DMID Interventional Protocol Template Version 2.0
28 April 2005
Protocol Title Version number and date
GENERAL INSTRUCTIONS – delete this box from the submitted Protocol
This template is for students in the Virginia University of Lynchburg Doctor of Healthcare Administration Research Practicum course who are preparing a detailed protocol for a study involving human subjects. Depending on the nature of what you are doing, some sections may not be applicable to your research. If a section is not applicable, delete. You may delete subsections that are not applicable. The full research protocol must be uploaded to Moodle to be considered complete. This includes the IRB Application with research protocol, Informed Consent Document (s), Recruitment Collateral, and any other supporting documentation. Applications with ANY missing elements will be considered incomplete and will be graded accordingly.
Use this template to create a study protocol as follows:
· Red text represents instructions to you – to be deleted from the final version
· Blue text represents guidance on suggested content – to be edited and changed to black or replaced with black in the final version.
· Black text represents text that should ordinarily be incorporated as-is, if applicable
Note that the table of contents is automatically included, so do not change the content or formatting of the headings. Be sure to right click on the table of contents and select “Update field” before saving the protocol and uploading it to Moodle. As always, make sure to proofread the document before submission.
Please make sure to complete the header on this page with the protocol title and version number and date.
The submitted protocol should have no red or blue text (including the header and instruction boxes like this one). The submitted protocol should have no spelling or grammar errors. All references MUST be in APA 7 format. PROTOCOL TITLEProtocol Version Number: CompleteProtocol Version Date: day, month, year [Include if there is an external funder; otherwise, delete heading] Funding Mechanism: organization and grant or contract #[Include if there is industry support; otherwise, delete heading] Industry Support provided by: name of industryPrincipal Investigator: name Phone: Complete E-mail: Complete[Include if the study has a medical monitor; otherwise, delete heading] Medical Monitor: name
Table of Contents
1List of Abbreviations4
2Protocol Summary4
3Background/Rationale & Purpose5
3.1Background Information5
3.2Rationale and Purpose5
4Objectives5
4.1Study Objectives5
4.2Study Outcome Measures6
4.2.1Primary Outcome Measures6
4.2.2Secondary Outcome Measures6
5Study Design6
6Potential Risks and Benefits7
6.1Risks7
6.2Potential Benefits8
6.3Analysis of Risks in Relation to Benefits8
7Study Subject Selection8
7.1Subject Inclusion Criteria8
7.2Subject Exclusion Criteria8
7.3Recruitment Methods9
7.4Compensation for Participation in Research Activities9
7.5Withdrawal of Pa ...
Definition. A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
Here's a list of steps on how to write a research protocol:
Write a project summary. ...
Create a section for basic information. ...
Offer the rationale for your research study. ...
State the study's goals and objectives. ...
Detail the study design. ...
Define the methodology. ...
List safety considerations. ...
Create steps for the follow-up process.
Role of protocol in clinical research.
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analyzed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
A systematic review (SR) is a rigorous and organized method to synthesize
the evidence from multiple studies on a particular research question or topic.
The purpose of a systematic review is to identify, appraise, and summarize all
available evidence relevant to a specific research question in a transparent
and replicable manner.
It aims to provide a comprehensive overview of academic literature
concerning a particular research question of topic.
This presentation explores the steps nee
Your new clientsThe Wagner’s – Scott and Ella are a young marri.docxDustiBuckner14
Your new clients:
The Wagner’s – Scott and Ella are a young married couple who just purchased a
townhome in the Heights area of Houston. He works in finance, and she is a Dr. They
prefer clean lines, not a lot of “fluff” but want their home to be comfortable and inviting.
The bedroom and bathroom need to have a relaxing “get away” feel as they both work
long hours. They have no children.
Develop and Prepare (3) Written Design Concepts for a Master Bedroom Suite - You
must use the “What, Why & How” Method presented in class
project will have its own unique Design Concept
You will use your Design Concepts to make selections and provide an overall design
scheme for each client
You will find images of all of your selections and include in your presentation
You will create (3) Schemes and present in a digital format.
Design/Presentation requirements are below:
Bedroom Materials/Finishes: Ceiling/Walls/Floors/Window Treatments
Bedroom Furniture Selections: Bed, Nightstands, Dresser, Art/Accessories, TV
Bedroom Light Fixtures
Bathroom Materials/Finishes: Ceiling/Walls/Floors/Millwork (counter & cabinets)
Bathroom FF&E Selections: Tub, Sinks, Shower & Sink Fittings, Lighting
Remember, you need to think about how you would like the bedroom to function,
and what your “concept” would be. Think about seating areas, sleeping area,
storage, dressing area, etc. This is your opportunity to be creative!
What is your concept statement? What is the programming? (Here are some questions
to ask)
What size bed?
What types of furniture needed? (Headboard, dresser, lounge chair, rug, etc.)
Comfort level and design style (contemporary, traditional, transitional)
Lighting and TV requirements?
Accessories?
You will:
Take the plan that was given to you and research and decide what furnishings
you would like to propose for each client.
Create a Programming slide identifying needs and requirements and your
solutions.
Create a brief Concept Statement slide summarizing your design intent. This
statement should also communicate the mood or feel you are attempting to
evoke.
Create a “working” presentation of your suggestions to review. This will consist of
several slides with your suggestions.
.
Writing Conclusions for Research PapersWhat is the purpose.docxDustiBuckner14
Writing Conclusions for Research Papers
What is the purpose of a conclusion?
A conclusion is supposed to provide the “final verdict,” or the “moral of the story” for the essay.
It is the writer’s last attempt at providing a memorable ending to the paper.
It explains why the topic is important and what the reader should learn from it.
A conclusion is not…
A repetition of the thesis statement and its points
Only a summary of the paper’s main points
A paragraph so detailed is resembles a body paragraph
A paragraph that goes into a new or unrelated topic
Two or three sentences long (i.e. “two sentences plus a catchy quote.”
