Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
Hamilton Cosmetics Laboratory works according to Good Clinical Practice (GCP) standards, which means that:
- Clinical trials are conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
- Before a trial is initiated, foreseeable risks and inconveniences will be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and will prevail over interests of science and society.
- The available nonclinical and clinical information on an investigational product will be adequate to support the proposed clinical trial.
- Clinical trials will be scientifically sound, and described in a clear, detailed protocol.
- A trial will be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects will be always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial will be qualified by education, training, and experience to perform his or her respective task(s).
- Freely given informed consent will be obtained from every subject prior to clinical trial participation.
- All clinical trial information will be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
- The confidentiality of records that could identify subjects will be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
- Investigational products will be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of the trial will be implemented.
During the study, we carry out a GCP compliant document (Case Report Form, Constant Form, Adverse Events etc). Ours Project Managers and their assistants in constant contact with the Sponsors.