Protocol Writing in Clinical Research

Abstract

Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.A protocol is directed by a chief researcher. The health of the participants' will be regularly checked by members of the research team to ultimately ensure the study's safety and effectiveness. Purpose of a Research Proposal[ ABstRActWriting a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition.[table/ Fig-1]: Aims of the protocol.[table/ Fig-3]: The components of the protocol. Aims 1)To raise the question to be researched and clarify its importance.2) To collect existing knowledge and discuss the efforts of other researchers who have worked on the related questions (Literature review). 3) To formulate a hypothesis and objectives. 4) To clarify ethical considerations. 5) To suggest the methodology required for solving the question and achieving the objectives. 6) To discuss the requirements and limitations in achieving the objectives. BenefitsAllows the researcher to plan and review the project's steps. Serves as a guide throughout the research. Forces time and budget estimates.The key points of the proposal should include justification for the need of the project and a detailed plan for the investigation [1,2]:

The detailed clinical objectives approach to designing clinical trials and choosing estimands

“…Al‐Jundi et al 19 also identify the problem and suggest a remedy through use of the management concept of SMART objectives; that they are Specific, Measurable, Achievable, Relevant, and Time‐based. Although it is hard to disagree with the necessity of the SMART criteria, again these focus on the patient outcome described by an objective, and we believe an approach more tailored to clinical trials would provide additional benefit.…”

A Scientific Approach and Perception for Clinical Practice in India

“…Sponsor and/or institute has the authority for any decisions concerning the TMF. Appendices and amendments 36,37 Bioanalytical estimation After complete conduction of the study, the further processing is carried out by the bioanalytical department whose tasks include isolation of plasma from the blood sample and drug extraction by three preliminary methods: 1) Solid phase extraction method (SPE): In this technique separation of desired constituent from a solid sample is achieved by extraction with an organic solvent in which the solubility of other substances present in the sample is negligible. In this technique, hydrophobic functional groups are chemically bonded to a solid surface (eg: powdered silica), these groups will interact with hydrophobic organic compounds by van der waals forces of interaction and extract them from the aqueous sample.…”

A road map for designing and reporting clinical trials in paediatric dentistry

“…Firstly, is the question being asked important enough to justify the resources that will be required to answer it? Secondly, the accuracy of the question being asked is used to design the trial 10 …”

“…Hand in hand with this, patient and other stakeholder groups, however, should be consulted and the UK's National Institute for Health Research has helpful information to support public involvement in research 13 . Also, the Feasible, Interesting, Novel, Ethical and Relevant framework is a useful tool to guide researchers in not only building a good question but considering other important aspects for designing clinical trials 10 …”