Example of good conclusions
Making a recommendation or offering a solution to the problem
In conclusion, social media is not only responsible in many cases for ruining a marriage, sometimes it is responsible for ruining the entire family balance. These social platforms affect the stability of the couple creating a detachment in the everyday life; once the stability is broken and the distance starts to increase, most likely a sense of jealousy will generate and possibly lead to infidelity. It is easy for many users to blame social media for the end of their marriage, and because of this, it is important to use social media for a limited time with non-malicious intentions. The responsible use of the platforms may protect marriages from being permanently damaged and give a couple the possibility to live a much happier life together.
Painting a picture of the future if the problem is solved or handled correctly
Modern technology continues to prove its merit within the medical field furthering our understanding of ADHD as well as providing invaluable resources available to the public and educational institutions in which to simplify the management of this troublesome condition. It’s used to aid children throughout their academic endeavors, which, will dictate how they enter society and cope with symptoms that will be with them until future technology can find a cure. Data collection will only grow as technology is further implemented in ADHD treatment and is the key to developing the individual treatment plans that will help future generations thrive. The benefits of modern technology towards adolescents suffering from ADHD are plentiful and may one day eliminate the condition. This future is welcomed and one with great promise.
Painting a picture of the future if the problem is NOT solved or handled correctly
All in all, technology is growing at an extraordinarily exponential pace allowing us to be more connected and in tune than ever before. However, while we grow more connected online, we grow more apart in real life which in turn hurts our social skills, disconnects us from each other, degrades our interpersonal skills, makes it easier to commit crimes, and pulls friends and family apart. With almost everything in life there is undoubtedly an equal number of cons.
More Related Content
Similar to DMID Interventional Protocol TemplateVersion 2.028 April 2005
Definition. A clinical research protocol is a document that describes the background, rationale, objectives, design, enrollment criteria, methodology, data recording requirements, statistical considerations, and organization of a clinical research study.
Here's a list of steps on how to write a research protocol:
Write a project summary. ...
Create a section for basic information. ...
Offer the rationale for your research study. ...
State the study's goals and objectives. ...
Detail the study design. ...
Define the methodology. ...
List safety considerations. ...
Create steps for the follow-up process.
Role of protocol in clinical research.
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analyzed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.
A systematic review (SR) is a rigorous and organized method to synthesize
the evidence from multiple studies on a particular research question or topic.
The purpose of a systematic review is to identify, appraise, and summarize all
available evidence relevant to a specific research question in a transparent
and replicable manner.
It aims to provide a comprehensive overview of academic literature
concerning a particular research question of topic.
This presentation explores the steps nee
Your new clientsThe Wagner’s – Scott and Ella are a young marri.docxDustiBuckner14
Your new clients:
The Wagner’s – Scott and Ella are a young married couple who just purchased a
townhome in the Heights area of Houston. He works in finance, and she is a Dr. They
prefer clean lines, not a lot of “fluff” but want their home to be comfortable and inviting.
The bedroom and bathroom need to have a relaxing “get away” feel as they both work
long hours. They have no children.
Develop and Prepare (3) Written Design Concepts for a Master Bedroom Suite - You
must use the “What, Why & How” Method presented in class
project will have its own unique Design Concept
You will use your Design Concepts to make selections and provide an overall design
scheme for each client
You will find images of all of your selections and include in your presentation
You will create (3) Schemes and present in a digital format.
Design/Presentation requirements are below:
Bedroom Materials/Finishes: Ceiling/Walls/Floors/Window Treatments
Bedroom Furniture Selections: Bed, Nightstands, Dresser, Art/Accessories, TV
Bedroom Light Fixtures
Bathroom Materials/Finishes: Ceiling/Walls/Floors/Millwork (counter & cabinets)
Bathroom FF&E Selections: Tub, Sinks, Shower & Sink Fittings, Lighting
Remember, you need to think about how you would like the bedroom to function,
and what your “concept” would be. Think about seating areas, sleeping area,
storage, dressing area, etc. This is your opportunity to be creative!
What is your concept statement? What is the programming? (Here are some questions
to ask)
What size bed?
What types of furniture needed? (Headboard, dresser, lounge chair, rug, etc.)
Comfort level and design style (contemporary, traditional, transitional)
Lighting and TV requirements?
Accessories?
You will:
Take the plan that was given to you and research and decide what furnishings
you would like to propose for each client.
Create a Programming slide identifying needs and requirements and your
solutions.
Create a brief Concept Statement slide summarizing your design intent. This
statement should also communicate the mood or feel you are attempting to
evoke.
Create a “working” presentation of your suggestions to review. This will consist of
several slides with your suggestions.
.
Writing Conclusions for Research PapersWhat is the purpose.docxDustiBuckner14
Writing Conclusions for Research Papers
What is the purpose of a conclusion?
A conclusion is supposed to provide the “final verdict,” or the “moral of the story” for the essay.
It is the writer’s last attempt at providing a memorable ending to the paper.
It explains why the topic is important and what the reader should learn from it.
A conclusion is not…
A repetition of the thesis statement and its points
Only a summary of the paper’s main points
A paragraph so detailed is resembles a body paragraph
A paragraph that goes into a new or unrelated topic
Two or three sentences long (i.e. “two sentences plus a catchy quote.”
Example of good conclusions
Making a recommendation or offering a solution to the problem
In conclusion, social media is not only responsible in many cases for ruining a marriage, sometimes it is responsible for ruining the entire family balance. These social platforms affect the stability of the couple creating a detachment in the everyday life; once the stability is broken and the distance starts to increase, most likely a sense of jealousy will generate and possibly lead to infidelity. It is easy for many users to blame social media for the end of their marriage, and because of this, it is important to use social media for a limited time with non-malicious intentions. The responsible use of the platforms may protect marriages from being permanently damaged and give a couple the possibility to live a much happier life together.
