Good Clinical Practices

The International Conference on Harmonization's (ICH) Good Clinical Practice (GCP) guideline,is an international ethics and scientific standard for the design, conduct, recording, and reporting of clinical trials that involve human beings. It is also applicable to other clinical research that may affect human safety and wellbeing.

It aims to provide one single regulation for the European Union, Japan and the United States, thus making it easier for the regulatory authorities of each of these jurisdictions to mutually accept clinical data.

Compliance with this regulation provides a public guarantee of the protection of rights, safety and wellbeing of trial patients according to the principles of the Declaration of Helsinki and ensures the credibility of clinical trial data.

The principles of the guideline are as follows:

• Clinical trials must be conducted according to the ethics principles derived from the Declaration of Helsinki and consistently with GCP guidelines and the applicable legislation.
• Before starting a trial, any foreseeable risks and inconveniences must be considered with respect to the expected benefits, both for each patient of the trial and for society in general. Trials must be started and continued only if the expected benefits justify the risks.
• The rights, safety and wellbeing of the patients of a trial are the most important considerations and must prevail over the interests of science and society.
• Clinical and non-clinical information available about an investigational drug must be enough to support the clinical trial proposed.
• Clinical trials must be scientifically justified and described in a clear and detailed protocol.
• Trials must be conducted according to a protocol with a prior favorable opinion by a Clinical Research Ethics Committee (CREC).
• Medical care provided to patients and medical decisions made on their behalf will always be the responsibility of a qualified physician or, if applicable, a qualified dentist.
• Every person involved in conducting a trial must be qualified to carry out his/her duties and respective responsibilities based on his/her degree, training and experience.
• An informed consent must be voluntarily obtained from every patient before joining a clinical trial.
• All the information regarding the clinical trial must be recorded, handled and filed in such a way that it allows its communication, interpretation and accurate verification.
• The confidentiality of records that may identify patients must be protected by complying with privacy and confidentiality policies based on applicable legislation requirements.
• Investigational drugs must be manufactured, handled and stored according to applicable Good Manufacturing Practices (NCF) and must be used based on the approved protocol.
• Procedure systems ensuring the quality of each aspect of the trial will be implemented.

GCP guidelines must be followed when generating clinical trial data that must be filed with the regulatory authorities. In Spain, they must be submitted to the Spanish Agency of Medicinal Products and Medical Devices