3. Key GxPs in Medicine

GCP is an international ethical and scientific quality standard defined by the ICH for the design, oversight, recording and reporting trials for the products that involve testing in humans. The standard outlines the requirements of a clinical trial and the roles and responsibilities of the involved people and their function. It ensures that no human experiments are performed just for the sake of medical advancement.

Compliance with this standard laid out by the ICH and other guidelines should achieve:

• Protection of participants in clinical trials. Ensure that rights, safety and well-being of trial participants are protected, consistent with the principles of the Declaration of Helsinki.
• Confidentiality of records that could identify participants. Respecting privacy and confidentiality rules in accordance with the applicable legislative requirement(s)
• Quality and integrity of the data collected. Ensure that the clinical trial data are credible.

The principles of the ICH GCP guideline as the core document are listed below:

• Before a clinical trial is initiated, the possible risks must be considered against the expected benefits. The trial must only go ahead if the expected benefits outweigh the foreseeable risks.
• The trial must be based on sound scientific knowledge and its procedures must have been approved by the relevant regulatory authority and must have obtained a positive opinion by a review board or ethics committee before the trial proceeds.
• A trial should be conducted in compliance with a clear, detailed protocol
• All personnel involved in conducting a trial should have the proper education, training, and experience to perform his or her role.
• All trial participants must have given consent freely and based on full information about what they're consenting to.
• Any medical care provided must be given by a qualified medical professional.
• All data should be recorded, handled, and stored in a way that allows it to be accurately reported, interpreted, and verified, irrespective of the type of media used.
• Any records in which trial participants could be identified should be kept confidential.
• Investigational products should be adequate to support the proposed clinical trial based on available non-clinical and clinical information and should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

These principles are further elaborated and cover topics such as the roles and responsibilities of the Institutional Review Board / Independent Ethics Committee (IRB/IEC), the investigator, the sponsor; resources, trial protocol, trial management and compliance with protocol, data handling and record keeping, safety reporting, informed consent and medical care of trial participants, quality management, manufacturing, packaging, labelling, and coding investigational product(s), monitoring, auditions, the investigator’s brochure (a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in humans. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with many key features of the protocol)

Legal basis:
Directive 2005/28/EC), the 'GCP Directive'

ICH E6 (R2) ‘Guideline for Good clinical practice’; adopted by the EU in 1996, which provides a unified standard for the ICH regions (European Union, Japan, the United States, Canada, and Switzerland) to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.

Directive 2001/20/EC, the 'Clinical Trial Directive'
When the Regulation (see below) becomes applicable on 31 January 2022, it will repeal the Clinical Trials Directive (EC) No. 2001/20/EC and national legislation that was put in place to implement the Directive

Regulation (EU) No 536/2014, the 'Clinical Trial Regulation’; becomes applicable on 31 January 2022

Specific Guidelines have been developed for ATMPs (October 2019).
Guidelines on Good Clinical Practice (GCP) specific for Advanced Therapy Medicinal Products (ATMP)

For more details in view of the EMA on GCP see:
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical-practice

For more information on clinical trial authorisation, safety monitoring, GCP inspections, and GCP and GMP requirements for clinical trials in the European Economic Area (EEA), see EudraLex - Volume 10 - Clinical trials guidelines.