A. Describe the four phases (Phase I, II, III, and IV) of a clinical trial for a healthcare environment.

1. Create a diagram showing the four phases of a clinical trial.

2. Discuss how each of the four ethical principles in research should be followed in clinical trials.

3. Explain how a clinical trials team uses clinical trials databases for information on trials.

4. Describe how each of the 14 areas of the informed consent procedure applies to the clinical trial process.

5. Explain the importance of HIPAA Privacy and Security Rules in clinical trials.

6. Create a chart that shows three differences between exempt research and expedited research of Institutional Review Board submissions.

B. Develop a survey packet to gather appropriate responses on the clinic’s interest in participating in clinical trials by doing the following:

1. Develop a cover letter (suggested length of 1–2 pages) to accompany the survey that includes the following:

• letterhead

• purpose of survey

• study’s importance

• participant’s importance

• sponsor(s)

• time to complete

• time frame(s)

• contact information

• survey instructions

2. Create a survey with eight total questions, including the following:

• three true/false questions

• three multiple-choice questions

• two open-ended questions (e.g., essay, fill-in-the-blank, short answer, scale)

3. Describe the statistical methods you would use to evaluate the survey results.

4. Explain the potential benefits of conducting interviews with your survey.

a. Justify whether conducting interviews would be appropriate for your survey from part B2.

C. Acknowledge sources, using APA-formatted in-text citations and references, for content that is quoted, paraphrased, or summarized.

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Laboratory assignments will be completed as TYPED reports with the following sections:

1. Project (location, description, participants)

2. Project Conditions (project status, weather, on day visited)

3. Answers to specific questions for the lab

4. Summary and conclusions

The lab report can be as long as needed in order to complete the assignment. Professional

work is expected. Use a table of contents, figures and tables should be referenced and

have captions, and so on. You may have attachments, which should be neat, clean, and

firmly attached

Figures: Project description with photos and maps as needed, provide photos for all items

requested.

Safety toolbox: Reference OSHA section numbers, answer all questions with sufficient detail,

use appropriate figures.

2. Appearance and organization:

Professional Appearance: Typed, not congested, not much empty space, use paragraphs

Well organized/easy to find things: TOC, LOF, page numbers, section titles, items discussed in

correct order, attachments well organized.

Use of figures: Figures and tables are numbered, captioned, and referenced in the text, set in

line with text (do not wrap with text).

3. Language: Use technical writing style, short and clear sentences, use correct spelling and grammar, use

paragraphs.

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