GCP stands for Good Clinical Practices in clinical research and came into existence as a response to the violations of historical ethical principles in research, such as the Nuremberg Trials and the Tuskegee Syphilis Study. These historical events highlighted the urgent need for formalised protections for human subjects or clinical study participants. The ethical foundation was laid by the Declaration of Helsinki (1964), and later, the International Council for Harmonisation (ICH) developed the ICH-GCP E6 guideline, which has since become the global benchmark. Regulatory bodies like the U.S. FDA, EMA, and CDSCO in India mandate GCP compliance for clinical trials intended to support drug approval.
Good clinical practices play the role of a rule book that mentions the precise way to conduct clinical research. It ensures the safety of human participants in the clinical trials. Researchers have to abide by the rules mentioned in GCP about how to conduct studies and report their findings. This helps to ensure the safety and effectiveness of the medicines or treatment therapies before they are used on many people. It helps to ensure that the rights, safety, and well-being of participants are protected, and that the data generated is reliable and credible and accurate.
- Ethical Conduct: It is mandatory to conduct clinical trials in accordance with the ethical principles that originated from the Declaration of Helsinki.
- Risk vs. Benefit: The anticipated benefits of the trial should justify the foreseeable risks and inconveniences to the participants. The benefit-to-risk ratio should outweigh the risk factors.
- Rights, Safety, and Well-being: The rights, safety, and well-being of trial participants are the most important considerations and should prevail over the interests of science and society.
- Adequate Preclinical & Clinical Information: Clinical trials should be initiated and continued only if the available nonclinical and clinical information provides adequate justification for the proposed trial.
- Scientifically Sound Protocols: Clinical trials should be scientifically sound and described in a clear, detailed protocol that can be understood by the professionals as well as the trial participants.
- Compliance with Protocol & Good Clinical Practices: A trial should be conducted in compliance with the protocol that has received prior approval or a favourable opinion from an Independent Ethics Committee (IEC) / Institutional Review Board (IRB).
- Medical Care by Qualified Professionals: Medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician.
- Qualified Investigators & Qualified Staff: Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective tasks.
- Informed Consent: Freely given informed consent should be obtained from every subject before participation in the clinical trial.
- Trial Data Recording & Handling: All clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification.
- Confidentiality: The confidentiality of records that could identify clinical trial participants should be protected, respecting privacy and confidentiality rules in accordance with applicable laws and regulations.
- Investigational Product (IP) Handling: Investigational products should be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practice (GMP). They should be used in accordance with the approved protocol.
- Quality Systems: Systems with procedures that assure the quality of every aspect of the trial should be implemented.
Good Clinical Practice (GCP) forms the backbone of modern clinical research, ensuring that trials are conducted ethically, safely, and with scientific integrity. The 13 principles act as universal guidelines to protect participants while generating reliable and credible data for new medicines and therapies. By adhering to these standards, researchers, sponsors, and regulatory authorities can work together to safeguard human rights, minimize risks, and advance medical science responsibly. Compliance with GCP is not just a regulatory requirement but a moral obligation to maintain trust in clinical research and ensure better healthcare outcomes for society.