Painting a picture of the future if the problem is solved or handled correctly
Modern technology continues to prove its merit within the medical field furthering our understanding of ADHD as well as providing invaluable resources available to the public and educational institutions in which to simplify the management of this troublesome condition. It’s used to aid children throughout their academic endeavors, which, will dictate how they enter society and cope with symptoms that will be with them until future technology can find a cure. Data collection will only grow as technology is further implemented in ADHD treatment and is the key to developing the individual treatment plans that will help future generations thrive. The benefits of modern technology towards adolescents suffering from ADHD are plentiful and may one day eliminate the condition. This future is welcomed and one with great promise.
Painting a picture of the future if the problem is NOT solved or handled correctly
All in all, technology is growing at an extraordinarily exponential pace allowing us to be more connected and in tune than ever before. However, while we grow more connected online, we grow more apart in real life which in turn hurts our social skills, disconnects us from each other, degrades our interpersonal skills, makes it easier to commit crimes, and pulls friends and family apart. With almost everything in life there is undoubtedly an equal number of cons.
What Is Septic TankSeptic or septic typically is used t.docxDustiBuckner14
What Is Septic Tank?
"Septic" or "septic" typically is used to describe the anaerobic bacteria environment that was created in Tank and decomposes to mineralizes domestic wastewater in the tank.
What exactly is septic tank Septic tank? It is a constructed in a scientifically sound underground chamber typically made of rcc, fiberglass, plain concrete, steel, or plastic. the domestic water, wastewater and fecal materials, excretory and toilet products flow into it to treat the primary source of waste material , which decomposes and transform into semi-solid or solid settleable liquid sludge.
In the United States, there are several types of ready-made Septic tanks that are available in the market. They include concrete septic tank plastic septic tank, as well as fibreglass septic tanks. Most well-known and widely used are concrete septic tanks for homes, based on the state and local rules and regulations.
When it comes to "what is a concrete septic tanks?", concrete septic tank is a basic design, water-tight container constructed from RCC or plain concrete typically rectangular or circular in shape and available in one chamber, two chambers, or three chambers that are that are used to treat primary liquid waste.
The typical capacity ranges from 500 to 1250 gallons 500 gallon or 750 gallon tanks are adequate for a two-bedroom home or a 1000 gallon concrete tank is sufficient for a three bedrooms, and a 1250 gallon septic tank is sufficient for a four bedroom house or a family of four.
In this regard, "what is the septic tank?", the septic tank is a single chamber or multi-chamber underground compartment that is composed out of RCC concrete fiberglass, plastic or steel used for the first-class treatment for domestic wastewater and fecal material as well as excretory products and toilets that
Also Read:
Rooftop Design Ideas
What Are Septic Tank?
What is the septic tanks? Septic tank is an submerged sedimentation tanks for the primary treatment of household waste and fecal materials via the process of bioanaerobic digestion, or decomposition, which results in semi-solid or solid sludge that can be settled.
The majority of septic tanks for homes can hold between 4000 and 7500 millilitres or 1,000 - 2000 gals of effluent, or semi-solid sludge.
What Size of Septic Tank Do I Need
?
In this article, we'll be talking about underground septic tanks and the size is a reference to the tank's total capacity for handling. Read our article about above ground septic tanks to get additional information about these tanks and the systems.
The minimum requirements for capacity of a septic tank are based on various variables. The state, county or city guidelines may require approved sizes , as can the material used for tank construction and its installation.
The local geography and soil conditions play a significant role in the effectiveness of the system, which could affect the size of drain fields and the size of the septic tank.
The type of septic .
· You should respond to at least two of your peers by extending, r.docxDustiBuckner14
· You should respond to at least two of your peers by extending, refuting/correcting, or adding additional nuance to their posts. Your reply posts are worth 2 points (1 point per response.)
· All replies must be constructive and use literature where possible.
# 1
Hearing & Eye Age-Related Diseases
Presbycusis, also known as age-related hearing loss, is a debilitating disease with a complicated etiology that affects tens of millions of people worldwide and roughly half of those over 65 in the United States (Say et al., 2021). The loss is usually bilateral, causing difficulty hearing high-pitched tones and conversational speech (Meiner & Yeager, 2019). The causes of age-related hearing loss are thought to be genetic and environmental. Men are more affected by this condition than women. This condition's origin is yet unknown.
Some signs and symptoms that could be seen in patients with this condition are not answering when spoken to, talking loudly, paying attention to the speaker's lips, turning up the radio or TV volume, putting one palm over one ear, and tilting the head to one side when someone is speaking (Meiner & Yeager, 2019). The causes of presbycusis are multifaceted. In addition to physiologic and anatomical alterations brought on by aging-related deterioration, genetic factors are among the additional contributing elements (Cheslock & De Jesus, 2022). It is believed that glutamate signaling, glucocorticoids, and sex hormones all contribute to it. Hearing loss occurs more frequently in postmenopausal women who use progestin and a combination of hormone replacement therapy. Presbycusis has also been linked to exposure to loud noises and ototoxic substances such as salicylates, loop diuretics, aminoglycosides, and some chemotherapeutic drugs. Ototoxicity has also been linked to certain occupational and environmental exposures to toxins such as toluene, styrene, lead, carbon monoxide, mercury, and other toxins (Cheslock & De Jesus, 2022). This problem has also been associated to a history of ear infections and the presence of several systemic disorders.
Studies aimed at establishing a clear association for the cause have not been successful. As a result, the diagnosis entails eliminating other potential causes of hearing loss, such as infections, head trauma, metabolic disorders, vascular diseases, and heart disease (Meiner & Yeager, 2019). It is important for nurses when caring for patients with this condition to speak clearly and use a normal tone of voice. Patients and their families need to be instructed on how to use and where to obtain assistive listening devices (Meiner & Yeager, 2019). Nurses must educate patients and family members that when using hearing aids, they need to perform daily listening and battery checks. These devices must be stored in a hearing aid drying container with batteries removed.
Vision is an important sense that is needed to complete ADLs. Age-related changes and macular or.
You are a medical student working your way throughcollege and ar.docxDustiBuckner14
You are a medical student working your way through
college and are assigned to a hospital given background information on a patient.
