Good clinical practice (GCP) is an international quality standard that governments may subsequently translate into legislation for human subjects clinical studies. GCP adheres to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and imposes stringent restrictions on clinical research ethics.
High standards are necessary for complete clinical protocol documentation, record keeping, training, and facilities, including computers and software. Inspections and quality assurance verify that these criteria are met. GCP is intended to guarantee that studies are scientifically valid and that the clinical features of the investigational product are appropriately recorded.
GCP rules include human rights protection for clinical trial participants and volunteers. It also guarantees the safety and effectiveness of newly discovered chemicals. GCP guidelines specify the duties and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors, as well as the criteria for how clinical trials should be performed. Monitors are sometimes referred to as clinical research associates in the pharmaceutical sector.
A succession of failed and ineffective clinical studies in the past prompted the development of ICH and GCP standards in the United States and Europe. These debates eventually resulted in the creation of specific norms and principles, which developed into the code of practice for worldwide uniformity in quality research.
Status in terms of law and regulation
- The European Union: Good Clinical Practice (Directive 2001/20/EC) is supported and controlled in the EU by official law included in the Clinical Trial Directive (Officially Directive 2001/20/EC). The international standard ISO 14155, which is applicable in the European Union as a harmonized standard, provides a comparable guideline for clinical trials of medical devices. To distinguish between the two and the lowest grade of recommendation in clinical recommendations, these clinical trial criteria are frequently referred to as ICH-GCP or ISO-GCP.
- The United States: Although the Food and Drug Administration (FDA) recommends ICH GCP criteria, they are not mandatory in the United States. The National Institutes of Health mandates Good Clinical Practice training all NIH-funded clinical investigators and clinical trial personnel participating in the design, conduct, monitoring, or administration of clinical trials.
Overview of ICH GCPs
ICH GCP Guidelines Glossary Principles for: institutional review board (IRB) / independent ethics committee (IEC) investigator trial sponsor (industrial, academic) clinical trial protocol and protocol changes
investigator’s pamphlet
necessary papers
Criticism
The GCP has been described as “a less morally authoritative document” than the Helsinki Declaration, lacking moral principles and advice in the following areas:
- Conflict of interest disclosure
- The study’s design has been made public.
- Benefit to populations where research is being undertaken
- Accurate results reporting and dissemination of unfavorable findings
- Treatment once research has been completed
Placebo usage is restricted in the control group when an effective alternative therapy is available.
Ben Goldacre addresses these critiques in his book Bad Pharma, noting that the GCP guidelines “aren’t terrible… [they are] more focused on procedures, whereas Helsinki clearly articulates moral principles.”
