Good clinical practice

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Good clinical practice (abbreviated GCP from English good clinical practice ) describes internationally recognized rules for conducting clinical studies based on ethical and scientific criteria . The focus is on the protection of study participants and their informed consent, as well as the quality of the study results. GCP is part of the GxP guidelines for "good working practice" in the development and manufacture of pharmaceuticals .

History and legal status

The first country with formal GCP rules was the USA ( FDA -GCP) in 1977 . The first GCP rules were published in the European Community in 1989 (EU-GCP Note for Guidance). In 1991, the principle of good clinical practice was prescribed in the European Union by EC Directive 91/507 / EEC, but not defined in detail. In the course of the harmonization between the USA, Europe and Japan within the framework of the ICH , the detailed ICH-GCP guideline E6 was completed in 1996 and adopted by the EMA's Committee for Medicinal Products for Human Use (CHMP) as a European guideline. A large number of individual regulations, including a Europe-wide uniform authorization requirement for clinical studies, were stipulated by Directive 2001/20 / EC on the application of good clinical practice (GCP Directive), followed by Directive 2005/28 / EC on principles and guidelines the Commission's good clinical practice . Directive 2001/20 / EC was implemented in Germany in 2004 by the twelfth amendment to the Medicines Act and by the GCP regulation in binding national law. This means that GCP is much more than just a guideline .

However, since not all EU member states (e.g. Austria) have integrated ICH-GCP into their national laws, the EU Parliament passed Regulation (EU) No. 536/2014 on clinical trials on April 16, 2014 Medicinal products for human use and repealing Directive 2001/20 / EC. With the start of application (`` due to BREXIT probably not until 2025 '') of the regulation, the EU obliges all member states to comply with GCP without direct implementation in national law.

On December 15, 2016, the Committee for Human Medicinal Products (CHMP) released a new revision (R2) of the Guideline for good clinical practice for the first time since 1997. On June 14, 2017, this finally came into effect. The revision was due to necessary adjustments based on the increasing complexity and costs of clinical studies, as well as the development in technology and risk management processes. Advances in the use of electronic data collection and reporting needed to be taken into account.

For medical devices , the work of the Global Harmonization Task Force was followed by references in the European Medical Device Directive and, since 2010, in the German Medical Devices Act (MPG) to the European harmonized standards, among others. a. EN ISO 14155. The revised version of which has been translated into German bears the title “ DIN EN ISO 14155: 2012-01: Clinical testing of medical devices on humans - Good clinical practice ( ISO 14155: 2011 + Cor. 1: 2011); German version EN ISO 14155: 2011 + AC: 2011 ". Due to the regulations (EU) No. 745/2017 for medical devices and No. 746/2017 for in-vitro diagnostics, the requirements for quality standards in medical device studies and performance evaluation tests have also increased, which is why the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) initiated a revision of DIN EN ISO 14155: 2018. However, this is currently only available as a draft version and is not yet valid. Based on the revision (R2) of ICH-GCP, the revision of DIN EN ISO 14155: 2018 essentially includes a significant strengthening of risk management in the entire process of a clinical trial (from planning to consideration of the results).

In the case of medical device studies and performance evaluation tests of in-vitro diagnostics, however, compliance with DIN EN ISO 14155 was not legally mandatory in the EU until now. With the start of application of Regulations (EU) No. 745/2017 for medical devices on May 26, 2020 and Regulation (EU) No. 746/2017 for in-vitro diagnostics on May 26, 2022, ISO 14155 will apply to all EU member states legally binding.

These quality standards are also abbreviated to ICH-GCP or ISO-GCP in order to differentiate between them and to differentiate them from the lowest level of recommendation in clinical guidelines.

Content of the GCP rules

The GCP guidelines and guidelines define in detail the roles that the various parties involved play in a clinical trial:

  • A sponsor (usually a pharmaceutical company ) finances the study, makes the investigational drug available, commissions the investigator and provides insurance cover (test subject insurance). The sponsor has primary responsibility for the quality of the study data.
  • The examiner and the testing facility (often a clinic) must meet certain qualification requirements.
  • A CRO (Contract Research Organization, CRO) can take over some tasks of the sponsor in the implementation.
  • The ethics committee monitors the qualifications of the examiners and the study plan .

In addition, central documents for the implementation of clinical studies such as the study plan, investigator information and standard operating procedures are defined. In order to protect the study participants, it is determined how the consent is to be given and how to proceed in the event of unexpected side effects , especially serious adverse events . GCP sets out in detail which quality management processes are to be introduced (see below). The requirements of the European GCP guidelines go beyond ICH-GCP in some aspects, for example the requirement that all investigational medicinal products must be manufactured in accordance with GMP .

Quality management

A quality management is a core component of GCP. Ongoing quality control is carried out by monitors who monitor an ongoing study on behalf of the sponsor. Among other things, it ensures that the data entered in the Case Report Form match the source documents in the clinic. Furthermore, the sponsor is obliged to carry out random audits for quality assurance purposes , during which the quality of the study implementation and the study data is checked. Finally, there is monitoring of investigators, trial centers and sponsors through inspections of national drug authorities . In particular, during the examination of drug approval applications, the data presented there is checked by on-site inspections.

Web links

Individual evidence

  1. INTERNATIONAL COUNCIL FOR HARMONIZATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH): Guideline for Good Clinical Practice E6 (R2). Retrieved March 13, 2019 .
  2. BfArM, The test plan according to ISO 14155 requirements, implementation and subsequent changes ( Memento of November 4, 2013 in the Internet Archive ).
  3. International Organization for Standardization (ISO): DIN EN ISO 14155: 2018-08 - draft. In: www.beuth.de. European Committee for Standardization (CEN), June 29, 2018, accessed on March 13, 2019 .
  4. Examples of guidelines that use “Good Clinical Practice” as the lowest level of recommendation  ( page no longer available , search in web archivesInfo: The link was automatically marked as defective. Please check the link according to the instructions and then remove this notice. .@1@ 2Template: Dead Link / www.guideline.gov