational product.
GCP Good Clinical Practice guidelines require the protection of human rights for clinical trial participants and volunteers. Furthermore, it ensures the efficacy and safety of newly developed chemicals. The GCP guidelines explain the obligations and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors, as well as the standards for how clinical trials should be conducted. Clinical research associates are a frequent word for monitors in the pharmaceutical industry.
A number of previous unsuccessful and inefficient clinical trials served as the primary motivation for the establishment of ICH and GCP Good Clinical Practice standards in the United States and Europe. These discussions eventually led to the development of a set of norms and principles that formed the code of conduct for the worldwide consistency of high-quality research.
Legislation and regulations
The United Kingdom: The Clinical Trial Directive (formally Directive 2001/20/EC) is the formal piece of legislation in the European Union that supports and oversees GCP Good Clinical practice (Directive 2001/20/EC). The international standard ISO 14155, which is accepted as a harmonised standard in the European Union, serves as a similar prescription for clinical trials of medical devices. The lowest grade of recommendation in clinical recommendations, these clinical trial standards are usually referred to as ICH-GCP or ISO-GCP to differentiate between the two.
States in America The Food and Drug Administration (FDA) supports the ICH GCP standards, however they are not mandatory in the United States. The National Institutes of Health requires GCP training for clinical investigators and trial personnel who receive NIH money and are involved in the design, execution, monitoring, or administration of clinical trials.
An overview of the ICH GCP
ICH Good Clinical Practise (GCP) Guidelines for Institutional Review Boards (IRB) and Independent Ethics Committees (IEC) Glossary
Sponsor of clinical studies (commercial or academic)
Clinical Trial Protocol and Protocol Modifications brochure for investigator critical records
GCP has been described as “a less morally authoritative document” than the Helsinki Declaration because it lacks moral guidance and norms in the following areas:
- Disclosure of Potential Conflicts of Interest
- Design of a research publication
- Beneficial impacts for the populations investigated precise results unfavourable outcomes must be reported and disseminated
- Therapy is now available as a result of study.
- When a more powerful treatment alternative is available, limiting the use of placebo in the control group.
In response to these criticisms, Ben Goldacre comments in his book Bad Pharma that the GCP laws “aren’t terrible… [they’re] more focused on procedures, whereas Helsinki clearly articulates moral principles.”