Good Clinical Practice (gcp) Training & Certification

The principles of GCP state that: Each individual involved in conducting a trial

should be qualified by education, training and experience to perform his or her respective task(s). 2.8, E6 Guideline for Good Clinical Practice. These guidelines were laid to provide a universal platform where a single set of standards were developed and followed. Later on in 1997, this guideline came into effect as guidance by a steering group termed the Tripartite International Conference on Harmonization (ICH) which included regulatory authorities of the EU, Japan and US.

The two important objectives of these guidelines are: safeguarding the rights of human subjects and authenticity of biomedical data generated. Any individual who is directly or indirectly contributes his/her participation in conducting of clinical trial must have the knowledge of good clinical practice (GCP). They should aware of all applicable local and international regulations and guidelines to protect and safeguard the rights of human subjects.

A training and certification on good clinical practice enriches the individual with updated knowledge and proves himself/herself as a certified professional for participating in clinical research conduct. If such training and certification is achieved from a good training provider, it is accepted widely in the clinical research industry; the certification reflects the candidates knowledge and ability to conduct the clinical trial. Most of the Contract Research Organizations, Pharmaceutical and Biotech companies are asking for such certifications while recruiting the emerging professionals in clinical research. GCP certification is necessary for all professionals in clinical operation, data management, quality assurance, regulatory affairs, biostatistics departments etc.

Clinical Research Society, a worldwide society for clinical research, provides such training and certification programs for Good Clinical Practice (GCP). The CRS GCP Certification program is offered through a state-of-the-art learning management system that provides a user friendly platform to access the multimedia presentations, case scenarios and other useful resources at members self-pace. One of the most important features of the GCP Training program is that it is self-paced and can be accessed by the member at any time until the Certification Examination.

The curriculum of GCP Certification has been fully endorsed and developed by clinical research industry professionals with years of experience and extensive knowledge in niche areas of clinical research. The members are tested for their understanding and application of GCP during the certification program not only on the basis of study material provided to them, but also other resources like FDA website, international and/or local policies, regulations, and guidelines, best practices, etc.

by: Sai Kumar Krishna

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