Module #1 CTC Assignments- HCR577

Module #1 CTC Assignments- HCR577

Module 1: Overview of Common Technical Document (CTD) Assignments
CTD Module Preparation
In this class, you are preparing a submission for the FDA. You know that the FDA requires the submission in the Common Technical Document (CTD) format.  This format is new to your company.  You want to ensure that management has time to review and approve each section to prevent delays due to the need to address feedback and comments.
You will use ADA formatting for your CTD.  Each Section must be completed with information received in class or by researching your assigned drug.Refer to the classroom materials and online guidelines and guidance for CTD formatting.
  • During Module 1/Week 1, you will identify the drug for this CTD drug in the discussion.
  • During Modules/Weeks 2,3,4 & 5, you will use your assigned drug to complete each of the Modules.
  • For Module 4 & 5, research types of studies that may be performed during clinical studies.  List at least 3-5 studies for these sections.
  • In Module 6, finally you will assemble the CTD into a single document.  Then, preparing for submission, you will prepare a 1 page cover letter to the health authority and add this to the CTD and submit to complete the assignment.

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CTD in the Course Schedule

 

Week
Topics/Lessons/Course Outcomes
Activities
Assignments
Mod 1  Week 1
Global Regulatory Affairs Overview – regulatory authorities, regulations, stakeholder roles & responsibilities (Outcomes 1, 3 & 7)
Discussion (choose drug)
Mod 2 Week 2
Regulatory Framework, CTD – Module 2: Quality Summary (Outcomes 2, 3, 4, 5)
Discussion: Medical Product Development Process in US
Mod 3 Week 3
CTD – Module : Quality (Outcomes 2, 3, 4 & 5)
Discussion: Quality Control Tests
Mod 4 Week 4
CTD – Modules 4: Nonclinical/technical requirements & 5: Clinical Studies & Reports; Benefit-Risk Information (Outcomes 2, 3, 4, 5, 6 & 7)
Midterm
Mod 5 Week 5
CTD Submission Process – US & EU (Outcomes 4 & 5)
Discussion Board 4 – Risk/Benefit
Group PowerPoint & Summary
Mod 6 Week 6
Regulatory Overview: Asia, Canada & Emerging Countries (Outcomes 6 & 7)
Discussion Board 5 – Biosimilars
Combine CTD modules to prepare for submission with cover letter to the health authority
Mod 7 Week 7
Global Trends, Ethical and Cultural Concerns, and Issues (Outcomes 1, 3 & 6)
Paper – Current Trends and Issues in the conduct of global clinical trials
Course Reflection
Mod 7 Week 8
Final Exam (Outcomes 1 – 7)
Final

Discussion Post #1- HCR 577

Discussion Post #1- HCR 577

Due Mar 22 11:59pm
Available from Mar 16 until Mar 23
40 points possible
3 Replies, 3 Unread
3 Replies, 3 Unread
Discussion Topic: Module 1: Discussion Post Module 1: Discussion Post
Instructions
For your initial post to the discussion, please do the following:
Prepare a paragraph, 4 – 5 sentences introducing yourself to the class.  Please share your major at ASU, any industry experience, and a skill you would like to have.
Propose a drug that you would like to use for your CTD.  Each student must have a different drug. In this course you will be creating a Common Technical Document (CTD).
Describe the scope and mission of regulatory authorities based upon the article (cite 3 agencies), regulations (cite 3 examples), and the roles and responsibilities of pharmaceutical industry stakeholders (identify 3).  Initial post is due on Wednesday by 11:59 p.m.
Peer Responses
Respond to posts by two of your peers with additional ideas, questions, or thoughts. There is no length requirement, however responses should contribute substantially to the discussion. Make sure they are engaging by asking questions, challenging each other in a professional manner, and providing new information for others to review and think about. You are expected to communicate respectfully and practice good netiquette in all course interactions. Peer responses will be due on Sunday by 11:59 p.m.
Grading
Initial posts are worth up to a total of 20 points, and peer responses are worth up to an additional 20 points. See the grading rubric for a better understanding of how to get your best grade.  To access the rubric, click on the three vertical lines at the top of the page and select “show rubric.”
View the discussion rubric
Click on Reply to post to the discussion.
Module 1 Discussion Rubric
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeInitial Post
20 ptsExcellent The post is comprehensive and fully answers the discussion prompt. Student used complete sentences, appropriate tone, and clear language.
10 ptsGoodThe post is comprehensive, but does not fully answer the discussion prompt. Student used complete sentences, appropriate tone, and mostly clear language.
0 ptsNeeds Significant Improvement The posting is not comprehensive and does not answer the discussion prompt. Student used Incomplete sentences, inappropriate tone, and/or unclear language.
20 pts
This criterion is linked to a Learning OutcomeReply Post
20 ptsExcellent Student posted at least 1 reply to another student that was relevant to the discussion.
10 ptsGoodStudent posted one reply to another student, but it was not relevant or did not significantly contribute to the discussion.
0 ptsNeeds Significant Improvement Student did not post a reply, or reply contained incomplete sentences, inappropriate tone, and/ or unclear language.

