Creating good policies takes time and effort, but you can increase your chances for success by remembering a few basics. Employees would wear whatever they want to work, and behave according to their own rules. If the client’s continues the drug on subsequent visits, the nurse must reorder the drug based on the nurse protocol. Some suggestions for improving performance and accountability, SPIRIT 2012 explanation and elaboration: guidance for protocols of clinical trials, The Value of Statistical Analysis Plans in Observational Research Defining High-Quality Research From the Start, Hoffman et al. For example, if blood pressure will be measured, it is important to state the subject"s condition (resting for at least 5 minutes), position (seated), arm (left) and technique (mercury sphygmomanometer).. How and what data will be collected (i.e. Is the schedule (interval, frequency, duration, or timing) of the intervention clear? Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Writing the research protocol 5.1 Introduction After proper and complete planning of the study, the plan should be written down. The plan includes the definitions of an adverse event, serious adverse event and summarizes the reporting requirements and timelines. Sample Size and Power: All studies require a justification for the chosen sample size. While the intent of an SOW is to give an overall description of a project, the key to writing one is to keep it clear and precise. The primary objective serves as the basis of the sample size. Primary Aim. Review the flowcharts that you have created with the process owners for accuracy. The general advice is applicable to the other protocol templates. Purpose of the Study Protocol. Her work appears in "The Multi-Generational Workforce in the Health Care Industry," and she has been cited in numerous publications, including journals and textbooks that focus on human resources management practices. Conduct the interviews and document the results. 8.2 Adverse Event Reporting The study design is cross-sectional, meaning that there is just one study visit. M References. The background and rationale should be no more than 3 - 5 pages. Generally speaking, procedures consist of several steps instead of just one action. Create a flowchart that depicts the input to the process, the work steps, and the output. Introduction. Antes and Chalmers. Protocol and procedures may seem synonymous, but they are really not. It is important to think of a protocol (may it be wet or dry lab-based, biology or chemistry-focused, simple or advanced) as a brief, modular and self-contained scientific publication. C) Objectives. Steps to Writing a SOP: 1. Review laboratory protocols and identify the potential hazards associated with the procedures performed in the protocols — Risk Assessment. The full title should be concise, but it should also provide readers with an accurate summary of the study, including the study design, drug product to be tes… Developing a protocol or procedure involves documenting the details associated with putting company policies into action. What is it that you need to know to write a detailed procedure? The objectives need to be specific to the intervention - for a drug, they should specify the dosage level, route, frequency and duration of administration and in a defined population - "does the study drug reduce blood pressure when administered twice a day as an oral liquid, at a dose of 50 mg, in children age 6 - 12 years who have moderate hypertension". This section provides a brief overview of the entire study design including various phases of the study (if more than one). Enough detail should be present in the protocol to allow another investigator to replicate the study without consulting the investigator. Ruth Mayhew has been writing since the mid-1980s, and she has been an HR subject matter expert since 1995. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. Clinical research is either experimental or observational. of the writing of the protocol to reflect more closely the sense of the study. This section is a Visit Schedule which is visit-by-visit listing of all the procedures that will take place at each visit. Primary Aim. Write a Protocol. If the study will have multiple procedures in one day (e.g. Philadelphia, PA 19104. A protocol is a set of rules that enables effective communications to occur. Psychological or other measurement scales that will be used should be described. The title should be able to stand alone as an explanation of the study. Study Abstract. Continually refining protocol can ensure that you are sustaining the quality of performance that will benefit your company's business reputation and its bottom line. Writing a clinical research protocol is a complex and time consuming process. Review the flowcharts that you have created with the process owners for accuracy. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication.