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AD___ Award Number: W81XWH1010881TITLE: A Randomized Controlled Trial (ACT) to Assess and Improve the Effectiveness of Postdeployment Screening for Mental IllnessPRINCIPAL INVESTIGATOR: Dr. Roberto
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01
Start by identifying the purpose and objectives of the study protocol.
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Include a clear and concise title for the protocol.
03
Provide a background and rationale for the study, including any relevant literature or previous research.
04
Clearly outline the study design, including the type of study (e.g., observational, experimental) and the study population.
05
Specify the inclusion and exclusion criteria for participant selection.
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Describe the interventions or procedures that will be performed during the study.
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Define the primary and secondary outcomes of the study.
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Detail the data collection methods and tools that will be used.
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Include a plan for participant recruitment and informed consent.
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Provide a timeline for the study, including key milestones and data analysis.
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Specify any ethical considerations and approval processes that need to be followed.
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Finally, review the protocol for accuracy and completeness before submission.

Who needs study protocol for a?

01
Researchers conducting clinical trials or any type of research study require a study protocol. It helps provide a structured plan and ensures that the study is conducted in a systematic and ethical manner.
02
Ethics committees and institutional review boards also require study protocols to review and approve the study before it can proceed.
03
Funding agencies may also require a study protocol to assess the feasibility and scientific merit of the proposed research.
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Additionally, regulators such as the Food and Drug Administration (FDA) may require study protocols as part of the approval process for new drugs or medical devices.
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A study protocol is a detailed plan that outlines the objectives, design, methodology, statistical considerations, and organization of a research study.
Typically, the principal investigator or the research team lead is required to file the study protocol.
To fill out a study protocol, one must provide information on the study's objectives, participant criteria, methods, analysis plan, and ethical considerations.
The purpose of a study protocol is to ensure clarity and consistency in the research process, serve as a guide for conducting the study, and facilitate ethical compliance.
Required information includes study title, objectives, design, methodology, participant criteria, statistical analysis plan, and ethical considerations.
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