| Course | HCR 566 Clinical Research Management Capstone |
|---|---|
| Module | Module 2 |
| Paper type | Research proposal |
| Length | About 577 words, 5 pages |
| Format | APA 7 student paper |
| School | Arizona State University |
| Program | MS in Clinical Research Management |
| Updated | October 2026 |
Free sample paper for HCR 566 Module 2
Capstone Proposal: Upper Age Limits in Phase 3 Heart Failure Trials Registered From 2015 to 2024
Student Name
MS in Clinical Research Management, Arizona State University
HCR 566: Clinical Research Management Capstone
Instructor Name
Month Day, Year
Capstone Proposal: Upper Age Limits in Phase 3 Heart Failure Trials Registered From 2015 to 2024
Why: Background and Problem
Heart failure is a disease of older age; in U.S. epidemiologic studies, patients with heart failure average around 69 to 73 years of age, yet participants in large heart failure trials published from 2001 to 2016 averaged 65 (Tahhan et al., 2018). One mechanism is the arbitrary upper age limit, a fixed maximum age written into eligibility criteria. A 2008 snapshot of ongoing heart failure trials found that a quarter excluded patients by such a limit (Cherubini et al., 2011). Since then, the FDA has urged sponsors to broaden eligibility criteria (U.S. Food and Drug Administration, 2020). No one has yet measured whether these ceilings have become rarer in trials launched since.
What: Research Questions and Aims
Primary question: Among Phase 3 interventional heart failure trials registered on ClinicalTrials.gov with a start date from 2015 through 2024, what proportion set an upper age limit of 85 years or younger?
Secondary questions: Does the proportion differ by lead sponsor class (industry versus other) and by start period (2015 to 2019 versus 2020 to 2024)? What share of total planned or actual enrollment is in trials with such limits?
| PICOT element | This project |
|---|---|
| Population | Phase 3 interventional heart failure trials registered on ClinicalTrials.gov |
| Intervention or exposure | Presence of an upper age limit of 85 years or younger |
| Comparison | Industry versus non-industry sponsors; 2015 to 2019 versus 2020 to 2024 |
| Outcome | Proportion of trials with an upper age limit; share of enrollment |
| Time | Trials with start dates from January 2015 to December 2024 |
Where: Data Source and Setting
ClinicalTrials.gov, the public U.S. registry of clinical studies, accessed through its application programming interface. No human participants are involved; the project uses publicly available registry data, so IRB review is not required, though the student will confirm this with the course faculty.
How: Design and Methods
Design: cross-sectional analysis of registry records. Search: condition "heart failure," study type interventional, phase 3, start date 2015-01-01 to 2024-12-31. Inclusion: the trial's condition list names heart failure or cardiac failure, and the trial is not limited to children. Variables: maximum and minimum eligible age, start date, lead sponsor class, enrollment count and status. Definitions: an upper age limit is a listed maximum age of 85 years or younger; listed maximums above 85, such as 99 or 130, are treated as placeholders rather than real limits. Analysis: proportions with 95% confidence intervals; comparisons by sponsor class and period using chi-square tests; enrollment shares. A random sample of 20 records will be checked against the full registry entries to confirm that the extracted fields are accurate.
Resources
A laptop, a free scripting tool for the registry download, a spreadsheet program for analysis and the course's templates. No funding is required.
When: Timeline
| Week | Milestone |
|---|---|
| 2 | Proposal and timeline submitted |
| 3-4 | Data download, cleaning and validation sample |
| 5 | Draft literature review |
| 6-7 | Analysis and first progress report |
| 8 | Capstone draft 1 |
| 9-10 | Revision; draft 2 |
| 11 | Final capstone paper |
| 13 | Scientific poster |
Limitations Anticipated
Registry fields depend on sponsor entry and may be incomplete. Upper age limits are only one way older adults are excluded; indirect criteria, such as kidney function thresholds, are outside this project's scope.
Expected Contribution
The project will update a 2008 benchmark with recent data and give sponsors, investigators and IRBs a measurable picture of an eligibility practice regulators have asked them to reconsider.