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SOWK 602: One Crazy Summer

SOWK 602: One Crazy Summer

“One Crazy Summer” (Garcia-Williams, 2010) is a short novel written with teens and young adults in mind.  This novel tells the story of three preteen sisters who travel from Brooklyn to Oakland in 1968, at the height of the Black Power Movement, to reunite with their mother, who has allegedly abandoned them. Throughout the story there is tension and symbolic representation around “nommo,” including the mother’s refusal to speak her youngest daughter’s “given” name, since this was not the name she gave to her daughter. Additional incidents around self-definition arise as there is a confrontation around the terms “colored girl” or “Black.” The book serves as a case study for understanding family in the context of environment and self in the context of family and community.
The Critical Race Assignment requires students to connect the course readings, book context, and research and historical documents.  You will utilize this context to
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1) Talk about your self-described racial identity, using Cross’ (1978) “Five Stages of African American Identity” and Boyd-Franklin’s (2003) Black Families in Therapy: Understanding the African American Experience.

2) Interview a member of your family or community to provide additional first-hand insight about the community climate of the Civil Rights and Black Power Movement.  What do they remember about the political climate at the national and/or local community level during this time period? How did the social policies, customs, or traditions impact their aspirations and interpretation of the family in the community?  In other words, what critical racial tenets impacted the functioning of families?

3) Examine gender roles and identity, as well as race and power dynamics. Discuss the social issues around employment, education, economics, politics, and the incidents of community unrest.

The paper is submitted in APA format with appropriate references.  The paper should be between 3 pages.

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SOWK 602: Social Pioneer

SOWK 602: Social Pioneer

This discussion examines African American leadership as an empowerment tradition within the history of social welfare. Drawing on Carlton-LaNey’s work, students will explore how leadership, resistance, and community organizing by African Americans have shaped social work values, practice approaches, and advocacy efforts—particularly within marginalized and urban communities.

Post Instructions
After completing the reading, respond to all four (4) questions below in a single, cohesive post.

Your initial post should:

Demonstrate clear engagement with Carlton-LaNey’s text

Incorporate specific concepts, examples, or language from the reading

Reflect critical thinking and application to contemporary social work practice

Be written in a professional, scholarly tone

Discussion Questions
Leadership as an Empowerment Tradition
According to Carlton-LaNey, how has African American leadership historically functioned as an empowerment tradition within social welfare? What distinguishes this leadership tradition from dominant or Eurocentric models of leadership?

Challenging Dominant Narratives
Carlton-LaNey highlights the marginalization of African American leaders in traditional social welfare histories. Why is it important for social workers to critically examine whose leadership is recognized and whose is omitted? How does this omission shape contemporary practice, policy, or education?

Connections to Social Work Values and Ethics
How do the leadership traditions described by Carlton-LaNey align with core social work values such as social justice, dignity and worth of the person, self-determination, and advocacy? Provide at least one example from the reading.

Application to Contemporary Practice
Identify a current social work context (e.g., community organizing, child welfare, education, mental health, policy advocacy, urban practice).

How can African American leadership traditions inform empowerment-based practice in this context today?

What responsibilities do social workers have to recognize, support, and collaborate with community-based leaders?

After posting your initial response, you are required to respond to at least one (1) classmates.

Peer responses should:

Reference a specific point made by your classmate

Extend the discussion by connecting to Carlton-LaNey’s arguments or concepts

Ask a thoughtful question or offer an additional perspective

Maintain respect and professional tone

Responses that simply state agreement (e.g., “I agree”) without elaboration will not receive full credit.

General Discussion Board Rubric
1. Engagement with Assigned Readings (4 points)
4 points: Clearly demonstrates engagement with assigned readings or materials; accurately integrates key concepts, language, or examples.

3 points: Demonstrates engagement with readings, though integration may be limited or surface-level.

2 points: Minimal reference to readings; limited evidence of preparation.

1–0 points: Little to no evidence that readings were completed or used.

2. Understanding of Course Concepts (4 points)
4 points: Demonstrates clear, accurate understanding of key course concepts and themes.

