Clinical investigators training

Dr. Kazuo Kimura -Trained as a pediatrician, he was the Acting Chief of the Clinical Investigation Branch... 

EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFIES THE INVESTIGATOR AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS ATTACHED. 

The Medical Information department may have its own medical writers dedicated to phase IV (postapproval) publications, booklets and pamphlets. Many large companies have a specific Medical Writing department usually reporting into the Research department, who will assist in writing clinical reports, publications and help prepare the clinical investigational brochure or NDA annual safety reports. These associates usually have science degrees and have been trained in technical and medical writing. 

This is one of the new paradigm shifts in the clinical research arena. Sponsor companies are now being held responsible by regulatory authorities for investigator training in GCP obligations and the ethical conduct of clinical trials. 

An inveshgator must be qualified by educahon, training, and experience to assume responsibility for the proper conduct of a clinical trial and should meet all qualifications specified by the applicable regulatory requirements. Investigators must agree to abide by the decisions of their selected IRB and should comply with all governing rules and regulations. 

The former requirement of categorised result of efficacy, called FGIR or utility and global utility rate (GUR) are not required anymore. For confirmation studies, a single objective, clinically meaningful endpoint should be identified. Where an objective endpoint is not available, subjective endpoints can be used instead. If the endpoint is not well established or subjective, it must be validated. Study investigators or others who are involved in evaluation should be well trained, and their variation of evaluation results should be within an acceptable range. 

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