You were provided the chief complaint and long-term history of the patient
outlined below. You are asked by the nurse in charge to read the following case,
investigate the topic (Diabetes mellitus and chronic renal failure) and complete a
written report in MLA format including references addressing each of the
questions identified below.
.
[removed]THIS IEP INCLUDES FORMCHECKBOX Transitions.docxDustiBuckner14
[removed]
THIS IEP INCLUDES:
FORMCHECKBOX
Transitions
FORMCHECKBOX
Interim Service Plan
NEW YORK CITY
BOARD OF EDUCATION
INDIVIDUALIZED EDUCATION PROGRAM
CONFERENCE INFORMATION
CSE Case#
-
Home District:
Service District:
Date:
/
/
Type:
STUDENT INFORMATION
*Age as of the date of the conference
Name:
NYC ID#
- -
Date of Birth
/ /
Gender
FORMDROPDOWN
Address:
Age:
Phone:
( ) -
English LAB
Year
Spanish LAB
Year
Grade
FORMDROPDOWN
Language(s) Spoken/Mode of Communication
FORMDROPDOWN
Primary Agency with whom student is involved
Name of Contact
FORMTEXT
Phone:
( ) -
Agency Case#
PARENT/GUARDIAN INFORMATION
Relationship to Student
Name:
FORMDROPDOWN
Address:
Phone (Home):
( ) -
Phone (Work):
( ) -
Interpreter Required
FORMCHECKBOX
Yes
FORMCHECKBOX
No
Preferred Language/ Mode of Communication
FORMDROPDOWN
SPECIAL MEDICAL/PHYSICAL ALERTS
(Refer to Health & Physical Development Page for additional details.)
The student has
FORMCHECKBOX
medical conditions and/or FORMCHECKBOX
physical limitations which affect his/her FORMCHECKBOX
learning FORMCHECKBOX
behavior and/or FORMCHECKBOX
participation in school activities.
The student requires FORMCHECKBOX
medication and/or FORMCHECKBOX
health care treatment(s) or procedure(s) during the school day.
Other alerts:
SUMMARY OF RECOMMENDATIONS
Eligibility
FORMCHECKBOX
Yes FORMCHECKBOX
No
Recommended Services
Classification of Disability
FORMDROPDOWN
FORMDROPDOWN
Staffing Ratio
FORMDROPDOWN
Twelve Month School Year
FORMCHECKBOX
Yes FORMCHECKBOX
No
Recommended Services for the Twelve Month School Year
FORMDROPDOWN
Staffing Ratio
FORMDROPDOWN
Other Recommendations (Check all that apply) .
Using the Integrated Model of Work Motivation Figure 12.1 (Latham, 2.docxDustiBuckner14
Using the Integrated Model of Work Motivation Figure 12.1 (Latham, 2011), describe specific practices that may or may not have a positive effect on workplace attitudes, motivation, and job satisfaction. Evaluate the possible future directions and potential of leadership practices for positive workplace attitudes, motivation, and job satisfaction within the current workplace.
.
What We Can Afford” Poem By Shavar X. Seabrooks L.docxDustiBuckner14
“What We Can Afford”
Poem By: Shavar X. Seabrooks
Like the rice fields of Charleston, the wind blows limitlessly.
The slaves give peace to the land that hands they have touch.
In the mist of blood, sweat and tears, still the heartbeat sticks in the sweetgrass of mercy.
Gathered near the Stono River, they earned for freedom press against time which is not a
companion.
Fort Mose just in their reach, still time is not their companion.
Looking back to the Ancient Civilization, were Dark Skin People were King and Queens.
Wear Kenta cloths adorning the skin like silk.
And were the land being harvest for love and not for gain.
The children to grow and not wanting to be enslaved and the lips of the masters impales
the dreams.
Yet, the circle that remains the same, but the horizon is just to come.
The wind shall tell the truth and the African Experiences will be a drum of remembrance.
References
Higginbotham, R. D., Wickwire, F., & Wickwire, M. (1970). Cornwallis: The American
adventure. The Journal of Southern History, 36(4), 591. doi:10.2307/2206317
Morgan, E. S. (1972). Slavery and freedom: The American paradox. The Journal of American
History, 59(1), 5. doi:10.2307/1888384
Video clips on Ancient African Civilizations, Kente Cloth
Miranda Isabella Hurt
20 October 2020
Haiku about Emmett Till
Just a young black boy
Stripped of all his life and dreams
Where is the justice
Cinquain about the Civil Rights Movement
A movement ignited by Parks
A peaceful dream promoted by Dr. King
An education organized by Clark
A call to let freedom ring
The first poem is about the murder of Emmett Till. Till’s tragic tale is described in the Eyes on the Prize:
Awakenings and in the study guide. On August 28, 1955, “Emmett Till, a black boy from Chicago visiting
his uncle Moses Wright in Mississippi, is murdered for inappropriately addressing a white woman (page
14).” Even though Till’s murderers eventually confessed to the crime, they were never charged for his
murder (because of the no double jeopardy clause in the fifth amendment of the Constitution). This is
one of many instances of injustice against African Americans in the south during the Civil Rights
Movement. However, even now in the 21st century, African Americans are still facing prejudices and
being killed by cops, the people who are supposed to protect them.
The second poet highlights three big names of the Civil Rights Movement, Rosa Parks, Dr. Martin Luther
King Jr, and Septima Clark. The Eyes on the Prize videos mention King a lot, because he was quite a
significant man, and The Awakenings and Ready from Within discusses Rosa Parks. Rosa Parks sparked
the Montgomery bus boycott by refusing to give up her seat to a white person. Septima Clark’s impact
on the Civil Rights Movement with her citizenship schools was the main topic of Ready from Within.
Clark played a crucial role in educating many African American.
What are the techniques in handling categorical attributesHow.docxDustiBuckner14
What are the techniques in handling categorical attributes?
How do continuous attributes differ from categorical attributes?
What is a concept hierarchy?
