HCR 593 Module 1 Applied Project Proposal Example

Reviewed by Emmett Rockwell, MBA Arizona State University Updated October 2026

This HCR 593 Module 1 sample is the Applied Project Proposal in the Applied Project course, the culminating course of ASU's MS in Clinical Research Management and its sister regulatory science degree. Worth 50 points and due in the first module, the proposal in ASU HCR 593 asks students to present a fully designed plan for their applied project, with research questions, methods and resources. The composite student proposes measuring, from registry records, the speed of results submission for completed late-phase drug trials run at U.S. sites that reached primary completion in 2021 or 2022. It asks what share submitted within the one-year federal deadline, whether industry and other sponsors differ and how current performance compares with earlier studies.

CourseHCR 593 Applied Project
ModuleModule 1
Paper typeResearch proposal
LengthAbout 471 words, 4 pages
FormatAPA 7 student paper
SchoolArizona State University
ProgramMS in Clinical Research Management
UpdatedOctober 2026

Free sample paper for HCR 593 Module 1

1

Applied Project Proposal: Timeliness of Results Submission for Phase 3 and 4 Drug Trials Completed in 2021 and 2022

Student Name

MS in Clinical Research Management, Arizona State University

HCR 593: Applied Project

Instructor Name

Month Day, Year

What this page is doingThe title names the document, the outcome measured and the trials studied.
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Applied Project Proposal: Timeliness of Results Submission for Phase 3 and 4 Drug Trials Completed in 2021 and 2022

Background and Rationale

Under the Food and Drug Administration Amendments Act of 2007 and its final rule, sponsors of applicable clinical trials must submit summary results to ClinicalTrials.gov, generally within one year of the primary completion date (Zarin et al., 2016), a deadline written into the regulation (42 C.F.R. § 11.44). Unreported results distort the evidence base and break the promise made to participants. A study of trials due to report by September 2019 found that only 40.9% submitted on time (DeVito et al., 2020). Since then, the FDA has begun issuing notices of noncompliance, and sponsors have had several more years to build reporting processes. Whether timeliness has improved for recent trials is the question this project addresses.

Research Questions

1. Among completed Phase 3 and 4 interventional drug trials with U.S. sites and primary completion dates in 2021 or 2022, what proportion submitted results to ClinicalTrials.gov within 365 days of primary completion?

2. What proportion submitted results at any time by October 2026?

3. Do these proportions differ between industry and other lead sponsors, and between trials completing in 2021 and 2022?

What this page is doingWriting three numbered questions, each answerable from registry fields, shows the reader the study is feasible before the methods are described.
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Methods

Design: cross-sectional analysis of public registry data. Data source: the ClinicalTrials.gov application programming interface. Inclusion: interventional studies; Phase 3 or Phase 4; overall status completed; primary completion date from January 1, 2021, to December 31, 2022; at least one U.S. location; at least one drug intervention. Variables: primary completion date, date results were first submitted, date results were first posted, lead sponsor class and whether the trial studies an FDA-regulated drug. Outcomes: submission within 365 days; any submission. Analysis: proportions with 95% confidence intervals; chi-square comparisons by sponsor class and completion year; median days from primary completion to submission.

Ethics

The project uses only public registry data about trials, not individuals, so it does not meet the definition of human subjects research; the student will confirm with faculty and document that IRB review is not needed.

Resources and Timeline

A laptop, a free scripting tool to download records, a spreadsheet for analysis and the course templates. The timeline follows the course: proposal and timeline in Modules 1 and 2, annotated bibliography in Module 3, introduction and background in Module 5, drafts in Modules 7 and 9, final paper in Module 12 and a scientific poster in Module 13.

Anticipated Limitations

The registry does not show which trials hold certificates allowing delayed submission or which are exempt as non-applicable, so the measure is a proxy for legal compliance rather than a legal judgment. Sponsor class is broad.

Expected Contribution

The project will give a current, reproducible measure of results timeliness for late-phase drug trials, useful to sponsors' disclosure teams and to anyone tracking the effect of FDA enforcement.

References

Clinical trials registration and results information submission, 42 C.F.R. § 11.44 (2025).

DeVito, N. J., Bacon, S., & Goldacre, B. (2020). Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: A cohort study. The Lancet, 395(10221), 361-369. https://doi.org/10.1016/S0140-6736(19)33220-9

Zarin, D. A., Tse, T., Williams, R. J., & Carr, S. (2016). Trial reporting in ClinicalTrials.gov: The final rule. New England Journal of Medicine, 375(20), 1998-2004. https://doi.org/10.1056/NEJMsr1611785

What the HCR 593 Module 1 instructions ask for

HCR 593 begins with the Applied Project Proposal in Module 1, worth 50 points, followed in Module 2 by a timeline. The syllabus wants a short paper that sets out the whole plan for your applied project and what it will need, and Module 1 is where your research questions take shape. That means the proposal should already read like the opening of a study: a problem grounded in literature, numbered research questions, a design and data source, defined variables and outcomes, an analysis plan, an ethics determination, resources and expected limitations. Choose a project you can complete in one semester; registry analyses, document reviews, process evaluations and surveys of professionals work well. Everything later in the course, the annotated bibliography, introduction and background, drafts, final paper and poster, builds on this plan.

How this HCR 593 Module 1 example is built

The proposal opens with the legal requirement behind the topic, cites the regulation's summary and the most recent compliance study and states the question. Three numbered research questions follow. Design, source, inclusion rules, variables, outcomes and analysis are all spelled out, enough for a classmate to rerun the work. A short ethics section explains why IRB review is not needed and how that will be confirmed. Resources and the timeline are brief, and two closing sections name the expected limits and what the study will add. The inclusion rules are listed exactly as they will be applied, and the outcomes are defined in days, so the study can be repeated by anyone with the same registry access.

Where the marks sit in the HCR 593 Module 1 rubric

Fifty points are at stake in the proposal. Strong proposals offer a doable project, a problem rooted in recent literature, specific and answerable research questions, methods detailed enough to reproduce, appropriate attention to ethics, realistic resources and honest limitations. Points are lost when questions are vague, when the data source cannot answer them, when variables and outcomes are not defined and when the IRB question is skipped. Faculty also check scope: a proposal that tries to do too much in one semester is marked down as surely as one with no plan. A proposal that already anticipates its limitations reads as more credible.

HCR 593 Module 1 help: mistakes that cost marks

Write your research questions first and check that each can be answered with data you can get. Define every outcome precisely, for example what counts as on time. List inclusion rules exactly. Say how you will analyze each question. Address ethics even for public data. Note limitations now so they do not surprise you later. Keep the scope to one semester. If you are unsure whether your data source can answer your questions, the desk can check before you submit. Run a small test download before you submit the proposal to make sure your fields exist and contain what you expect.

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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More HCR 593 and MS in Clinical Research Management sample papers

HCR 593 Module 1 questions, answered

Where can I find a free HCR 593 Module 1 sample paper?

This page has a full HCR 593 applied project proposal on results-submission timeliness for late-phase drug trials.

What does the HCR 593 proposal include?

The problem, research questions, design, data source, variables, analysis, ethics, resources and limitations of the applied project.

When are clinical trial results due on ClinicalTrials.gov?

Generally within one year of the primary completion date for applicable clinical trials, unless a certification delays the deadline.

Does a registry study need IRB review?

Usually not, since it involves no human subjects, but students should confirm with faculty and document the decision.

What comes after the HCR 593 proposal?

A timeline, an annotated bibliography, an introduction and background, drafts, the final paper and a scientific poster.