Abstract
The clinical research protocol is the document in which the investigator expresses in advance the research problem that he or she is interested in. This document must be written with great care, since it reflects the comprehension that the investigator has of the state of the art and the place of his particular problem in the proposed area of research. When the investigator writes the protocol, he organizes his thoughts about the research problem: how clear is the question?, are the methods consistent with the objectives?, how is the answer to be handled?. Through the protocol, the investigator can realize if the project can be done and if he or she has the time and the money to carry it out. A wealth of information about how to write scientific articles have been published (1–7). However, a short and comprehensive review about how to plan the various kinds of clinical investigations is non existent. The present article is an attempt to describe the necessary guidelines to organize the clinical research protocol; provides information to understand the methodological structure of the original research articles found in modern medical publications, and offers references to the pertinent literature.
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Cañedo, L.E., Elizondo, G. (1988). Planning the Clinical Research Protocol to Understand the Relationship Between Cell Function and Disease. In: Cañedo, L.E., Todd, L.E., Packer, L., Jaz, J. (eds) Cell Function and Disease. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-0813-3_42
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