Note the major patterns of data and how they work.
What is K-means from a basic standpoint?
What are the various types of clusters and why is the distinction important?
What are the strengths and weaknesses of K-means?
What is a cluster evaluation?
.
University of the CumberlandsSchool of Computer & Information .docxDustiBuckner14
University of the Cumberlands
School of Computer & Information Sciences
ISOL-536 - Security Architecture & Design
Chapter 8: Business Analytics
Chapter 8: Business Analytics
8.1 Architecture
8.2 Threats
8.3 Attack Surfaces
8.3.1 Attack Surface Enumeration
8.4 Mitigations
8.5 Administrative Controls
8.5.1 Enterprise Identity Systems (Authentication and Authorization)
8.6 Requirements
8.1 Architecture
Data science is a set of fundamental principles that guide the extraction of knowledge from data. Data mining is the extraction of knowledge from data via technologies that incorporate these principles.
Like many enterprises, Digital Diskus has many applications for the various processes that must be executed to run its business, from finance and accounting to sales, marketing, procurement, inventory, supply chain, and so forth. A great deal of data is generated across these systems. But, unfortunately, as a business grows into an enterprise, most of its business systems will be discreet. Getting a holistic view of the health of the business can be stymied by the organic growth of applications and data stores.
8.1 Architecture – Cont.
Figure 8.1 Business analytics logical data flow diagram (DFD).
8.1 Architecture – Cont.
Figure 8.2 Business analytics data interactions.
Figure 8.2 is a drill down view of the data gathering interactions of the business analytics system within the enterprise architecture. Is the visualization in Figure 8.2 perhaps a bit easier to understand? To reiterate, we are looking at the business analysis and intelligence system, which must touch almost every data gathering and transaction-processing system that exists in the internal network. And, as was noted, business analytics listens to the message bus, which includes messages that are sent from less trusted zones.
5
8.2 Treats
Figure 8.3 Business analytics system architecture.
As we move to system specificity, if we have predefined the relevant threats, we can apply the threats’ goals to the system under analysis. This application of goals leads directly on to the “AS” of ATASM: attack surfaces. Understanding your adversaries’ targets and objectives provides insight into possible attack surfaces and perhaps which attack surfaces are most important and should be prioritized.
It’s useful to understand a highly connected system like business analytics in situ, that is, as the system fits into its larger enterprise architectural context. However, we don’t yet have the architecture of the system itself. Figure 8.3 presents the logical components of this business analytics system.
There are five major components of the system:
1. Data Analysis processing
2. Reporting module
3. Data gathering module
4. Agents which are co-located with target data repositories
5. A management console
6
8.3 Attack Surfaces
In this context, where several components share the same host, how would you treat the communications between them? Should.
Theresa and Mike fully support creating a code of conduct for th.docxDustiBuckner14
Theresa and Mike fully support creating a code of conduct for the newly merged JEANSTYLE organization. They have asked you to recommend how they should approach the development of the code of conduct, especially given the need to merge the companies into one team with a shared mission, vision, and values. They are interested in knowing how the code of conduct will help establish the new organizational culture of JEANSTYLE.
Review the
scenario
( https://class.coloradotech.edu/CbFileShareCommon/ctu/INTD670/Assignment_Assets/ProblemB.pdf ) for this course, and address the following questions:
What set of steps should be used to create the
code of conduct
?
What topics should be included in the code of conduct?
What impact does a code of conduct have on an organization's culture?
Access the
assignment template
.
4-6 PAGES NEEDED
.
Unit VII 1. Suppose a firm uses sugar in a product tha.docxDustiBuckner14
Unit VII
1. Suppose a firm uses sugar in a product that you purchase. The firm vertically integrates by purchasing sugar farms that produce the sugar organically and in a way that makes it also sustainable for the environment. How would that influence your demand for that product? What other purpose than profitability might cause the firm to make this decision to vertically integrate in this way? 200 words min
2.
Identify a skill that you learned in this course, and explain how you can apply it to increase success in your career in a real-world scenario. 200 words3.
Instructions
Your assignment is to provide a final report for Ruby Red Movie Theater in which you address the concerns that have been outlined in the previous six units of this class, indicating any outsourcing or vertical integration options Ruby Red Movie Theater may be able to implement.
Be specific regarding the analysis you performed in each area of study. Your recommendations for improvements for the theater should be based on economic theory and your analysis. Your complete analysis of the theater, the industry, and opportunities that may exist are crucial for the future profitability of the theater.
Revise the information from previous assignments as needed and pull everything together to create a cohesive, comprehensive report. What this means is that this final report should be original updated work, though it is based on your previous assignments. Do not just copy and paste your previous assignments into one paper. Also, be sure to incorporate any suggestions your instructor made in your previous assignments.
New information will be added for Unit VII, which will focus on the information provided in this unit. The topics for this section will include why firms exist, the factors that create a situation where vertical integration is desirable, and why firms would use outsourcing, as well as how this information can be applied to the Ruby Red Movie Theatre.
The following is a list of items and sections you should include in your final report. Replace the unit numbers with appropriate titles for the information in each section.
· Title page
· Table of contents
· Introduction
· Unit I
· Results write-up from Unit I, including recommendations
· Unit II
· Results write-up from Unit II, including recommendations
· Unit II Tables
· Unit II Graphs
· Unit III
· Results write-up from Unit III, including recommendations
· Unit IV
· Results write-up from Unit IV, including recommendations
· Unit IV Tables
· Unit V
· Results write-up from Unit V, including recommendations
· Unit V Tables
· Unit VI
· Results write-up from Unit VI, including recommendations
· Unit VII
· Results write-up from Unit VII, including recommendations
· Conclusions and final recommendations
· Reference page
· Insert labeled tables after the reference page
Adhere to APA Style (APA 7th edition) when constructing this assignment, including in-text citations and references for all sources t.
Title If a compensation system works well for one business, that .docxDustiBuckner14
Title:
If a compensation system works well for one business, that same compensation system should not work well for other businesses.”
