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UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD NEW RESEARCH STUDY PROTOCOL REVIEW FORM IRB Number: SECTION A: Project Protocol Information N LY TITLE OF PROJECT / PROTOCOL:
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How to fill out new research study protocol

How to fill out a new research study protocol:
01
Understand the purpose and objectives of the research study: Before filling out the protocol, it is essential to have a clear understanding of the main goals and objectives of the research study. This will help guide you in providing the necessary information in the protocol.
02
Provide the background and rationale: Begin by outlining the background and rationale for the research study. This includes explaining the significance of the research question, any previous studies or gaps in knowledge, and the rationale behind conducting the current study.
03
Define the research question and objectives: Clearly state the research question that the study aims to answer. In addition, outline the specific objectives that will help address the research question effectively. These objectives should be specific, measurable, achievable, relevant, and time-bound (SMART).
04
Describe the study design and methodology: Provide a detailed description of the study design and methodology that will be used to conduct the research. This includes specifying whether it is a qualitative or quantitative study, the sample size and selection criteria, data collection methods, data analysis procedures, and any ethical considerations.
05
Outline the data collection instruments: Specify the data collection instruments that will be used in the study, such as surveys, interviews, or observation protocols. Include details on how these instruments will be developed, validated (if necessary), and administered to participants.
06
Explain participant recruitment and informed consent procedures: Describe how participants will be recruited for the study, including any inclusion or exclusion criteria. Outline the process for obtaining informed consent from participants, ensuring that they are fully aware of the study's purpose, procedures, potential risks, and benefits.
07
Address ethical considerations: Discuss any ethical considerations associated with the research study, such as protection of participant privacy and confidentiality, potential conflicts of interest, and any required ethical approvals or licenses.
08
Detail the data analysis plan: Provide a clear plan for how the collected data will be analyzed. This may involve describing the statistical methods or qualitative analysis techniques that will be used, as well as any software or tools required for data analysis.
09
Outline the timeline and budget: Create a timeline that outlines the start and end dates for each phase of the research study. Additionally, provide a budget estimation that includes necessary resources, such as personnel, materials, equipment, and any anticipated expenses.
Who needs a new research study protocol?
Researchers and research teams who are planning to conduct a new study need a research study protocol. The protocol serves as a comprehensive document that outlines the various aspects of the study, including the objectives, methodology, data collection instruments, ethical considerations, and data analysis plan. It provides a standardized framework to ensure that the study is conducted consistently and ethically, and it also serves as a guide for obtaining necessary approvals from research ethics committees or institutional review boards. The research study protocol is essential for maintaining transparency, reproducibility, and rigor in research.
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What is new research study protocol?
A new research study protocol is a detailed plan outlining the objectives, methods, procedures, and design of a research study.
Who is required to file new research study protocol?
Researchers, investigators, or institutions conducting the research study are required to file a new research study protocol.
How to fill out new research study protocol?
To fill out a new research study protocol, researchers need to provide detailed information on the study's purpose, methodology, participants, risks, benefits, and ethical considerations.
What is the purpose of new research study protocol?
The purpose of a new research study protocol is to ensure that the study is conducted ethically, safely, and in compliance with regulatory requirements.
What information must be reported on new research study protocol?
Information such as study objectives, methodology, participant recruitment and selection criteria, risks and benefits, data collection procedures, and ethical considerations must be reported on a new research study protocol.
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