3 points: Demonstrates general understanding with minor inaccuracies or gaps.

2 points: Partial or unclear understanding of concepts.

1–0 points: Demonstrates limited or inaccurate understanding.

3. Critical Thinking and Reflection (4 points)
4 points: Provides thoughtful analysis, reflection, and synthesis; moves beyond summary or description.

3 points: Some analysis is present, though reflection may lack depth.

2 points: Primarily descriptive with limited critical thinking.

1–0 points: Little to no analysis or reflection.

4. Application to Social Work Practice (4 p…
[18:08, 04/03/2026] Topscholarshelp.com: Overview

In this module will discuss African American Pioneers of social work with Black Families.

The learning outcomes for this module are:

1. Students will be able to identify 3 areas of concern for African American Social Welfare Pioneers.

2. Students will be to identify 3 values of African American Social Welfare Pioneers.

3. Students will be able to identify 6 contributions of African American Social Welfare Pioneers to the African American Community.

To-Do List

In order to successfully complete Module 3, please do the following:

Read: African American pioneers’ response to need by Carlton La Ney 21 – 35
Read: Garcia – Williams pgs. 75 – 116
Watch: Talk on DCN: A’Lelia Bundles
Assignment: Social pioneer paper

Recommended Reading:

Carlton-LaNey, I.B. (2001). African American Leadership: An Empowerment Tradition in Social Welfare History. Washington, DC: NASW Press.

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HCR 593: Module 6: Overview

HCR 593: Module 6: Overview

Overview

In this module, you will be reflecting on your progress in developing your applied project by focusing on a project update.

Learning Objectives

By the end of this module, students will be able to:

  1. Provide a clear depiction of the progress being made based on the proposal and timeline.
  2. Examine research and research writing barriers you have encountered versus your expectation upon initiating this journey.
  3. To Do
  4. Do review all feedback on your background (and introduction) submission and apply corrections and improvements that are in track changes (for DRAFT submission or resubmission if required – Instructors will guide you).
  5. Submit Discussion Board posts that focus on research barriers you have encountered thus far in your research with the applied project.
    1. Discussion Board Primary post due Wednesday, 11:59 PM.
    2. Discussion Board three (3) peer posts are due Saturday, 11:59 PM.
  6. Submit a Progress Report by Sunday, 11:59 PM
  7. Looking forward: Prepare to submit the First Draft of the Applied Project in Module 7, 
    1. This submission must include corrections and improvements from the Module 5 submission (clearly evident – track changes and comment bubbles are the best strategies).
    2. This submission must be formatted using the provided template.
    3. The Methods chapter must be completed in this draft as well.
Module 6: Discussion Board 3 – Barriers
Assignment
Mar 7 by 11:59pm
Discussion Board 3: 
A well-designed study will clearly identify an exposure/risk and an outcome in an objective, quantifiable manner to answer a defined hypothesis/research question.
  • What barriers or challenges have you encountered?
  • How did you handle them?
  • Did you need to change/revise your project design?
Responses Due by:
Initial Response: Wednesday 11:59 PM (20 pts)
Peer Responses (at least 3): Saturday 11:59PM (30 pts)
Gentle reminder that DBs are not accepted late.