Company we choose : FEDEX & STARBUCKS
Introduction:
Contextual variables (Firm A and Firm B)
Based on the Title above and the companies provided just provide the overall introduction in the report and the contextual variables where we tell about the companies ( FEDEX & STARBUCKS)
.
Review the Article Below Keller, J. G., Miller, C., LasDulce, C.docxDustiBuckner14
Review the Article Below:
Keller, J. G., Miller, C., LasDulce, C., & Wohrle, R. G. (2021). Using a community-based participatory research model to encourage parental involvement in their children’s schools.
Children & Schools
,
43
(3), 149–158.
https://doi.org/10.1093/cs/cdab015
The article takes a participatory action approach. The text lists 7 criteria for participatory action research. How does the project described in the article you selected meet these 7 criteria?
Social phenomena are influenced by macro-level social influences.
Social structures and dynamics are contextualized by history
Theory and practice are simultaneously engaged.
Dialogue between the subject and the object is transformed into a single subject–subject
Research and action become a single process
Community and researcher produce knowledge together for social transformation
Research results should be immediately applied to a concrete state of affairs.
.
Teachers reach diverse learners by scaffolding instruction in ways t.docxDustiBuckner14
Teachers reach diverse learners by scaffolding instruction in ways that support content literacy and learning.
Think back when you were a student or during your own field experiences in which culturally or linguistically diverse learners were part of a classroom.
1. How did these students participate in the class? How did the teacher respond? Were modifications made for them? If so, describe the nature of those modifications.
2.
Language and culture are inextricably connected
. What are the implications of this statement for classroom practice?
Search entries or author
.
ScenarioThe HIT Innovation Steering Committee of a large.docxDustiBuckner14
Scenario
The
HIT Innovation Steering Committee
of a large, integrated healthcare system is in the process of examining the potential impact for new emerging technologies. The Committee is aware that HIT is rapidly changing and that they need to proactively plan for upcoming changes. As a member of this committee, select an emerging technology discussed in the module readings and lectures. Research how this new technology could affect patients, healthcare delivery and data analytics. Based on your learnings, write a White Paper for the Committee describing your findings and recommendations.
Instructions
Create a WHITE PAPEr that includes:
Discussion on why emerging technology poses a challenge for healthcare organizations
Discussion of the chosen emerging technology including reason(s) for selection
Discussion on the potential impact on patients, healthcare delivery, and healthcare organizations
Provide insight into how extracting and analyzing the potential data (administrative, financial, and clinical) benefits or poses challenges for healthcare organizations
Provide recommendations on how the organization can strategically plan for emerging technology
Reference page of resources utilized
A - 4 - Mastery
Clear and thorough discussion on why emerging technology poses a challenge for healthcare organizations, including multiple examples and supporting details.
A - 4 - Mastery
Clear and thorough discussion of the chosen emerging technology including reason(s) for selection, including multiple examples and supporting details.
A - 4 - Mastery
Clear and thorough discussion on potential impact to patients, healthcare delivery, and healthcare organizations, including multiple examples and supporting details
A - 4 - Mastery
Clear and thorough explanation of how extracting and analyzing the potential data (administrative, financial, and clinical) benefits or poses challenges for healthcare organizations.
A - 4 - Mastery
Clear and thorough recommendations on how the organization can strategically plan for emerging technology, including multiple examples and supporting details.
.
Space ... the final frontier. So, as I am sure everyone knows, .docxDustiBuckner14
Space ... the final frontier. So, as I am sure everyone knows, the National Aeronautical Space Administration (NASA) is located right here in H-town. OK, well, technically in Clear Lake. One rarely thinks of space exploration as an extension of government, but remember, one of President John F. Kennedy's challenges promises to the nation was sending an American to the moon.
Well recently, with the call to put an astronaut on Mars by President George W. Bush, and with the founding of SpaceX by Elon Musk, the discussion about space exploration has re-emerged. I would like you to address the following debate. What extent should the government use tax-payer dollars to fund space exploration? Should we leave space travel up to the private sector, or should the government invest more NASA mission. Perhaps there is a healthy balance between the two? What are your thoughts.
Below are some recent (and old) articles about this subject. In addition, I have also linked a report that NASA contributed to about the benefits of space exploration, and a finding by the Congressional Budget Office suggesting how money could be spent elsewhere.
you must reference at least one article correctly in the body of the post (not simply cutting and pasting the URL after your post), respond respectfully to one-classmate, use college level grammar and sentence structure, and be at least 250 words long.
Selected Articles:
https://www.pewresearch.org/science/2018/06/06/majority-of-americans-believe-it-is-essential-that-the-u-s-remain-a-global-leader-in-space/
https://www.cbo.gov/budget-options/2018/54771
https://www.nytimes.com/2020/07/28/science/mars-nasa-science.html
https://abcnews.go.com/Business/spacex-ula-score-multi-million-dollar-military-launch/story?id=72280019
https://www.planetary.org/articles/cost-of-perseverance-in-context
https://www.nasa.gov/sites/default/files/files/Benefits-Stemming-from-Space-Exploration-2013-TAGGED.pdf
https://www.texastribune.org/2017/03/21/trump-signs-nasa-bill-aimed-landing-mars/
https://newrepublic.com/article/60759/case-cutting-nasas-budget
.
The Internal EnvironmentInstitutionStudent’s name.docxDustiBuckner14
The Internal Environment
Institution:
Student’s name:
Date:
Part 1.
In business, "corporate culture" refers to the rules, customs, and beliefs that all employees follow and are taught (Wheelen, Thomas., & Hunger, J. David, 2014). However, in today's world, the CEO, CFO, and other top executives' actions and attitudes have a direct impact on the company's culture. FedEx has a culture that demonstrates to its employees and customers how much they are valued. FedEx prioritizes service, people, honesty, innovation, responsibility, safety, and loyalty (FedEx, 2019). FedEx understands the importance of a positive work environment and a strong corporate culture in order to achieve operational success and provide excellent customer service. As a result, FedEx has implemented a "People-Service-Profit strategy" (P-S-P) and continues to promote a high-performance culture. (FedEx, 2019). Frederick Smith, the company's current CEO and founder, came up with this idea because he believed that investing in employees would result in better work and, as a result, financial success. This philosophy emphasizes the importance of treating employees with respect and dignity, as well as rewarding team members based on how well they perform their duties.
