Research background of the study

    • [DOCX File]NIDCR Clinical Study Observational Protocol

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      Principal Investigators and Study Staff. Details. This document is the National Institute of Dental and Craniofacial Research (NIDCR) protocol template for an observational study. In an observational study, the investigator does not alter the care that people receive, but simply records observations and analyzes data.

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    • [DOC File]Sample Protocol Template - NHLBI, NIH

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      Study Abstract. Primary Hypothesis. Purpose of the Study Protocol. Background. Prior Literature and Studies. Rationale for this Study. Study Objectives. Primary Aim. Secondary Aim. Rationale for the Selection of Outcome Measures. Investigational Agent . Preclinical Data. Clinical Data to Date . Dose Rationale and Risk/Benefits . Study Design ...

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    • [DOC File]Descriptive Research Protocol

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      Main study outcome measures (assessments of primary and key secondary endpoints) Background Information and Rationale. The background and rationale should be approximately 3 – 5 pages. Introduction. Brief paragraph or two to describe the setting and rationale for the study. The details of the background go into Section 1.2 . Relevant ...

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    • [DOC File]Clinical Research Protocol

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      Background and Study Rationale. The introduction should state that the study is a retrospective research study/chart review. State that the study will be reviewed and approved by the IRB and will be conducted in accordance with all applicable University of Pennsylvania human subjects research requirements as well as applicable federal regulations.

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    • [DOC File]THE RESEARCH PROPOSAL TEMPLATE

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      The full research proposal must be between 5 and 10 pages and should present the following: Title . Brief Introduction. Background and statement of the problem (this in the light of a thorough literature review) Research question or hypothesis, aim and objectives. Study design (type of study) Study population and sampling

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    • [DOC File]Study Protocol Template

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      Research Team: Abstract Provide a summary of the study background, aims, and design. ... Describe all study procedures, assessments, and subject activities. Provide a schedule of all study assessments and subject activities, including …

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