A protocol document explicitly states the objectives and reasoning behind a research project. It outlines the structure and design of experiments included in the research. Preparation of a protocol is essential in the research phase and is written for several reasons. These include answering potential questions, planning the project in detail before beginning, giving an overview of the entire process, creating a guide for everyone involved, providing the initial structure and aims for the project and helping monitor the progress.
It is important to include a presentation of the problem in the protocol. In a few words, explain what type of study will take place, include an overview of science supported by literature that will be included in the research, recognize any laboratory testing and report technical data. Furthermore, identify the variables being tested, the population subject to be studied and the rationale for the study. The reader should know in detail what the research entails and the protocol should answer every question upfront. This is where the hypothesis should be mentioned.
It is important to outline the problem being investigated and research in detail in the protocol. Identify the research problem, use relevant literature to explore the problem's background, and include the method of investigation. Outline the investigation in terms of sample size calculations and statistical methods. Also, include a dissemination of the results expected and potential results.
Although it is important to write down all the practical information, such as the problem investigated and the methods used to find the answers, it is also significant to be critical of the experimental designs and methods used. The protocol should recognize any problems that may be encountered throughout the process, what resources may be needed in addition to the ones already chosen, and planning procedures. Procedures that should be observed through a critical lens include screening periods, tests, studies, schedules and questionnaires, if applicable.
Make sure to include an appendix at the end of the protocol, as the report can end up being quite long with several references. Include information such as procedures that are not specifically outlined in the protocol, schedules for activities pertaining to the research, and laboratory values and results, if applicable.