HCR 593- Listeria FSIS Directive

HCR 593- Listeria FSIS Directive

The U.S. Department of Agriculture’s Food Safety and Inspection Service is announcing several new steps to strengthen the agency’s oversight of meat, poultry and egg processing facilities it regulates.
Over the past several months, Listeria monocytogenes has been linked to foodborne illness outbreaks and large-scale recalls of ready-to-eat meat and poultry products, causing FSIS to review its processes. While the agency’s review continues, FSIS is announcing a number of improvements and initiatives that can be implemented quickly. The agency will share more information about additional actions that may be needed after further review and stakeholder engagement.
“As a science-based regulatory agency, USDA’s Food Safety and Inspection Service is constantly looking at ways we can and should evolve our processes to protect the public, maintain confidence in America’s food supply, and prevent foodborne illness,” said Dr. Emilio Esteban, USDA under secretary for food safety. “These steps are common sense improvements to our work that will strengthen our food safety net as we continue improving the agency’s work to align with the best available science and practices.”
The changes FSIS is announcing fall into three categories: enhancing FSIS’ science-based approach to mitigate foodborne pathogens, with a key focus on Listeria monocytogenes; improving training and tools for FSIS’ inspection workforce; and evolving FSIS oversight of regulated facilities, with an emphasis on data review and state inspection agreements
FSIS will initiate the following changes in the next 30 days:
Enhancing FSIS’ regulatory, sampling approach to Listeria
  • Effective January 2025, FSIS will add broader Listeria species testing to all samples of ready-to-eat product, environmental and food contact surfacesFSIS laboratories currently test these samples for Listeria monocytogenes, which is the specific type of Listeria species that causes illness. However, adding additional species testing to the agency’s regulatory framework will help provide more information about the effectiveness of a facility’s sanitation program and can signal to FSIS if follow up is needed (for example, a Food Safety Assessment, intensified sampling or enforcement actions).
  • FSIS will leverage the expertise of its National Advisory Committee on Microbiological Criteria for Foods. NACMCF is a federal advisory committee that provides scientific advice and recommendations to USDA and other government agencies on microbiological and public health issues. In December, FSIS will begin recruitment for new committee members, who will be given the specific charge of reviewing the agency’s regulatory approach to Listeria monocytogenes. Expertise in Listeria will be sought for membership. The committee’s input will be used to guide more long-term policy changes.
Equipping FSIS inspectors with updated training, tools
  • FSIS will update its instructions and training for food safety inspectors to better equip the workforce to recognize and highlight systemic problems in a standardized way. Agency inspectors will receive updated instructions and training, and FSIS field supervisors will routinely review these instructions with inspectors to ensure full understanding and appropriate application. Inspectors will also receive supplemental Listeria monocytogenes control training designed to help strengthen inspectors’ understanding of the regulatory requirements in FSIS’ Listeria Rule and how to verify establishments have designed and implemented food safety systems that comply with those requirements.
  • FSIS will conduct Food Safety Assessments (in-depth food safety reviews) at ready-to-eat meat and poultry facilities. In FY 2025, FSIS is prioritizing completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria. These reviews will provide information about the plants individually and collectively and could inform future policy or process changes to target this microorganism.
  • FSIS field supervisors will conduct in-person follow-up visits when systemic issues are identified during a Food Safety Assessment. Follow-up visits by FSIS field supervisors will bolster oversight from more senior inspection staff to ensure a facility fully addresses issues identified during a Food Safety Assessment and could inform enforcement action by FSIS. Field supervisors will work with inspectors to ensure the facility stays in compliance.
Tightening oversight of regulated establishments, including those under state inspection models
  • FSIS inspectors will verify specific Listeria monocytogenes-related risk factors at ready-to-eat facilities weekly. These risk factors include changes in physical plant modifications, such as new construction; indicators of sanitation problems, such as condensation, roof leaks, damaged equipment or cracked floors; and Listeria species or Listeria monocytogenes positive test results from company testing. FSIS district offices, agency field supervisors and inspectors will review, analyze and consider the weekly data from each facility to determine if there are systemic issues that warrant further action, such as a Food Safety Assessment, intensified sampling or enforcement steps.
  • FSIS will clarify state and federal requirements for consistent oversight of Talmadge-Aiken programs through updated cooperative agreements and instructions. Through updated cooperative agreements with each participating state, FSIS will set specific requirements, including clear expectations for oversight, enforcing federal food safety laws, comprehensive federal training for Talmadge-Aiken inspectors and enhanced regular coordination with FSIS. FSIS will also designate field and headquarters positions assigned to Talmadge-Aiken oversight; will clarify training requirements and criteria to start, maintain and terminate state inspection coverage of an establishment.
  • FSIS will revise establishment-review alert triggers. One significant criterion used to guide a district office’s decision to conduct a Public Health Risk Evaluation, which typically precedes a Food Safety Assessment, is a monthly list of facilities with higher rates of noncompliance related to public health that is generated using an algorithm. Using additional data from the new weekly verification of Listeria monocytogenes-related risk factors, FSIS intends to update its algorithm and triggers to better identify high-risk facilities.
These actions are intended to strengthen FSIS’ inspection and oversight by enhancing its ability to proactively identify and respond to the types of systemic problems that could lead to outbreaks. Listeria monocytogenes is a pathogen of particular concern because it can be especially harmful to people with compromised immune systems, like elderly individuals and pregnant women, and it can contaminate foods that are not cooked before consumption.
FSIS is continuing to identify other steps that would improve control of Listeria monocytogenes, dependent on funding availability. As requested in the FY 2025 President’s Budget, FSIS finds additional resources are necessary for the agency to continue to meet its mission to keep meat, poultry and egg products safe and wholesome.
As the USDA’s public health regulatory agency, FSIS is responsible for ensuring the safety of meat, poultry and egg products and thereby reducing foodborne illness linked to FSIS-regulated products.
Source: USDA’s FSIS
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    • Effective January 2025, FSIS will add broader Listeria species testing to all samples of ready-to-eat product, environmental and food contact surfacesFSIS laboratories currently test these samples for Listeria monocytogenes, which is the specific type of Listeria species that causes illness. However, adding additional species testing to the agency’s regulatory framework will help provide more information about the effectiveness of a facility’s sanitation program and can signal to FSIS if follow up is needed (for example, a Food Safety Assessment, intensified sampling, or enforcement actions).
       