FedEx believes that its employees are the best way to make big decisions, and it attributes its success to its innovative culture. Because service providers' employees are the ones who directly interact with customers, this philosophy is especially important in the service industry. Training, giving employees power, and providing incentives are all critical in a company whose culture is based on this philosophy (Peoplematters, 2019). FedEx Corporation's plan to make more money, in my opinion, is consistent with its core value of putting people first. People who are enthusiastic about their jobs are always more creative and productive. On the review site Glassdoor, current FedEx employees gave CEO Frederick Smith an 84% approval rating, and 73% said they would recommend working there to a friend (Glassdoor, 2019). FedEx is the company most likely to hire these individuals as a result of this. In addition, some FedEx freight drivers chose not to join a union in 2017, indicating a favorable work environment (Dcvelocity, 2017). FedEx Corporation employs approximately 300,000 people in over 250 countries and territories. As a result, there are numerous programs in place to thank employees for their efforts. This demonstrates how much FedEx cares about and values its employees.
There is a list of awards and recognition programs on the main website, including "The Humanitarian Award," "The Five Star," "Bravo Zulu," and "Purple Promise" (FedEx, 2019). A five-star rating is the highest you can achieve at FedEx. The manager gives the staff theater tickets and quick cash bonuses in the form of Bravo Zulu. Pilots, couriers, customer service representatives, and meteorologists are among those who benefit from the "purple promise.
THE RESEARCH PROPOSAL BUS8100 8Chapter 2 - Literature ReviewTh.docxDustiBuckner14
THE RESEARCH PROPOSAL BUS8100 8
Chapter 2 - Literature Review
The purpose of this quantitative correlational study was to examine whether relationships
exist among job performance, transformational leadership style, and employee turnover intention
in the United States. Interest grew in the past 30 years, combining transformational leadership
and employee turnover intention, based on the assumptions that employees are likely to be
influenced by their leader’s behavior (Gyensare et al., 2016). Gyensare et al. (2016) noted
transformational leadership style was a key variable in lowered employee turnover intention and
enhanced employee well-being. Buil et al. (2019) stated job performance was an organizational
benefit deriving from transformational leadership style.
This literature review was structured to provide key concepts and related factors to the
research variables. In the first section, the researcher defined job performance and measurements
related to this performance. This included the 360-feedback and performance appraisal. The next
section discussed and measured transformational leadership style followed by employee turnover
intention. The fourth section covered contrasting and supporting theories relative to my
theoretical framework. The final section entailed profitability and a discussion of the auto
manufacturing industry.
The existing research in the literature review focused on the relationships between the
variables of employee turnover intention, transformational leadership style, and job performance.
The top journals used include the International Journal of Academic Research in Business and
Social Sciences, International Journal of Productivity and performance management, Journal of
Managerial Psychology, International Journal of Business and Management, Journal of Human
Resources in Hospitality & Tourism, International Journal of Business Administration,
International Journal of Selection & Assessment, SAM advanced management journal, and
Journal of Applied Biobehavioral Research.
To locate research for this study, EbscoHosts and Education Resources Information
Center (ERIC) were used. The keywords used in the searches include employee turnover
intention, transformational leadership style, factors of employee turnover intention, job
performance impact, employee turnover and job performance, transformational and
transactional leadership style, the cost of employee turnover intention, LMX theory, measuring
job performance, employee turnover and profit, transformational leadership theory, and
measuring employee turnover intention.
The Automotive Industry
In the early days, the majority of U.S. manufacturing was centered in a small part of the
Northwest and eastern side of the Midwest (Krugman, 1991). The early automotive
manufacturers primarily put together the completed product by components and parts brought
from outside suppliers (Peterson, 1987). Henry Ford established a vision of the automobile by
introducing the Model T .
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
DMID Interventional Protocol TemplateVersion 2.028 April 2005
1. DMID Interventional Protocol Template Version 2.0
28 April 2005
Protocol Title Version number and date
GENERAL INSTRUCTIONS – delete this box from the
submitted Protocol
This template is for students in the Virginia University of
Lynchburg Doctor of Healthcare Administration Research
Practicum course who are preparing a detailed protocol for a
study involving human subjects. Depending on the nature of
what you are doing, some sections may not be applicable to
your research. If a section is not applicable, delete. You may
delete subsections that are not applicable. The full research
protocol must be uploaded to Moodle to be considered
complete. This includes the IRB Application with research
protocol, Informed Consent Document (s), Recruitment
Collateral, and any other supporting documentation.
Applications with ANY missing elements will be considered
incomplete and will be graded accordingly.
Use this template to create a study protocol as follows:
· Red text represents instructions to you – to be deleted from
the final version
· Blue text represents guidance on suggested content – to be
edited and changed to black or replaced with black in the final
version.
2. · Black text represents text that should ordinarily be
incorporated as-is, if applicable
Note that the table of contents is automatically included, so do
not change the content or formatting of the headings. Be sure to
right click on the table of contents and select “Update field”
before saving the protocol and uploading it to Moodle. As
always, make sure to proofread the document before
submission.
Please make sure to complete the header on this page with the
protocol title and version number and date.
The submitted protocol should have no red or blue text
(including the header and instruction boxes like this one). The
submitted protocol should have no spelling or grammar errors.
