Research Methodology and Biostatistics Series III - Medical Research Protocol

Validity and reliability of the results of empirical research depends on the precision with which a study is carried out. A medical research protocol answers what, who, when, why, and how of the study, and provides a backbone on which the study rests all through its execution. Thus, careful consideration should be given to the preparation of a protocol. The frame of a protocol contains (i) a title that is brief but adequate to describe the focus of the study, (ii) the rationale of the study in view of the lacunae in the knowledge, (iii) the objectives and the hypotheses in a measurable format, (iv) the design of the study such as descriptive or analytical, and experimental (e.g., trial) or observational (prospective, retrospective, or cross-sectional), (v) the variables to include and exclude along with their definitions, (vi) the target population to which the results would apply, (vii) the sample size and the sampling strategy, (viii) complete methodology of collecting data such as laboratory, radiology and clinical investigations, (ix) the methods of statistical analysis proposed to be followed, and (x) the anticipated results and their medical utility. It also contains the references and appendices, particularly the case record form. All these are described in the protocol along with complete justification so that any third party, such as the funding agency or the reviewers and examiners, are convinced that the study is worth pursuing.