    • FSIS will leverage the expertise of its National Advisory Committee on Microbiological Criteria for Foods (NACMCF). NACMCF is a federal advisory committee that provides scientific advice and recommendations to USDA and other government agencies on microbiological and public health issues. In December, FSIS will begin recruitment for new committee members, who will be given the specific charge of reviewing the agency’s regulatory approach to Listeria monocytogenes. Expertise in Listeria will be sought for membership. The committee’s input will be used to guide more long-term policy changes.
    • FSIS will update its instructions and training for food safety inspectors to better equip the workforce to recognize and highlight systemic problems in a standardized way. Agency inspectors will receive updated instructions and training, and FSIS field supervisors will routinely review these instructions with inspectors to ensure full understanding and appropriate application. Inspectors will also receive supplemental Listeria monocytogenes control training designed to help strengthen inspectors’ understanding of the regulatory requirements in FSIS’ Listeria Rule and how to verify establishments have designed and implemented food safety systems that comply with those requirements.
       
    • FSIS will conduct Food Safety Assessments (in-depth food safety reviews) at ready-to-eat meat and poultry facilities. In FY 2025, FSIS is prioritizing completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria. These reviews will provide information about the plants individually and collectively and could inform future policy or process changes to target this microorganism.
       
    • FSIS field supervisors will conduct in-person, follow-up visits when systemic issues are identified during a Food Safety Assessment. Follow-up visits by FSIS field supervisors will bolster oversight from more senior inspection staff to ensure a facility fully addresses issues identified during a Food Safety Assessment and could inform enforcement action by FSIS. Field supervisors will work with inspectors to ensure the facility stays in compliance.
    • FSIS inspectors will verify specific Listeria monocytogenes-related risk factors at ready-to-eat facilities weekly. These risk factors include changes in physical plant modifications, such as new construction; indicators of sanitation problems, such as condensation, roof leaks, damaged equipment, or cracked floors; and Listeria species or Listeria monocytogenes positive test results from company testing. FSIS district offices, agency field supervisors and inspectors will review, analyze and consider the weekly data from each facility to determine if there are systemic issues that warrant further action, such as a Food Safety Assessment, intensified sampling, or enforcement steps.
       
    • FSIS will clarify state and Federal requirements for consistent oversight of Talmadge-Aiken (TA) programs through updated cooperative agreements and instructions. Through updated cooperative agreements with each participating state, FSIS will set specific requirements, including clear expectations for oversight, enforcing federal food safety laws, comprehensive federal training for TA inspectors, and enhanced regular coordination with FSIS. FSIS will also designate field and headquarters positions assigned to TA oversight; will clarify training requirements and criteria to start, maintain and terminate state inspection coverage of an establishment.
       