References
Cherubini, A., Oristrell, J., Pla, X., Ruggiero, C., Ferretti, R., Diestre, G., Clarfield, A. M., Crome, P., Hertogh, C., Lesauskaite, V., Prada, G.-I., Szczerbinska, K., Topinkova, E., Sinclair-Cohen, J., Edbrooke, D., & Mills, G. H. (2011). The persistent exclusion of older patients from ongoing clinical trials regarding heart failure. Archives of Internal Medicine, 171(6), 550-556. https://doi.org/10.1001/archinternmed.2011.31
Tahhan, A. S., Vaduganathan, M., Greene, S. J., Fonarow, G. C., Fiuzat, M., Jessup, M., Lindenfeld, J., O'Connor, C. M., & Butler, J. (2018). Enrollment of older patients, women, and racial and ethnic minorities in contemporary heart failure clinical trials: A systematic review. JAMA Cardiology, 3(10), 1011-1019. https://doi.org/10.1001/jamacardio.2018.2559
U.S. Food and Drug Administration. (2020). Enhancing the diversity of clinical trial populations: Eligibility criteria, enrollment practices, and trial designs [Guidance for industry]. https://www.fda.gov/media/127712/download
Reading the HCR 566 Module 2 assignment instructions
The Capstone Proposal is due in Module 2 of HCR 566 with a project timeline, worth 50 and 10 points. In the syllabus's words it is a short paper presenting the capstone as a complete research plan with its resources, and Module 2 frames it around the where, why, what, how and when. The course requires its own proposal and timeline templates, so follow their headings. Module 2's readings on PICOT and getting started point to framing the question precisely. Choose a project you can complete within the semester with the access you have; registry analyses, document reviews, quality improvement evaluations and surveys of professionals are common choices in clinical research management. The proposal sets up everything that follows: the literature review in Module 5, progress reports, two drafts, the final paper and the poster.
How this HCR 566 Module 2 example is built
The sample follows the five questions the module names. The why section summarizes the problem with two studies and a regulatory guidance. The what section states a primary and two secondary questions and recasts them in a PICOT table. The where section names the data source and addresses whether IRB review is needed. The how section gives design, search terms, variables, definitions, analysis and a data accuracy check. Resources are listed briefly, the timeline appears as a table by week and the proposal closes with anticipated limitations and the expected contribution. The definitions in the methods section, such as what counts as an upper age limit, are written so another student could repeat the study exactly.
HCR 566 Module 2 rubric: what earns full marks
The proposal earns up to 50 points and the timeline 10 on their Canvas rubrics. Credit goes to a feasible project with a clear problem grounded in literature, specific research questions, methods detailed enough that someone else could carry them out, honest attention to ethics and approvals, realistic resources and a timeline that fits the semester. Deductions follow an oversized topic, questions the proposed data cannot answer, when methods are vague, when the IRB question is ignored and when the template is not used. Instructors look ahead when grading: a proposal that already defines variables and analysis makes the rest of the capstone far easier, and readers notice that preparation.
HCR 566 Module 2 help with common mistakes
Pick a project you can finish in one semester with data you can actually access. Write the research question first and test it against PICOT. Define every key term, such as what counts as an upper age limit. Say how you will check data accuracy. Address IRB review even if you think it is not needed. Build the timeline backward from the final paper and poster dates. Use the required template. Two topics in mind? The desk can compare their feasibility. Ask yourself whether the project could fail for lack of data and plan an alternative if so. Keep the proposal on the template's headings so faculty can find each part quickly.
Write yours, or have the desk draft it
This paper is an original model document written by our desk, not a submitted student paper and not an official Arizona State University document. Read it for the moves, then write your own to the instructions in your classroom. If you want one built to your exact prompt and rubric, the first custom sample is free and arrives in 24 to 48 hours.
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HCR 566 Module 2 questions, answered
Where can I find a free HCR 566 Module 2 sample paper?
This page has a full HCR 566 capstone proposal for a registry study of upper age limits in Phase 3 heart failure trials.
What goes into the HCR 566 capstone proposal?
The where, why, what, how and when of the project, its resources and a timeline, on the course template.
Can a capstone use public registry data?
Yes. Registry analyses are feasible capstones and usually do not need IRB review, which should be confirmed with faculty.
How do I make a capstone question specific?
Frame it with PICOT and define each key term so the data can answer it.
How many points is the HCR 566 proposal worth?
50 points, plus 10 for the project timeline.