GoodClinicalPracticeGCP-KennesawStateUniversity.pptVIP

By: Kris Traver and Nitin Jain Goals and Objectives To understand: The affect of Good Clinical Practices on institutions conducting Clinical Research To discuss: What is GCP Guidelines for GCP The history of Good Clinical Practices Basic principles Practices and strategy for staying compliant with Good Clinical Practices. What Is GCP? Good Clinical Practice (GCP) is defined as a ‘standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected’ Good Clinical Practice Guidelines Are mainly focused on the protection of human rights in clinical trial. Provide assurance of the safety of the newly developed compounds. Provide standards on how clinical trials should be conducted. Define the roles and responsibilities of clinical sponsors, clinical research investigators, Clinical Research Associates, and monitors. Good Clinical Practice Guidelines (Continued) GCPs are generally accepted, international best practices for conducting clinical trials and device studies They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible The Core of the Consolidated GCP Guidance 1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements 2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial