A research protocol is a document that describes the planning of your study. This plan should be designed to answer the research question and should also provide a detailed description of the objectives, design, methodology and statistics used. The protocol is, in effect, the recipe book for conducting the study.
The first drafting of the protocol of a new research project must start from a solid idea with one or more of these objectives:
Overcoming the limits of current knowledge in a given field in order to fill a “knowledge gap”
Bringing something new in a scantily explored field
Validate or override previous results obtained in limited registries through studies in a larger population.
Main Sections and Subsections of a Complete Research Protocol
Presentation of the Research Protocol
Number of centres involved (for multicentre studies)
Indicate the reference centre
Title of the study
Up to 7 specific keywords
Justification of the Study
Describe current scientific evidence supporting the research with a possible subsection for references
Open/simply blind or double-blind
Parallel branches and overlapping branches
Endpoints (primary and secondary endpoints should be listed)
Main variables/endpoints of the primary analysis
Main variables/endpoints of the secondary analysis
Quality of life (if applicable)
Health economics (if applicable)
Brief description of the main inclusion and exclusion criteria
Estimation of the duration of the study
Better supposed perspective
About the main concept of the study
Description of the main centre, contacts of the researcher(s), quantification of the centres involved
A research protocol must start from the definition of the coordinator of the entire study: all the data of the principal investigator must appear in the first paragraph. This will allow each participant to know who to turn to in case of doubts or criticism during the research. If the study is going to be multicenter, in the first section the number of centers involved must also be written, each possibly paired with the corresponding reference researcher.
Like the abstract of a research paper, the project abstract should be no longer than 300 words and a maximum of one page (font size 12, single line spacing). It will preferably be presented on a separate page, and should summarise all the core elements of the protocol, e.g. justification, objectives, methods, populations, timetable and expected results. It should be independent and not refer the reader to the points of the project description.
Protocol title, protocol identification number (if any), and date.
Name and address of the sponsor/funder.
Name and title of the researcher(s) responsible for conducting the research, as well as the address and telephone number(s) of the research centre(s), including the responsibilities of each.
Clinical laboratory(s) and other medical and/or technical department(s) and/or institution(s) involved in the research (if applicable).
Justification and Background
The justification specifies the reasons for carrying out the research in the light of current knowledge. It should include a well-documented statement of the need/problem that is the basis of the project, the cause of this problem and its possible solutions. It is the equivalent of the introduction of a research paper and places the proposal in its context.
Finally, it must answer the question of why and for what: why the research should be done and what its relevance will be. The magnitude, frequency, geographical areas affected, ethnic and gender considerations, etc. of the problem should be followed by a brief description of the most relevant studies published on the subject.
References (from the literature cited in the previous sections)
References can also be listed at the end of the first part.
Goals and Objectives of the Study
The goals are broad statements of what the proposal hopes to achieve. They create a framework for the proposal. Specific objectives are statements of the research question(s). Objectives should be simple (not complex), specific (not vague) and stated in advance (not after the research has been conducted). After the declaration of the main objective, the secondary objectives can be mentioned.
Second Section: Specific Characteristics of the Research Study
Once the administrative data is completed, the next step is to provide and expand the title of the study: It is done to identify the field of research and the objective of the study itself in a kind of brief summary of the research; the title should be followed by a unique acronym, such as an identification of the protocol. If the protocol has already been exposed and approved by the Ethics Committee, it is advisable to also include the protocol number.
A list of 3 to 7 keywords should be listed to simplify protocol placement in your field of research, including, for example, disease, research tools, and parameters analyzed (e.g., three-dimensional echocardiography, right ventricle, end-stage heart failure, and prognosis).
Background to the Investigation
The protocol should continue to indicate the background of the research that is the rational cause on which the study is based. This section is written to answer some of these questions: what is the project about? What is already available in this field in current knowledge? Why do we need to overcome that data? and How will the community benefit from this study?
As in the case of an original research manuscript, the project introduction should include a brief literature review (with corresponding references). It is also essential to base the premises of the study, to underline the importance of the project in that specific period and, above all, of the materials and methods that will be used.
The justification must accurately highlight the current shortcomings in this field of scientific knowledge, following a precise and logical thread with concrete solutions on how to overcome the gaps and conclude with the project hypothesis. A different paragraph can be dedicated to references, paying attention to selecting only previous works that can help the reader focus attention on the topic and not overextend the list. In the references paragraph, the main studies relating to the object of the research should be inserted, but also reviews of the state of the art that update the most recent discoveries in the field.
The section should successively present the design of the study: monocentric or multicenter, retrospective or prospective, controlled or uncontrolled, open or blind, random or non-random, and observational or experimental. It should also be explained why that particular design has been chosen.
At this point, the author should include the main objective of the research, that is, the main goal of the study. This is a crucial part of the proposal and more than 4 or 5 objectives should be avoided so as not to detract from the accuracy of the project. Using verbs such as “demonstrate”, “evaluate”, “verify”, “improve”, “reduce” and “compare” helps to give relevance to this section. Also add a description of the general characteristics of the population that will participate in the study (if different subgroups are foreseen, the criteria into which they will be divided should be specified); the primary and secondary endpoints, including all variables representing the measure of objective (e.g., death from all causes, cardiovascular death, hospitalization, and side effects of a drug) follow in this section.
