Protocol Study

Protocols play a crucial role in delineating the research plan for a clinical study. Various funding organizations, such as the Health Research Authority (NHS), encourage the dissemination of study protocols to create a comprehensive record of the methodology and reduce duplication of research efforts. In the upcoming document, we will present a thorough explanation of the steps involved in developing a protocol research study.

A crucial element in any research project is the study protocol, which serves as a detailed description of the study’s methodology, ensuring that all team members are on the same page and follow the established procedures. Notably, prominent funding organizations like the NHS Health Research Authority in the United Kingdom actively encourage the publication of study protocols. This practice aims to create a documented record of the methodology, facilitate the publication of study findings, and prevent redundant research. The objective of this paper is to provide a clear understanding of the process involved in developing a research protocol by highlighting the essential components that need to be included.

CONTENTS OF A PROTOCOL RESEARCH STUDY

Introduction

The introduction section of a research paper is vital as it serves to establish the significance of the proposed research and provides the required contextual background based on existing evidence. It should be complemented by a background section that incorporates pertinent references to the existing literature. Conducting a thorough review of the available evidence is crucial to support the necessity of the planned research. Subsequently, a succinct overview of the study and the target population should be provided. Moreover, it is essential to offer a clear rationale for the project, including a description of the research question and a justification for the study’s importance.

Methods and analysis

Selecting an appropriate study design and methodology that aligns with the research objectives is crucial. In this section, it is important to explain the chosen study design, including whether it is a single-center or multicenter study, retrospective or prospective, controlled or uncontrolled, randomized or non-randomized, and observational or experimental. Justification for the selected design should be provided, emphasizing its suitability for the research objectives.

Clearly defining the studied population is essential, which involves establishing specific inclusion and exclusion criteria. These criteria outline the characteristics of the population under investigation and contribute to the study’s applicability for readers. If feasible, a sample size calculation using a power calculation should be performed to determine an appropriate sample size.

The protocol should outline the process of patient screening, including the methods, timing, and locations for recruitment. In the case of a multicenter study, all participating units should adhere to the same recruitment model, or any differences should be explicitly described in the protocol. Informed consent must be obtained from each individual before their participation in the study. The protocol should provide a comprehensive description of the process of obtaining informed consent, including the provision of a patient information sheet and the assessment of the individual’s capacity to provide consent.

The intervention being studied should be described in sufficient detail to allow external individuals or groups to replicate the study. Any deviations from routine care should be explained. Primary and secondary outcomes should be clearly defined, along with an explanation of their clinical relevance. Detailed descriptions of data collection methods and the secure storage of data should be included in the protocol. Additionally, the protocol should outline the statistical methods to be used in data analysis. Plans for reporting, collecting, and managing any reported adverse events or unintended effects of trial interventions or conduct should also be addressed.

Ethics 

The protocol should provide a clear and comprehensive explanation of the risks and benefits associated with participation in the study, ensuring the well-being and safety of the participants. It should address any specific ethical considerations relevant to the research, emphasizing the importance of upholding ethical standards throughout the study. The protocol should explicitly state the approvals that the research has obtained, with the minimum expectation being ethical and local research approvals. In the case of multicenter studies, the protocol should also include a statement on how the protocol aligns with the requirements to obtain approval to conduct the study at each proposed site.

To ensure confidentiality, the protocol should outline the procedures for collecting, sharing, and maintaining personal information about potential and enrolled participants. It should specify who owns the data generated from the study and define the duration for which the data will be stored. Additionally, it is advisable to explain that upon completion of the study, the data will be analyzed, and a final study report will be prepared. Consideration should be given to plans for notifying participants of the study’s outcomes, whether through the provision of the publication or via other means of communication.

The protocol should establish transparent and fair criteria for authorship of any resulting publication. Describing these criteria in this section of the protocol will help address any potential issues that may arise during the publication stage, ensuring proper acknowledgment of the contributions made by the research team members.

Funding statement

Providing clear information about the study sponsors and funders is essential to ensure transparency and accountability. In the protocol, it is important to explicitly explain the involvement and potential influence of each party. The sponsor, which refers to the institution or organization assuming overall responsibility for the study, should be identified to establish transparency and accountability.

The protocol should outline the roles and responsibilities of any funders in various aspects of the study, including study design, data analysis and interpretation, manuscript writing, and dissemination of results. This information helps clarify the extent of their involvement in the research process and ensures transparency.

Additionally, any competing interests of the investigators should be stated in this section of the protocol. This is necessary to disclose any personal or financial interests that could potentially influence the study’s design, conduct, or reporting. By doing so, transparency is maintained, and readers can assess any potential conflicts of interest that may arise.

CONCLUSION

The importance of a study protocol lies in its ability to provide a comprehensive research plan for a clinical study. Creating a detailed document that encompasses all the necessary information is crucial for proper study execution. Many funders actively encourage researchers to publish their study protocols, as it serves to establish transparency and promote research reproducibility. By making study protocols publicly available, researchers contribute to the overall advancement of scientific knowledge and enable others to replicate and build upon their work.