Statistical Monitoring of Clinical Trials: Fundamentals for Investigators

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Statistical Monitoring of Clinical Trials: Fundamentals for Investigators

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About this book

Bosch, P. Devereaux, R. Collins, C. Baigent, C. Granger, R. When a local investigator is the sponsor, there may not be formal adverse event reports, but study staff at all locations are responsible for informing the coordinating investigator of anything unexpected. The local investigator is responsible for being truthful to the local IRB in all communications relating to the study. Approval by an Institutional Review Board IRB , or ethics board, is necessary before all but the most informal research can begin.

In commercial clinical trials, the study protocol is not approved by an IRB before the sponsor recruits sites to conduct the trial.

However, the study protocol and procedures have been tailored to fit generic IRB submission requirements. In this case, and where there is no independent sponsor, each local site investigator submits the study protocol, the consent s , the data collection forms, and supporting documentation to the local IRB.