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Research Process
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The research process often begins with a very broad idea for a topic you’d like to know more about. You do some preliminary research to identify a problem.
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A Beginner's Guide to Starting the Research Process
Research
When you have to write a thesis or dissertation, it can be hard to know where to begin, but there are some clear steps you can follow. The research process often begins with a very broad idea for a topic you’d like to know more about. You do some preliminary research to identify a problem. After refining your research questions, you can lay out the foundations of your research design, leading to a proposal that outlines your ideas and plans. This article takes you through the first steps of the research process, helping you narrow down your ideas and build up a strong foundation for your research project.
How are Medical Device Clinical Trials categorized?
Medical device clinical trials (MDCTs) are investigations or examinations undertaken to assess the safety or the performance of a medical device in terms of its use in treatment, prevention or diagnosis of diseases in human subjects.
MDCTs are different from drug trials in that only patients with the condition which the device is designed to treat are involved. MDCTs are traditionally comprised of three different types of studies:
• Exploratory or Feasibility Study – Exploratory studies (also knowns as feasibility studies) are conducted in the early stages of the medical device development. They are used to establish preliminary safety and effectiveness of the device and to design the next stage of the trial, the pivotal study.
• Pivotal Study – Pivotal studies are performed to demonstrate the device safety and effectiveness in terms of its specific use within a specific patient population. The results obtained from a pivotal study are used to gain regulatory approval to market the device.
• Post-market Study – Post-market study could run either as a condition of approval to meet a business objective, or to better understand long-term effectiveness of the device and potential adverse events associated with the use of the device.
Being familiar with the specifications and format of drug and MDCTs can help all participants (including medical professionals, clinical staff and patients) ensure the trials run as smoothly and efficiently as possible.
Steps For Research
Step 1: Choose your topic
First you have to come up with some ideas. Your thesis or dissertation topic can start out very broad. Think about the general area or field you’re interested in—maybe you already have specific research interests based on classes you’ve taken, or maybe you had to consider your topic when applying to graduate school and writing a statement of purpose.
Even if you already have a good sense of your topic, you’ll need to read widely to build background knowledge and begin narrowing down your ideas. Conduct an initial literature review to begin gathering relevant sources. As you read, take notes and try to identify problems, questions, debates, contradictions and gaps. Your aim is to narrow down from a broad area of interest to a specific niche.
Make sure to consider the practicalities: the requirements of your programme, the amount of time you have to complete the research, and how difficult it will be to access sources and data on the topic. Before moving onto the next stage, it’s a good idea to discuss the topic with your thesis supervisor.
Step 2: Identify a problem
So you’ve settled on a topic and found a niche—but what exactly will your research investigate, and why does it matter? To give your project focus and purpose, you have to define a research problem.
The problem might be a practical issue—for example, a process or practice that isn’t working well, an area of concern in an organization’s performance, or a difficulty faced by a specific group of people in society.
Alternatively, you might choose to investigate a theoretical problem—for example, an underexplored phenomenon or relationship, a contradiction between different models or theories, or an unresolved debate among scholars.
To put the problem in context and set your objectives, you can write a problem statement. This describes who the problem affects, why research is needed, and how your research project will contribute to solving it.
Step 3: Formulate research questions
Next, based on the problem statement, you need to write one or more research questions. These target exactly what you want to find out. They might focus on describing, comparing, evaluating, or explaining the research problem.
A strong research question should be specific enough that you can answer it thoroughly using appropriate qualitative or quantitative research methods. It should also be complex enough to require in-depth investigation, analysis, and argument. Questions that can be answered with “yes/no” or with easily available facts are not complex enough for a thesis or dissertation.
In some types of research, at this stage you might also have to develop a conceptual framework and testable hypotheses.
Step 4: Create a research design
The research design is a practical framework for answering your research questions. It involves making decisions about the type of data you need, the methods you’ll use to collect and analyze it, and the location and timescale of your research.
There are often many possible paths you can take to answering your questions. The decisions you make will partly be based on your priorities. For example, do you want to determine causes and effects, draw generalizable conclusions, or understand the details of a specific context?
You need to decide whether you will use primary or secondary data and qualitative or quantitative methods. You also need to determine the specific tools, procedures, and materials you’ll use to collect and analyze your data, as well as your criteria for selecting participants or sources.
Step 5: Write a research proposal
Finally, after completing these steps, you are ready to complete a research proposal. The proposal outlines the context, relevance, purpose, and plan of your research.
As well as outlining the background, problem statement, and research questions, the proposal should also include a literature review that shows how your project will fit into existing work on the topic. The research design section describes your approach and explains exactly what you will do.
You might have to get the proposal approved by your supervisor before you get started, and it will guide the process of writing your thesis or dissertation.