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This document is a submission form for research protocols involving human subjects at Northwest Community Hospital. It outlines required information regarding the study's title, investigators, methods,
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How to fill out research protocol submission form

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How to fill out RESEARCH PROTOCOL SUBMISSION FORM

01
Obtain the RESEARCH PROTOCOL SUBMISSION FORM from the relevant institutional website or office.
02
Read all instructions carefully before filling out the form.
03
Provide your personal information, including your name, department, and contact details.
04
Specify the title of the research project clearly.
05
Describe the objectives and goals of the study in concise terms.
06
Outline the research methodology, including study design and data collection methods.
07
Include information about the study population and sample size.
08
Address any ethical considerations and how you will ensure participant confidentiality.
09
Provide a timeline for your research activities.
10
Review the filled form for completeness and accuracy before submission.

Who needs RESEARCH PROTOCOL SUBMISSION FORM?

01
Researchers planning to conduct studies involving human or animal subjects.
02
Faculty members requesting approval for academic research.
03
Graduate students submitting research proposals as part of their academic requirements.
04
Institutional review boards (IRBs) or ethics committees reviewing proposed research.
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According to ICH GCP guidelines, a study protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research study.
The study protocol should contain in details the background, the objective, the rationale and the importance, as well as the design, the methodology, the Institutional Review Board approval, the informed consent and the statistical considerations of the RCT.
A reasonable structure for a protocol would be as follows: Title. Name of applicant/supervisors/affiliations/version number. Introduction. Method. Participants. Design. Materials (if relevant) Procedure. Proposed analysis. Practical issues (e.g., costs/logistics) Ethical concerns. Timescale.
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
It should answer the question of why and what: why the research needs to be done and what will be its relevance. The magnitude, frequency, affected geographical areas, ethnic and gender considerations, etc of the problem should be followed by a brief description of the most relevant studies published on the subject.
Title page. Title of the module, title of the practical, student name, tutor name. Introduction. Short (1-2 pages) introduction of the topic and the main question asked in the practical course. Material and Methods. Presentation of all methods and materials used. Results. Discussion. References. Figures. Figure legends.
Protocol summary: Give a concise overview of the project. Describe the purpose of the study, including problem to be investigated and hypothesis(es) to be tested, the population, and the methods that will be used. Avoid the use of acronyms. Include the expected benefit of the study.
The Common Protocol Template (CPT) is a harmonized and streamlined approach to the format and content of clinical trial protocols.

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The RESEARCH PROTOCOL SUBMISSION FORM is a document that researchers must complete to outline the details of their proposed study, including its objectives, methodology, and ethical considerations.
Researchers conducting studies involving human subjects or animals, as well as those requiring institutional review board (IRB) approval, are required to file the RESEARCH PROTOCOL SUBMISSION FORM.
To fill out the RESEARCH PROTOCOL SUBMISSION FORM, researchers should follow the outlined sections, providing detailed information about the study design, participant recruitment, data collection methods, and safety measures. It is important to adhere to any specific guidelines provided by the oversight institution.
The purpose of the RESEARCH PROTOCOL SUBMISSION FORM is to ensure that research studies are ethically sound and scientifically valid, allowing review bodies to assess potential risks and benefits to participants.
The RESEARCH PROTOCOL SUBMISSION FORM must report information including research objectives, methodology, participant demographics, data collection processes, potential risks and benefits, and any funding sources or conflicts of interest.
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