Task 1: Clinical Trials
Health informatics professionals may work closely with clinical trial professionals because of their expertise in managing health information. Their role on the clinical trials team will vary depending on the type of research being performed within the healthcare organization. They may help to develop research study protocol and consent forms, or they may serve more as an educational resource to medical providers and patients. They can serve as a consultant at all levels of clinical research because they are subject matter experts in data and information handling and in patient confidentiality and privacy matters.
Your submission must be your original work. No more than a combined total of 30% of the submission and no more than a 10% match to any one individual source can be directly quoted or closely paraphrased from sources, even if cited correctly. Use the Turnitin Originality Report available in Taskstream as a guide for this measure of originality.
You must use the rubric to direct the creation of your submission because it provides detailed criteria that will be used to evaluate your work. Each requirement below may be evaluated by more than one rubric aspect. The rubric aspect titles may contain hyperlinks to relevant portions of the course.
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:
• purpose of survey
• study’s importance
• participant’s importance
• 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.
1. IFT Task 1 Rubric link opens in new window
* 1. The phase one involves using a small group, which is crucial as it helps with establishing aspects such as dosage, side effects and safety of the drug (U.S. National Library of Medicine, 2017). In the second stage the drug is administered to a large group to establish level of safety and effectiveness. In the third phase the sample size is large and this is used to evaluate the effectiveness, compare treatments monitor effects along with collecting information which allows the use of drug safely. In the fourth phase studies are carried out the effects of the drug in the society especially after a long-time use (U.S. National Library of Medicine, 2017).
3968151225043Phase two, large group of people to establish safety and effectiveness 00Phase two, large group of people to establish safety and effectiveness 47435795406Phase one, small group of people to establish side effects, dosage and safety. Phase one, small group of people to establish side effects, dosage and safety.
453774256672Phase four, carry out studies to establish drugs effect on various populations, check for side effects especially with long term use. Phase four, carry out studies to establish drugs effect on various ...