1.

What Is Protocol Document?

Answer»

A CLINICAL Trial Protocol is a document that describes the objective(s), design, METHODOLOGY, statistical considerations, and organization of a clinical trial.

  • The existence of a clinical trial protocol allows researchers at MULTIPLE locations (in a multi-center trial) to perform the study in exactly the same way, so that their data can be combined as THOUGH They were all working together.
  • The protocol also gives the study administrators (often a CONTRACT research organization) as well as the local researchers a common reference document for the researchers' duties and responsibilities During the trial.

A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.


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