Clinical trial conduct/execution

The clinical trial should be conducted methodically with clear objectives and outcomes that are statistically verifiable. The precUnical and toxicological data should have been carefully analyzed and should confirm the scientific finding. The trial should not be biased and should be able to be executed without unreasonable caveats and conditions. 

Japanese GCP requires that the head of the medical institute and the sponsor must execute a study contract, and does not allow the investigator to directly contract with the sponsor. Historically, a clinical trial is considered as an activity of the hospital as a whole, not of an individual investigator. The reason behind this is that the investigator cannot conduct any study without the full support of hospital staff and access to hospital facilities. The head of the medical institute is responsible for organising an IRB in-house or to make it available outside the hospital, if the hospital is not large enough to maintain an IRB. Once the sponsoring company submits the clinical study plan to the hospital, the head of the medical institute should submit the study document to the IRB for their opinion. The head cannot be a member of the IRB, is not allowed to discuss or vote on the clinical trial, but nevertheless attendance to the IRB is not prohibited. 

When the clinical research team has decided on their research question, and the appropriate study design and methodology to acquire optimum quality data with which to answer this question, all this information needs to be documented. The clinical study protocol is the document that is written for this purpose. Chow and Chang (2007, p 1) noted that the study protocol is "the most important document in clinical trials, since it ensures the quality and integrity of the clinical investigation in terms of its planning, execution, conduct, and the analysis of the data."... 

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