FDA

IHP 600 Paper Guidelines and Rubric

Select one of the two topics for your paper.

Topic One: FDA Legislation

Review Exhibit 5.3 in the textbook. Pick two of the identified legislations and explain their impact today.

Topic Two: Safety Considerations

As a primary benchmark, benefits must outweigh any negative consequences. Research and evaluate the use of clinical trials as tools for evaluating the efficacy of medical technology as it applies to patient safety. Requirements of submission: Paper assignments must follow these formatting guidelines: double spacing, 12-point Times New Roman font, one-inch margins, and discipline-appropriate citations (APA format). Page length requirements: 5 - 7 pages graduate courses. (This does not include the cover page or the reference list.)

Critical Elements Exemplary (100%) Proficient (90%) Needs Improvement (70%) Not Evident (0%) Value

Main Elements Includes all of the main elements and requirements and cites multiple examples to illustrate each element

Includes most of the main elements and requirements and cites many examples to illustrate each element

Includes some of the main elements and requirements

Does not include any of the main elements and requirements

25

Inquiry and Analysis

Provides in-depth analysis that demonstrates complete understanding of multiple concepts

Provides in-depth analysis that demonstrates complete understanding of some concepts

Provides in-depth analysis that demonstrates complete understanding of minimal concepts

Does not provide in-depth analysis

20

Integration and Application

All of the course concepts are correctly applied

Most of the course concepts are correctly applied

Some of the course concepts are correctly applied

Does not correctly apply any of the course concepts

10

Critical Thinking Draws insightful conclusions that are thoroughly defended with evidence and examples

Draws informed conclusions that are justified with evidence

Draws logical conclusions, but does not defend with evidence

Does not draw logical conclusions

20

Research Incorporates many scholarly resources effectively that reflect depth and breadth of research

Incorporates some scholarly resources effectively that reflect depth and breadth of research

Incorporates very few scholarly resources that reflect depth and breadth of research

Does not incorporate scholarly resources that reflect depth and breadth of research

15

Writing (Mechanics/Citations)

No errors related to organization, grammar and style, and citations

Minor errors related to organization, grammar and style, and citations

Some errors related to organization, grammar and style, and citations

Major errors related to organization, grammar and style, and citations

10

Earned Total: 100