    • FSIS will revise establishment-review alert triggers. One significant criterion used to guide a district office’s decision to conduct a Public Health Risk Evaluation (PHRE), which typically precedes a Food Safety Assessment, is a monthly list of facilities with higher rates of noncompliance related to public health that is generated using an algorithm. Using additional data from the new weekly verification of Listeria monocytogenes-related risk factors, FSIS intends to update its algorithm and triggers to better identify high-risk facilities.
  • JJS Adult Pekin duck
    Despite continued economic pressures, the poultry…
    FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes
    Woman looking at food labeling in refrigerated section in grocery store
    Edited February 2025
    WASHINGTON, December 17, 2024 – The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) today announced several new steps to strengthen the agency’s oversight of food processing facilities it regulates (meat, poultry and egg products) and ensure safe food. These steps reflect the agency’s continual effort to protect public health through science-based regulation, strong enforcement, and advancement of its prevention-first approach to eliminating foodborne illness.
    Over the past several months, Listeria monocytogenes has been linked to foodborne illness outbreaks and large-scale recalls of ready-to-eat meat and poultry products, causing the agency to review its processes closely. While the agency’s review continues, FSIS is announcing a number of improvements and initiatives that can be implemented quickly. The agency will share more information about additional actions that may be needed after further review and stakeholder engagement.
    The changes FSIS is announcing today fall into three categories: enhancing its science-based approach to mitigate foodborne pathogens, with a key focus on Listeria monocytogenes; improving training and tools for its inspection workforce; and evolving its oversight of regulated facilities, with an emphasis on data review and state inspection agreements.
    FSIS will initiate the following changes in the next 30 days:
    Enhancing FSIS’ Regulatory and Sampling Approach to Listeria
    Equipping FSIS Inspectors with Updated Training and Tools to Recognize and Respond to Systemic Food Safety Issues
    Tightening Oversight of Regulated Establishments, Including Those Under State Inspection Models
    These actions are intended to strengthen FSIS’ inspection and oversight by enhancing its ability to proactively identify and respond to the types of systemic problems that could lead to outbreaks. Listeria monocytogenes is a pathogen of particular concern because it can be especially harmful to people with compromised immune systems, like the elderly and pregnant women, and it can contaminate foods that are not cooked before consumption.
    FSIS is continuing to identify other steps that would improve control of Listeria monocytogenes, dependent on funding availability. As requested in the FY 2025 President’s Budget, additional resources are necessary for the agency to continue to meet its mission to keep meat, poultry, and egg products safe and wholesome.
    Notably, through its Salmonella framework, USDA has proposed a comprehensive effort to reduce Salmonella illnesses associated with poultry products, which have remained stubbornly high despite consistent reductions of Salmonella in these foods.
    FSIS has also issued new guidance to provide more transparency around animal raising claims like “no antibiotics ever” and “pasture-raised.” In March 2024, USDA finalized a regulation that only permits the voluntary “Product of USA” or “Made in the USA” claim to be applied to those FSIS-regulated meat and poultry products that are derived from animals born, raised, slaughtered and processed in the United States, which better aligns with consumer understanding of what the label means.
    As USDA’s public health regulatory agency, FSIS is responsible for ensuring the safety of meat, poultry, and egg products, and thereby reducing foodborne illness linked to FSIS-regulated products. More information about FSIS’ work to keep consumers safe can be found in the agency’s 2023-2026 Strategic Plan. Learn more at www.fsis.usda.gov.
    Last Updated: Dec 17, 2024

HCR 593: Module #5

HCR 593: Module #5

Module 5: Overview (first major deliverable toward your project!)
Overview
In this module we will be learning about methodology and how it applies in the creation of a research project. We will learn the relevance of study design, setting, people, resources, sample, and ethical approvals. These topics are specifically relevant to research projects but are important for you to know in the context of compliance.
Learning Objectives
By the end of this module, students will be able to:
  1. Understand the relevance of methodology, design, sample populations, and settings as it pertains to research projects.
  2. Submit a first draft review of the background (and introduction) of the literature that supports and surrounds your thesis/aim. This synthesis of research demonstrates how the research questions emerge. They highlight how the gap you are filling is a crucial one for attention. It provides evidence of the purpose of a project and outlines clear research question/s that are aligned with the methodology planned to execute this project.
  3. Understanding and minimizing bias in research.
To Do

To Do

  1. Continue to work on your independent applied project
  2. Submit your background and introduction review of the literature due this module/week, (Sunday!):
      1. Use the template provided, which provides prompts to help you organize your submission into parts that are important to include in the background of your project.
      2. This submission must include a clear aim at the end of the introduction and research questions.
      3. This submission must be a thorough review of the literature around your aim (again, if there is too much literature, then you must narrow the topic) and have clear themes supporting your thesis/aim. Themes are your method of synthesizing the literature you have reviewed in a way that is unique and comprehensive.
      4. This submission must be approved by the instructors, so take the time to carefully review your submission for clarity, alignment, and thoroughness specific to the topic. 
      5. `This submission provides the gap you are trying to fill, the goals of your research, and the research questions. It introduces the research that currently exists around your specific topic. This literature review logically brings together the purpose of your research with the methods you plan to use. You do not submit your methods section or results but they are clearly aligned with the literature review you submit.
Module 5: Producing the Applied Project – Next Sections

Capstone Goals and Objectives Goals are broad statements of what the applied project hopes to accomplish. They create a setting for the applied project. Specific objectives are statements of the applied project research question(s). Objectives should be simple (not complex), specific (not vague), and stated in advance (not after the research is done). After statement of the primary objective, secondary objectives may be mentioned

Study Design  – **This section may not be applicable to your project

  • The scientific integrity of the applied project and the credibility of the study data depend substantially on the study design and methodology. The design of the study should include information on the type of study, the research population or the sampling frame, and who can take part (e.g. inclusion and exclusion criteria, withdrawal criteria etc.), and the expected duration of the study.
  • The same study can be described in several ways, and as complete a description of the study as possible should be provided. For example, you may want to describe the study as being epidemiologic or health policy or health and social behavioral research. It may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc. If experimental, it may be described as a controlled or a non-controlled study (this is not a comprehensive list).

