Good Clinical Practice (GCP)

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.

GCP follows the International Conference on Harmonization (ICH) of GCP guidelines. GCP enforces tight guidelines on ethical aspects of a clinical study. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview or survey, GCP provides investigators and their study teams with the tools to protect human subjects and collect quality data. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.

GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates.

Why should you Attend: In 1997, the Food and Drug Administration (FDA) endorsed the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonization (ICH). GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. As prescribed by the international standards and requirements, a basic understanding of Good Clinical Practice is prerequisite for anyone carrying out, or involved in, clinical research and clinical trials.

The course is therefore relevant to Investigators from hospitals, pharmaceutical companies, and research institutes, Clinical trials support staff (e.g staff working in contract research organizations), R&D staff involved in approving and monitoring clinical trials, Members of Institutional Review Boards, Graduates looking to develop a career in clinical research.

Areas Covered in the Session:

• Good Clinical Practice standards
• Compliance with FDA and ICH regulations

• Principal Investigators
• Clinical Research Scientists
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting Staff
• QA / QC auditors and Staff
• Clinical Research Data Managers