HCR 593 Module 3 Applied Project Bibliography Example

Course	HCR 593 Applied Project
Module	Module 3
Paper type	Annotated bibliography
Length	About 492 words, 4 pages
Format	APA 7 student paper
School	Arizona State University
Program	MS in Clinical Research Management
Updated	October 2026

Free sample paper for HCR 593 Module 3

Annotated Bibliography: Results Reporting on ClinicalTrials.gov

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 type and the project topic.

Annotated Bibliography: Results Reporting on ClinicalTrials.gov

Introduction

These five sources were chosen because together they define the legal requirement the project measures, provide earlier benchmarks against which new results can be compared and explain why timely reporting matters.

Annotations

1. Reporting From 2008 to 2012

Summary: Using an algorithm to identify trials highly likely to be covered by the law, the authors examined 13,327 trials completed or terminated from 2008 through August 2012; just 13.4% posted results inside a year and 38.3% by September 2013, with industry funding and FDA oversight associated with more timely reporting (Anderson et al., 2015). Evaluation: A large, careful study, though it preceded the final rule and relied on an algorithm to judge which trials were covered. Role in the project: an early benchmark that shows how much reporting has changed.

2. The Final Rule

Summary: Written by ClinicalTrials.gov leaders, this article explains the 2016 final rule implementing the 2007 law: which trials must register and report, the one-year deadline for results, the data elements required and the expansion of reporting to unapproved products (Zarin et al., 2016). Evaluation: An authoritative explanation from the agency, not an independent assessment. Role in the project: it defines the requirement the project's main outcome measures.

3. Compliance Under the Final Rule

Summary: Of the 4,209 trials whose deadline had passed by September 2019, about two in five (40.9%) met it and fewer than two-thirds (63.8%) had submitted at all; industry sponsors were more likely than other non-government sponsors to comply, and the median delay was 424 days (DeVito et al., 2020). Evaluation: The most rigorous compliance study to date, excluding trials with certificates for delayed reporting. Role in the project: the closest benchmark, and its method shows what this project cannot do with registry fields alone.

4. Publication of NIH-Funded Trials

Summary: Fewer than half of 635 NIH-funded trials completed by 2008 reached a journal within 30 months (46%), and about two-thirds (68%) ever did (Ross et al., 2012). Evaluation: A focused study of publication rather than registry reporting, limited to NIH funding. Role in the project: it shows why registry results matter, since many trials are never published in journals.

5. The Regulation

Summary: The rule makes results due, in general, within twelve months of primary completion, with exceptions for certifications that delay submission (42 C.F.R. § 11.44). Evaluation: The primary legal source. Role in the project: it defines the 365-day threshold and explains why the project's measure is a proxy, since certifications are not visible in the extracted fields.

What this page is doingGiving each annotation a stated role in the project shows the instructor why each source earns a place among only five.

Synthesis

The sources show a requirement that has existed since 2007 but was poorly met before the final rule and only partly met after it, with industry consistently more timely than other sponsors. They also show that registry results matter because journal publication is incomplete. The project will measure whether trials completing in 2021 and 2022 do better than the 40.9% found for trials due in 2018 and 2019.

References

Anderson, M. L., Chiswell, K., Peterson, E. D., Tasneem, A., Topping, J., & Califf, R. M. (2015). Compliance with results reporting at ClinicalTrials.gov. New England Journal of Medicine, 372(11), 1031-1039. https://doi.org/10.1056/NEJMsa1409364

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

Ross, J. S., Tse, T., Zarin, D. A., Xu, H., Zhou, L., & Krumholz, H. M. (2012). Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ, 344, d7292. https://doi.org/10.1136/bmj.d7292

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

Reading the HCR 593 Module 3 assignment instructions

The Annotated Bibliography is due in Module 3 of HCR 593 and is worth 50 points. The syllabus asks you to submit annotations for five of the most important sources supporting the goals of your applied project, in a module that also covers how a background and introduction support a project and the informed consent requirements of any planned research. Five is a small number, so each source must earn its place: choose those that define your main concepts or requirements, provide benchmarks you will compare against, establish why the problem matters or supply your methods. For every source, say what it found, how much weight it bears and exactly where your project will use it. The same sources will anchor the Introduction and Background due in Module 5, so annotate with that paper in mind.

How the HCR 593 Module 3 example is put together

A two-sentence introduction explains why these five sources were chosen. Each annotation has a descriptive heading and three labeled parts: summary with key numbers, evaluation of strength and limits and the source's role in the project. The sources cover a historical benchmark, the rule that defines the requirement, the most recent compliance study, the reason registry results matter and the regulation itself. A margin note explains why each annotation names its role. A synthesis paragraph states what the sources show together and the comparison the project will make. Each annotation is roughly the same length, so no source dominates the bibliography, and every summary includes the number the project will compare against.

Where the marks sit in the HCR 593 Module 3 rubric

This bibliography earns up to 50 points when it picks the five sources most important to the project, summarizes each accurately with key findings, evaluates strength honestly, explains each source's role in the project and uses correct APA style. It loses ground when sources are peripheral, when annotations only summarize, when findings are misreported and when the number of sources does not match the requirement. Readers value annotations that anticipate how sources will be used in the background and discussion, since the bibliography is a working tool for the rest of the project. A short synthesis that names the project's comparison often earns extra credit.

HCR 593 Module 3 help with common mistakes

List candidate sources, then keep only the five that do the most work for your questions. Give each annotation the same three parts. Record exact numbers and sample sizes. Name the role each source plays: definition, benchmark, rationale or method. Include the primary legal or regulatory source if your topic has one. Add a short synthesis. If you are deciding between two sources, the desk can help you judge which supports your project better. Keep a note of where each source will appear in your later papers. Recheck numbers against the original article before you submit.

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.

More HCR 593 and MS in Clinical Research Management sample papers

HCR 593 Module 3 questions, answered

Where can I find a free HCR 593 Module 3 sample paper?

The complete applied project annotated bibliography on results reporting at ClinicalTrials.gov is on this page.

How many sources does the HCR 593 annotated bibliography need?

Five of the most important sources supporting the applied project's goals.

What should each annotation include?

A summary with key findings, an evaluation of the source's strength and its specific role in the project.

How timely was results reporting under the final rule?

A study of trials due by 2019 found 40.9% submitted results within one year of primary completion.

What is due after the HCR 593 bibliography?

A progress report and the introduction and background, a review of at least five pages, in Module 5.

HCR 593 Module 3 Annotated Bibliography for the Applied Project Example