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Describe the lifecycle of the biospecimen(s) starting with inclusion/exclusion criteria of the donor, how a biospecimen was collected, labeled, processed, stored and quality assessed.

July 22, 2021
Christopher R. Teeple

Read critically the paper “The Mayo Clinical Biobank” (Olson, 2014) and retrace the major steps and tasks that have been critical for the startup, building, and the operational stages of the Mayo Clinic Biobank (MCB).
1. Create the Mayo Clinic Biobank (MCB) lifespan and provide grossly estimated timelines for planning, building and operating the MCB. (10 points)
2. Outline the design and scope of the MCB study: is this a prospective or retrospective study? (5 points)
3. Are the biospecimens linked or unlinked to personal health information? (5 points)
4. Classify the biobank type of the MCB (disease-based, population-based, or neither). (10 points)
5. The recommendations of the Deliberative Community Engagement (DCA) have been taken into consideration and have been incorporated into the content of the Informed Consent document for the MCB. This was done during which stage of establishing the MCB and with what goal? (10 points)
6. Develop a timeline for the startup of a biospecimen repository. List the major milestones that need to be in place before the first biospecimen case is “enrolled” into the Biorepository. (10 points).
7. MCB is one of few biobanks that offer a return of incidental research results to participants. Make a flowchart when and after what precautions the results could be used for clinical decision making and therapy? (20 points)
8. List equipment and biospecimen-tracking software for the project. Does automation contribute to the quality of the biospecimen? (10 points).
9. Describe the lifecycle of the biospecimen(s) starting with inclusion/exclusion criteria of the donor, how a biospecimen was collected, labeled, processed, stored and quality assessed.
Further describe how it was accessed, retrieved, distributed and used for analyses. (10 points).
10. Questionnaires and patient demographic data were collected with the biospecimens. This information and other biospecimen information was linked to a person’s medical record. Describe the lifecycle of the data collected together with the biospecimens. (10 points).
11. Describe the process of access to biospecimens and data? Could outside researchers use the MCB database? What documents and oversight approvals were needed for the request of biospecimen or data use? (10 points).
12. What do you think makes the MCB sustainable? (10 points)
APA formatting is required for this assignment. Carefully read the questions above and provide your answers in full sentences, with at least one or two paragraphs for each question.
Your paper should have a Title page, Introductory Paragraph, Twelve headings Level 2, Conclusion (heading Level1) and References. All text including Title page, the body of text and References should be in font Times New Roman, size 12; line spacing should be double-spaced and the paper should be well organized. Figures and Tables should be annotated as per the APA 7th edition formatting guidance, found at the Purdue Online Writing Lab (n.d.). General Writing FAQs. Retrieved June 2021 from https://owl.purdue.edu/owl/research_and_citation/apa_style/apa_formatting_and_style_guide/general_format.html

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