Methodology

  • The methodology section is the most important part of the protocol. It should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made etc.  If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined.
  • Interventions should be described in detail, including a description of the intervention, education, training etc. provided to groups or individuals.
  • Describe the procedures to be conducted.  For example: a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant’s environment, etc.).
  • Standardized and/or documented procedures/techniques should be described and bibliographic references, if not provided earlier should be provided. Instruments which are to be used to collect information (questionnaires, FGD (Focus Group Data) guides, observation recording form, case report forms etc.) must also be provided.

Ethical/Safety Considerations

  • The protocol should have a description of ethical considerations relating to the study. This should not be limited to providing information on how or from whom the ethics approval will be taken, but this section should document the issues that are likely to raise ethical concerns. It should also describe how you, the investigator, plan to obtain informed consent from the research participants (the informed consent process).
  • The safety of research participants is paramount, whether online or in person. Safety aspects of the research should always be kept in mind, and information provided in the protocol on how the safety of research participants will be ensured. This can include procedures for recording and reporting adverse events and their follow-up, for example. It is useful to remember that even administering a research questionnaire can have adverse effects on individuals – think about confidentiality or questions that may upset them.
  • The safety of confidentiality and data keeping is also paramount.

Module 5: Producing the Applied Project: Elements of Your Methodology

This week we will review these sections of the methodology chapter.  Certain elements may not apply to your paper.

This section of your paper is a detailed account of exactly what you are going to do or  what you did. The key is to be very specific and not miss anything. What you  will write in your paper will tell your readers whether your results are valid, reliable, and could be used with confidence.

For a capstone, you need to share the rationale behind what you are doing and that each of your choices was a conscious and correct choice.

Remember – when writing this section, everything changes to future tense.  This is what you are going to do!

  • Start by restating your aim and research questions
  • Design of Study or applied project deliverable (i.e., SOP, comparison of countries, cause and effect, etc.)
    • Remember, always DEFINE your method using a seminal source. For example, Narrative Literature Review should be defined using a source for the reader. Cause and Effect analysis should also have a definition from a seminal source. New SOP creation, must also have a definition. 
  • How was confidentiality maintained? 
  • How did you verify you were thorough in the literature review search to support your aim?
    • Remember, reliability and validity is important here to describe for your readers, how you maintained these important constructs. That is why thoroughness is essential.
  • What is the Setting
  • People Involved and All Resources Needed
  • Sample, including Access and Recruitment Methods
  • Past Tense is used here
Remember, in Module 4 there is an example project and in this example, there is a good example of a method that focused on results from a Narrative Literature Review. 
  • Review of the Literature and Background/Introduction
    • Include what search terms you used and in which databases you found the articles and regulations (precisely, so no use of the words “etc.”).
    • What is your inclusion/exclusion?
    • How did you select the articles that made it into the final deliverable? What criteria were required for the article to include once you found the list of articles that met your search terms?
    • LIST exactly which articles made it into the final list
    • (this must be clear, so tables are often used to identify which articles are used and which articles offer which topic. Again, see the example in Module 4).
    • Clarify which articles offered information for which research question

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HCR 593: Module 5

HCR 593: Module 5

Module 5: Producing the Applied Project: Design of Study

The first thing you will tell the reader is what kind of study or project you are doing and why it is a good fit for your applied research question.  These can be broad approaches such as qualitative, quantitative, mixed methods, or a specific design such as narrative.

Brief Descriptions of Study Designs:

  • Qualitative: 
    These types of research methods involve describing in details specific situation using research tools like
    interviews, surveys, and Observations.
  • Quantitative: 
    These types of research methods require quantifiable data involving numerical and statistical explanations.
  • Correlation/Regression Analysis:
    This research method involves determining the strength of the relationship between two or more variables (e.g.
    are violent video games correlated with aggression in children).
  • Quasi-Experimental: 
    This research involves the comparison of two groups, one which is influenced by an external source and
    another which is not influenced by an external force.
  • Experimental: 
    Use of random assignment to place participants in two groups: an experimental group which receives
    intervention, and another control group without any intervention. It is using a positive control for you to base it
    or compare it in your result.
  • Meta-Analysis: 
    This research method is useful for finding out the average impact of several different studies on a hypothesis.

