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 clinicâ€™s interest in participating in clinical trials by doing the following:
1. Develop a cover letter (suggested length of 1â€“2 pages) to accompany the survey that includes the following:
â€¢ purpose of survey
â€¢ studyâ€™s importance
â€¢ participantâ€™s importance
â€¢ time to complete
â€¢ time frame(s)
â€¢ contact information
â€¢ survey instructions
2. Create a survey with eight total questions, including the following:
â€¢ three true/false questions
â€¢ three multiple-choice questions
â€¢ 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.