All individual parameters and variables to be evaluated during the study must be listed accurately and precisely, along with the tools, methods, process schedule and technical details with which they will be acquired; here, the author should explain how researchers working in the other centres involved have to send their results and acquired data to the central laboratory (e.g. filling in databases or sending images).
This section can be more complete by including a subsection that illustrates the expected results. Taking into account the basic idea of the project, the endpoints and the pre-established objectives, the author can explain how his research project:
It will contribute to optimizing scientific knowledge in that specific field
It will have real and successive implications in practice
Also, it paves the way for future scientific research in the same or a similar area of interest, etc.
The study population should be specified in detail, starting with the inclusion criteria (including age and sex if it is planned to restrict it) and the exclusion criteria: the more accurate the lists, the more accurate the enrollment of the subjects will be to avoid selection biases.
This will also contribute to increasing the success rate of the project and reducing the risks of statistical error during the successive analysis of the data. The sample size should be planned and justified on the basis of a statistical calculation that takes into account the incidence and prevalence of the disease, the frequency of use of a medicine, etc., and possibly also indicating whether the study considers a minimum or maximum number of subjects for each enrollment centre (in case of multicentre studies).
Security considerations (if applicable)
The safety of research participants is paramount. The safety aspects of the research should always be taken into account and information should be provided in the protocol on how the safety of the research participants will be ensured. This may include, for example, procedures for recording and reporting adverse events and their follow-up. It is helpful to remember that even the administration of a research questionnaire can have adverse effects on individuals.
The research protocol should clearly indicate what follow-up will be given to the research participants and for how long. This may include follow-up, especially for adverse events, even after data collection for the research study has ended.
Data management and statistical analysis
The protocol should provide information on how the data will be managed, including its handling and coding for computer analysis, tracking and verification. The proposed statistical methods for data analysis should be clearly described, including the reasons for the size of the selected sample, the power of the study, the level of significance to be used, the procedures for taking into account any missing or spurious data, etc. For projects that include qualitative approaches, specify in sufficient detail how the data will be analyzed.
The protocol should describe the quality control and assurance system for conducting the study, data management, etc.
Expected results of the study
The protocol should indicate how the study will contribute to the advancement of knowledge, how the results will be used, not only in publications, but also how they are likely to affect health care, health systems or health policies.
Dissemination of results and publication policy
The protocol should specify not only the dissemination of results in the scientific media, but also to the community and/or participants, and consider dissemination to policy makers where relevant. The publication policy should be clearly discussed, for example, who will take the initiative in the publication and who will be recognized in the publications, etc.
Duration of the project
The protocol should specify how long each phase of the project is likely to last, along with a detailed month-by-month calendar of each activity to be performed.
This section should set out the difficulties that researchers foresee in successfully carrying out their projects within the stipulated deadline and the requested funding. It must also offer possible solutions to address these difficulties.
This section should describe the role and responsibility of each team member
The protocol should contain a description of the ethical considerations related to the study. This should not be limited to providing information on how or from whom ethical approval will be obtained, but this section should document issues that are likely to raise ethical issues. It should also describe how the researcher or researchers plan to obtain informed consent from research participants (the informed consent process).
Informed Consent Forms
The approved version of the protocol must have copies of the informed consent forms (CRFs), both in English and in the local language in which they are to be administered. If the research involves more than one group of individuals, for example, healthcare users and providers, a separate informed consent form specifically tailored for each group should be included. This ensures that each group of participants receives the information they need to make an informed decision. For the same reason, each new intervention also requires a separate informed consent form.
The budget section should contain a detailed breakdown by item of the funds requested, together with a justification for each item.
Other aid to the project
This section should provide information on funding received or planned for this project from other funding organisations.
Collaboration with other scientists or research institutions
Links to other projects
Curriculum Vitae of researchers
The CV of the principal investigator and each of the co-investigators must be provided. In general, each CV should not have more than one page, unless a full CV is specifically requested.
Other research activities of researchers
The principal investigator must list all the research projects in which he currently participates, the source of funding for those projects, the duration of the projects and the percentage of time spent on each.
Financing and insurance
Financing and insurance, if not addressed in a separate agreement, should be described where relevant.
This section of the protocol should end with some indications about the schedule and duration of the study: Start and end date of enrollment, start and end date of inclusion, possible frequency of follow-up exams and timing of the analysis of the acquired data. If it has already been established, it may be useful to also indicate the type of statistical analysis that researchers will apply to the data.
It is always necessary to prepare an informed consent that will be proposed to the patient indicating the premises, methods and objectives of the research along with the advantages (for example, some free visits or diagnostic examinations) and the possible risks derived from participation in the study.
Section 3: Additional features of the study
Various data regarding the safety of the study should be added to this short section (a classification is essential in the case of studies that provide for the use of invasive procedures or the use of drugs). Generally, in the case of non-observational studies, insurance coverage should be taken into account.
If researchers have applied for or plan to apply for funding or financial support, all resources obtained should be listed to avoid conflicts of interest.
Writing a complete and detailed document is a primary step before starting a research project. The protocol, as described in this document, must be drafted simply and correctly, but it must clarify all aspects of it. The document could be divided into three different sessions to give all parties adequate attention.
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Al-Jundi A, Sakka S. Protocol writing in clinical research. J Clin Diagn Res. 2016;10:ZE10–3.
O’Brien K, Wright J. How to write a protocol. J Orthod. 2002;29:58–61.
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