 

Example:   The proposed study will use  a quasi-experimental design with electronic surveys administered to participants  before and then 6 months following the implementation of the new teaching program.

You can use articles or books to back up your choices  on your approach.

Three and a half minute video that gives a quick overview of the two main types of research (qualitative versus quantitative – and how to mix the two together if needed for a mixed methods approach).

HCR 593-Module 5

HCR 593-Module 5

Where is your study taking place? You will need to place it within its geographic setting as well as  local ( such as a facility or organization).
Provide enough background information about the setting so the reader understands the context in which the study or problem is taking place.
Details can include:
  • Population demographics
  • Socioeconomic factors
  • Environmental factors
  • Cultural factors.

If you are doing a quality -improvement project, include all of the facility or organization information that the reader needs to understand the problem. This may include a description of the organizational culture in addition information related to:

  • Administration
  • Management
  • Leadership structures
  • Financial data
  • Staffing
  • Involved populations, such as patients.

Anything that could  influence the implementation or outcomes of your project, for better or worse, should be discussed.

Module 5: Producing the Applied Project: Sample Population

  • What population are you drawing your sample from?
  • Who is going to participate in your study or project?
  • How many participants do you need? Is there a minimum?
  • How are you going to get them?

You need to first look at the type  of  sample design you are going to use ( convenience, purposive, random, consecutive) and why you chose that design.

Next, you need to establish your  sampling frame (the general population from which you will recruit your participants).  Example: For a study of bereaved parents of estranged children, the sampling frame might be parents attending a grief support group in a particular region of the United States.

Then you must tell us who you want to recruit from that population.

You need to specify exactly who qualifies to participate

  • Develop inclusion and exclusion criteria (I/E)
  • Characteristics for I/E  may include
    • Demographics (age, sex, educational level, marital status, ethnicity, occupation)
    • Presence or absence of an illness or health condition
    • Duration of illness or health condition
    • Number of years phenomenon being  experience
  • Professional role
  • Primary language
  • Literacy
  • Previous experience with intervention
  • Location

Example

The study will include a purposive sample of women in western Uganda who have experienced obstetric fistula. Inclusion criteria are women 18 years of age and older with a vesicovaginal or rectovaginal fistula  secondary to prolonged obstructed labor. Exclusion criteria will be women who have had their fistula for longer than five years so that the data reflect current sociocultural norms.

Module 5: Bias in Research

As you develop your project, take time to see if you have identified any potential “bias” in your approach, in your population, and in your analysis. How will you approach bias that you identify.

Resources: Bias in Research.pdf– attached file
This video discusses the concept of bias in research. Bias is evident when researching an issue that is polarizing or when financial gain is at stake. Even without these elements, bias exists in research because of other factors including researchers wanting a particular result to occur.
Every project contains some level of bias. It is our responsibility as the researcher to identify and limit bias.

SOWK 602

SOWK 602

Critical Perspectives in Urban Social Work with African Americans

Purpose

This assignment assesses students’ ability to synthesize theory, critique dominant practice models, and apply culturally grounded frameworks to urban social work practice with African Americans.

Assignment Instructions

Write a 2–3 page paper (APA format) that integrates concepts from the assigned readings to address the following components:

Section I: Theoretical Foundations (Analysis)

Using the readings by Mazama (Afrocentric paradigm) and Littlefield and/or Few (Black Feminist/Womanist perspectives):

Explain the core assumptions of these frameworks.

Analyze how they center African American history, culture, spirituality, gender, and collective identity.

Discuss how these perspectives redefine “helping,” “healing,” and “competence” in urban social work.

Section II: Race, Identity, and Structural Racism (Evaluation)

Drawing on Boyd-Franklin, Alcántara et al., and related readings:

Evaluate how racism, racial identity development, and racialized trauma impact African American individuals and families in urban environments.

Critically assess limitations of traditional clinical or policy approaches that fail to address structural and historical realities.

Discuss how ignoring these dynamics can lead to misdiagnosis, ineffective intervention, or ethical harm.

Section III: Practice Application (Application)

Select one urban social work practice area (e.g., mental health, family therapy, child welfare, schools, housing, or criminal justice):

Apply at least two theoretical perspectives from the readings to describe how you would:

Conduct assessment

Engage clients and communities

Design interventions

Identify specific practice strategies that reflect cultural humility, anti-racist practice, and social justice.

Explain how your approach aligns with NASW values and ethical responsibilities.

Conclusion

Briefly reflect on how these critical perspectives reshape your understanding of your role as a social worker in urban African American communities.

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