Get the free New Research Study Protocol Review bFormb 6-2006 - UNT Health bb

UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD NEW RESEARCH STUDY PROTOCOL REVIEW FORM IRB Number: SECTION A: Project Protocol Information TITLE OF PROJECT / PROTOCOL:

How to fill out new research study protocol

Point 1: Familiarize yourself with the purpose and objective of the research study protocol. Understand the specific requirements and guidelines that need to be followed in order to ensure the validity and ethical conduct of the study.

Point 2: Gather all relevant information and documents that are necessary to complete the research study protocol. This may include details about the study design, participant recruitment and selection criteria, data collection and analysis methods, and any necessary approvals or permissions.

Point 3: Begin by filling out the basic details of the research study protocol, such as the title, investigator(s) names and affiliations, study sponsor information, and contact details for any queries or clarifications.

Point 4: Clearly outline the background and rationale for the research study. Explain why the study is important, what knowledge gap it aims to address, and the potential impact or benefits it may have in the field of study.

Point 5: Describe the study objectives and research questions that the protocol aims to answer. Clearly state the primary and secondary outcomes of the study, and any specific hypotheses to be tested.

Point 6: Provide a detailed description of the study design and methodology. This should include information about the study population, sample size calculations, inclusion and exclusion criteria, randomization or allocation procedures, data collection methods, and statistical analysis plan.

Point 7: Explain the ethical considerations and measures that will be taken to protect the rights and well-being of the participants. Describe the informed consent process, any potential risks or benefits, confidentiality measures, and procedures for handling adverse events.

Point 8: Include a section on data management and quality assurance. Outline how the data will be collected, stored, and analyzed. Specify any quality control measures, data monitoring committees, or audits that will be implemented to ensure the accuracy and integrity of the study data.

Point 9: Provide a clear timeline for the study, including key milestones, data collection periods, and anticipated completion dates. This will help to ensure that the study stays on track and can be effectively monitored or reviewed.

Point 10: Finally, review the completed research study protocol for accuracy, clarity, and consistency. Make sure that all necessary information has been included and that the protocol adheres to any specific formatting or submission requirements.

Who needs new research study protocol?

1. Researchers who are planning to conduct a new research study need a research study protocol to outline the details and methodology of their study.
2. Institutional review boards (IRBs) or ethics committees require a research study protocol to evaluate the ethical aspects of the study and ensure participant protection.
3. Funding agencies or grant committees may request a research study protocol to assess the scientific rigor and feasibility of the study before providing financial support.
4. Regulatory bodies or government agencies may require a research study protocol to review and approve the study's compliance with legal and ethical standards.
5. Collaborating researchers or study team members need the research study protocol to understand their roles and responsibilities and ensure consistency in the study implementation.

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What is new research study protocol?

A new research study protocol is a detailed plan outlining the objectives, methods, and procedures for a new research study.

Who is required to file new research study protocol?

Researchers conducting a new research study are required to file the new research study protocol.

How to fill out new research study protocol?

The new research study protocol should be filled out with detailed information on study objectives, methods, procedures, 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 in a scientifically sound and ethical manner.

What information must be reported on new research study protocol?

The new research study protocol must include detailed information on study objectives, methods, procedures, participant recruitment, and data analysis.