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This study aims to evaluate the efficacy of an integrative exercise program compared to an illness management and recovery program for improving quality of life, PTSD symptoms, cardiovascular health, and overall well-being among combat veterans with PTSD. The study involves a randomized controlled trial design, with key measures including exercise capacity, quality of life, and subjective sleep quality. The integrative exercise program combines aerobic exercise with mindfulness and breath...
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01
Define the study objectives clearly.
02
Identify the study design (e.g., observational, experimental).
03
Determine the target population and sample size.
04
Develop inclusion and exclusion criteria for participants.
05
Specify the data collection methods and tools.
06
Outline the statistical analysis plan (e.g., types of analysis, software to be used).
07
Detail any potential ethical considerations and obtain necessary approvals.
08
Write a timeline for the study implementation.
09
Review and revise the protocol for clarity and completeness.

Who needs study protocol and statistical?

01
Researchers conducting clinical trials.
02
Institutional Review Boards (IRBs) for ethical approval.
03
Funding agencies reviewing grant applications.
04
Regulatory bodies ensuring compliance with health regulations.
05
Collaborators involved in the study.
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A study protocol is a document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. It serves as a blueprint for the trial, ensuring that it is conducted consistently and ethically. Statistical details within the protocol outline the statistical methods that will be used for data analysis.
Researchers or institutions conducting clinical trials are required to file a study protocol and statistical. This typically includes sponsors, principal investigators, and any affiliated research organizations.
To fill out a study protocol and statistical, researchers should follow guidelines and templates provided by regulatory agencies. They need to include sections for study objectives, design, methodology, statistical analyses, and timelines, ensuring that all required information is clearly presented and compliant with regulations.
The purpose of a study protocol and statistical is to provide a clear and comprehensive plan for conducting a clinical trial. It ensures scientific integrity, outlines the rationale and methods for the study, and allows for transparency and reproducibility in research.
The information that must be reported includes the study title, objectives, design, methodology, sample size justification, statistical analysis plan, timelines, and any ethical considerations, along with details about the investigators and funding sources.
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