Good Clinical Practice
The English term Good Clinical Practice ( GCP) ( German: " Good Clinical Practice " ) refers to internationally recognized, prepared in accordance with ethical and scientific points of rules for the conduct of clinical trials. Here are the protection of study participants and their informed consent and the quality of the study results at the center. GCP is part of GxP guidelines called for " good work practice " in the development and manufacture of pharmaceuticals.
History and Legal Status
The first country with formal GCP rules were 1977, the United States ( FDA GCP). In the European Community first GCP rules were published in 1989 (EU -GCP Note for Guidance ). In 1991, the principle of good clinical practice by the EC Directive 91/507/EEC was prescribed in the European Union, but not defined in detail. As part of the harmonization between the U.S., Europe and Japan in ICH detailed ICH GCP Guideline E6 completed in 1996 and approved by the Committee for Human Medicinal Products ( CHMP) of the EMEA as a European guideline. A variety of specific regulation, including a Europe-wide authorization for clinical studies were required by Directive 2001/20/EC on the implementation of good clinical practice ( GCP Directive), Directive 2005/28/EC by on principles and guidelines of good clinical practice, the Commission has been added. Directive 2001/20/EC was implemented in Germany in 2004 by the Twelfth Amendment Act on Drugs Act and by the GCP into binding national law. This GCP is far more than just an advisory guideline.
For medical devices followed the work of the Global Harmonization Task Force references in the European Medical Device Directive and since 2010 in the German Medical Devices Act ( MPG) on the European harmonized standards, including. EN ISO 14155 Their revised and translated into German, transmitted version bears the title "DIN EN ISO 14155:2012-01: Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 Cor 1:2011. ); German version EN ISO 14155:2011 AC: 2011 ".
These quality standards are also ICH- GCP and ISO -GCP abbreviated to distinguish between them and to distinguish them from the lowest grade of recommendation in clinical guidelines.
Content of the GCP rules
In the GCP guidelines and policies defined in detail, play what roles the various participants in a clinical trial:
- A sponsor (usually a pharmaceutical company ) funded the study, presents the test product available, instructed the investigators and provides insurance protection ( insurance subjects ). The Sponsor has the primary responsibility for the quality of the study data.
- The auditor and the auditor ( often a hospital ) must meet certain qualification requirements.
- A CRO (Contract Research Organization, CRO) can take over some tasks of the sponsor in the conduct.
- The Ethics Committee monitors the qualifications of the investigators and the study plan.
In addition, key documents for the conduct of clinical trials such as protocol, investigator's brochure and Standard Operating Procedures are defined. To protect the study participants is established, as the consent is to be made, and as in the case of unexpected side effects, particularly serious adverse events to proceed. In GCP is set forth in detail the quality management processes are to be introduced ( see below). The requirements of the European GCP guidelines go into some aspects about ICH GCP addition, as for example in the requirement that all investigational medicinal products must in principle be manufactured according to GMP.
A quality management is a core part of GCP. The current quality control is carried out by monitors that monitor an ongoing study on behalf of the sponsor. This ensures, among other things, that the data entered in Case Report Form data with the source documents in the clinic match. Furthermore, the sponsor is required to conduct random audits for quality assurance, where the quality of the study conduct and study data is checked. Finally, monitoring of investigators, study sites and sponsors out inspections of national drug regulatory authorities takes place. In particular, during the examination of drug approval applications, the data presented here are verified by on-site inspection.