Certifications In Clinical Research

Clinical Research is the research done at clinical level; experimentation on human

volunteers to answer specific questions related to biomedical interventions. ICH-GCP defines clinical trial as, Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous, 1.12, E6 Guideline for Good Clinical Practice.

Clinical research industry has opened a wide range of opportunities for clinical research professionals. As principles of GCP states that Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s), anyone who is involved either directly or indirectly in clinical trial conduct, must be qualified accordingly. A certification in clinical research would give an additional potency to the candidate who is aspiring a career in clinical research industry.

To enter clinical research industry, basic knowledge in clinical research is sufficient but to climb the hierarchy ladder, continuing education is must. There are many organizations and societies which provide such continuing education by providing training and certification to the professionals. One such organization is Clinical Research Society.

Clinical Research Society offers the most robust certification programs in the clinical research industry. Clinical Research Society provides a platform to all clinical research professionals to share and update their knowledge. Clinical Research Society offers multiple training and certification programs which are designed to meet the training needs of the clinical research enterprise. Those include:

Certified Clinical Research Associate

Certified Clinical Research Coordinator

Certified Clinical Project Manager

Good Clinical Practice (GCP) Certification

All these programs are available for clinical research society members and non-members. CRS membership avails extra benefits in addition to the certification programs. These programs are offered through state-of-an-art learning management system where multimedia presentations, case scenarios and other course related material can be accessed online at the members own pace.

Certification programs consist of a thorough online training followed by proctored certification exams conducted online using advanced screen sharing technologies, webcams and microphones. Post the online training sessions, candidates are evaluated for their knowledge in niche areas of clinical research and other resources that may include the FDA website, international and/or local policies, regulations, and guidelines, best practices, etc.

by: Sai Kumar Krishna

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