The hypothesis must be understood as an attempt to predict or propose a relationship between two or more variables. It should only be formulated after an understanding of the subject, review the bibliography and consider all the factors that may intervene in the development of the project, including -in a fundamental way- the material and equipment possibilities for its development. It can not be a mere disordered or chaotic, irregular conjecture, but reflect the knowledge, imagination and experience of the researcher. It can be said that the objectives arise from the question, the hypothesis arises from the main objective (is its explanatory approach); and, in addition, that the main variable is defined in the main objective.
Within the methodology of the study we will describe the tactics used to achieve the objectives and establish controls on the situation being investigated. It represents the main nucleus of the research project; is what will allow us to accept that any conclusion has some value and can be accepted as scientific knowledge. It has been said very synthetically that the methodology is “the why of the how” of an investigation. It is not, therefore, a list of techniques and you will have to explain step by step how you expect to “produce” the data required to answer the research question. Your summary of the methodological approach should be done in about 150-500 words. When presenting the study subjects, we will have to detail the presence of inclusion / exclusion criteria, the size of the sample and the sampling design. In your case, the existence of comparison group, type of controls and existence of procedures of assignment to each group. The methodological reference of the PI must describe in a precise and documented way the variables (main and secondary) that will be analyzed, establishing its definition and the way to measure them. In fact, as has been pointed out, knowledge of the different variables of a project will help to outline its objectives. As for the collection of data, the researcher will describe the procedure followed, its organization and coding. The method for data collection may consist of questionnaires, interviews, medical examinations, laboratory studies or screening procedures, which must be described in their contents as well as in their execution (delivery, collection, type of questions, citation, etc.). It will specify the control of possible errors and biases, and of the mechanisms to guarantee the quality of the measurements. When referring to the analysis of the data, a reasoned description of the organization plan and synthesis of the information obtained will be made, which will allow us to improve the interpretation of the observations and make deductions about the reliability of the same. The statistical tests applied and any program or software package used in the elaboration of the data must be cited.
Regarding the applicability and practical utility of the results, it should indicate the relevance of the research and the magnitude of its sanitary utility (its future applicability), expressed in a realistic and simple way. For any step that can not be resolved by the Principal Investigator, it must be demonstrated and justified before the correctors that another component of the team is qualified to solve it. This is done by declaring the experience of the research team (which will support its credibility), mainly related to the topic to be investigated; and it would consist of 2 to 5 sentences for each researcher picking up their previous lines of work. In the section of available means to carry out the project we have to detail the human and material resources for which you do not need to ask for help (height meters, tensiometers, offices or consultations, computers, personnel of the center or other people who will not be part of the team …) indicating its origin, location and property.
In the action plan, the list of activities necessary to achieve the objective of the study and its organization of human and material resources around the project will be advanced. The PI can be accompanied by a schedule of activities that will present ordered – in a table or table – in time – in days, weeks or months – the most relevant processes for the development of the research.
It must be clear that the research complies with all the ethical requirements that may be required by the type of study that we are going to carry out, indicating the official bodies or institutions responsible for its supervision. The ethical approval must be issued by the ethics committee that corresponds to the institution, must assess the project and express its authorization. This will be required in all studies with humans, and especially with children. We must attach the issued certificate and add it as an annex to the PI.
The budget must account for the costs of the research, broken down into sections and chapters, preferably presented through a table. In the column on the left, the different sections are listed, indicating for each one the expenditure chapters: personnel (interns, administrative staff, services with cost, other types of contracts), inventory material (infrastructure, measurement and registration devices, computers , etc.), consumables (stationery, computer media, test tubes, reagents, etc.), travel and subsistence allowances (trips to carry out field work, attendance at conferences, work meetings, etc.), and others. In the middle column, the budgeted expense for each chapter. And on the right the total of each section. Logically in the lower right corner will be located the total sum of the different sections, which will be the estimated amount of aid requested for the development of the investigation. The request must be reasonable, balanced and adjusted to the maximum amount established if it exists.