Register Your Clinic or Department in the Czech Clinical Research InstituteĀ“s database

Sign-up for further cooperation

  • Be visible for potential Sponsors (Pharmaceutical & Medical Device Companies)
  • Be part of the European Clinical Research Professionals Network

Good Clinical Practice / GCP Training

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects.

Compliance with this standard provides public assurance that:

  • The rights, safety and wellbeing of trial subjects are protected
  • The clinical trial data are credible
  • The protection of clinical trial subjects is consistent with the principles set out in the Declaration of Helsinki - this is a statement of ethical principles developed by the World Medical Association

Requirements for the conduct of clinical trials in the European Union (EU), including GCP and Good Manufacturing Practice (GMP) and GCP or GMP inspections, are implemented in:

  • The 'Clinical Trial Directive' (Directive 2001/20/EC)
  • The 'GCP Directive' (Directive 2005/28/EC)

Information concerning the activities in EU member states can be found via the Heads of Medicines Agencies.

GCP and Clinical Trial Conduct Training

  • Good Clinical Practice (GCP) principles
  • The role of a clinical research investigator in clinical research
  • Regulatory requirements for clinical research
  • Clinical research methodology and its role in pharmaceutical development
  • Preparation for site audit
  • Clinical trial documentation management

EU Harmonization

The European Medicines Agency plays an important role in the harmonization and co-ordination of GCP-related activity at an EU level. It is involved in:

  • Coordinating GCP inspections for centralized procedures
  • Preparing guidance on GCP topics through the work of the GCP Inspectors Working Group
  • Coordinating advice on the interpretation of EU GCP requirements and related technical issues
  • Developing of EU-wide guidelines on GCP inspections and related procedures for centralized procedures

International Clinical Trials

Regardless of where they are conducted, all clinical trials included in applications for marketing authorization in the EEA must be in accordance with:

  • The GCP Directive (Directive 2001/83/EC Annex I, as amended by Directive 2003/63/EC)
  • The ethical standards of the Clinical Trials Directive (Directive 2001/20/EC)

In July 1996, the EU adopted the guideline for Good Clinical Practice, which lays out unified GCP standards for Europe, the United States of America and Japan.

Regulatory Requirements

Timelines

timeline

Clinical Trials Database

Database of publicly and privately supported recruiting clinical studies of human participants in the Czech Republic (service of the U.S. National Institutes of Health):

Clinical Trials Database reports | ClinicalTrials.gov