All references MUST be in APA 7 format. PROTOCOL
TITLEProtocol Version Number: CompleteProtocol Version
Date: day, month, year [Include if there is an external funder;
otherwise, delete heading] Funding Mechanism: organization
and grant or contract #[Include if there is industry support;
otherwise, delete heading] Industry Support provided by: name
of industryPrincipal Investigator: name Phone: Complete E-
mail: Complete[Include if the study has a medical monitor;
otherwise, delete heading] Medical Monitor: name
Table of Contents
1List of Abbreviations4
2Protocol Summary4
3Background/Rationale & Purpose5
3.1Background Information5
3.2Rationale and Purpose5
4Objectives5
4.1Study Objectives5
4.2Study Outcome Measures6
3. 4.2.1Primary Outcome Measures6
4.2.2Secondary Outcome Measures6
5Study Design6
6Potential Risks and Benefits7
6.1Risks7
6.2Potential Benefits8
6.3Analysis of Risks in Relation to Benefits8
7Study Subject Selection8
7.1Subject Inclusion Criteria8
7.2Subject Exclusion Criteria8
7.3Recruitment Methods9
7.4Compensation for Participation in Research Activities9
7.5Withdrawal of Participants9
8Study Intervention9
9Study Procedures10
10Assessment of Safety and Data Safety Monitoring Plan
(DSMP)10
10.1Definitions10
10.2Safety Review11
10.3Reporting Plans12
10.4Stopping Rules12
11Data Handling and Record Keeping12
11.1Confidentiality12
11.2Source Documents13
11.3Case Report Forms13
11.4Study Records Retention14
12Statistical Plan14
12.1Study Hypotheses14
12.2Sample Size Determination14
12.3Statistical Methods15
13Ethics/Protection of Human Subjects15
14Literature References15
15Appendix15
List of Abbreviations
[Complete this table with all disease or study-specific
4. abbreviations/acronyms. Add rows as needed]
Abbreviation
Abbreviation definition
Protocol Summary
Limit to 1-2 pages
Title:
Study title.
Population:
Study population, sample size, sex, age, vulnerable populations
if any.
Indicate
Special Population(s)
|_|Children
|_| Children who are wards of the state
|_| Adults Unable to Consent
|_| Cognitively Impaired Adults
|_| Neonates of Uncertain Viability
|_| Pregnant Women
|_| Prisoners (or other detained/paroled individuals)
|_| Students/Employees
Intervention:
For drugs: name, dose, route of administration, regimen
(Drug/Device Handling: If the research involves drugs or
devices, describe your plans to store, handle, and administer
those drugs or devices so that they will be used only on
participants and be used only by authorized investigators.); for
other interventions: name, method, timing. (Provide a
description of all research procedures being performed and
when they are performed, including procedures being performed
5. to monitor participants for safety or minimize risks.)
(Describe:
· Procedures performed to lessen the probability or magnitude
of risks.
· Delineate which procedures are considered standard of care
and which are considered research-related. (For example, if the
frequency of CT scans is within standard of care, this should be
indicated)
· All drugs and devices used in the research and the purpose of
their use, and their regulatory approval status.
· The source records, including medical or educational records
that will be used to collect data about participants. (Attach all
surveys, scripts, and data collection forms.)
Objectives:
Study objectives.
Design/Methodology:
Study arms, randomization, schedule of interventions and
assessments. You may refer to a detailed schematic and/or table
of visits and assessments in the Appendix.
Total Study Duration:
Time from when the study opens to enrollment until completion
of data analysis
Subject Participation Duration:
Time it will take to conduct the study for each individual
participant.
Background/Rationale & Purpose
Background Information
Include as appropriate:
· A brief description of the health condition or research
question that the study will address
· The name and description of the study
intervention/investigational product
· Discussion of important research and literature and current
practice that provides background and scientific justification for
6. the study and applicable clinical, epidemiological, or public
health background or context of the study (ALL REFERENCES
MUST BE IN APA 7 FORMAT)
· Known risks and potential benefits (briefly, these are
addressed in detail later in the protocol)
· Importance of the study and any relevant treatment issues or
controversies
· Any pertinent pre-clinical data and prior experience with
intervention
[This statement is required] This study will be conducted in
compliance with the protocol, applicable regulatory
requirements, and Human Research Protection policies and
procedures.
Rationale and Purpose
Describe why it makes sense to do this study and the
importance/value of the information to be gained. Describe what
is innovative or new and useful about the potential solutions
including any new and enabling ideas or technologies, new
approaches, unique resources developed or that will be
accessed. Provide justification for the proposed use of the
intervention in this manner and within the study population.
Objectives
Study Objectives
Provide a detailed description of the one primary objective and
any secondary objectives of the study. An objective is the
reason for performing the study in terms of the scientific
question to be answered. The primary objective is the main
question. This objective generally drives statistical planning for
the research (e.g., calculation of the sample size to provide the
appropriate power for statistical testing). Secondary objectives
are goals that will provide further information on the use of the
intervention.
7. Express each objective as a statement of purpose (e.g., to
assess, to determine, to compare, to evaluate).
Study Outcome Measures
The sections below should include the methods for assessing
how the objectives are met.
An outcome measure is a specific measurement or observation
used to assess the effect of the study intervention. Outcome
measures should be prioritized and should correspond to the
study objectives and hypotheses being tested. Give succinct but
precise definitions of the outcome measures used to address the
study’s primary objective and key secondary objectives (e.g.,
specific laboratory tests that define safety or efficacy, clinical
assessments of disease status, assessments of psychological
characteristics, assessments of individual or group health
behaviors, assessments of healthcare visit attendance, etc.).
Include the study visits or time points at which data will be
recorded or samples will be obtained.
Primary Outcome Measures
Generally, there should be just one primary outcome measure
that will provide a clinically relevant, valid, and reliable
measure of the primary objective.
Secondary Outcome Measures
List additional outcome measures.
Study Design
The scientific integrity of the research and the credibility of the
data derived from the research depend substantially on the
research design. This section should include, as applicable (but
8. not be limited to):
A brief description of the type/design of research to be
conducted (e.g., randomized, placebo-controlled, masking,
parallel group, matching, cross-over, open-label, dose-
escalation, dose-ranging)
A description of the randomization process if applicable
A description of the study population (e.g., healthy/sick,
inpatient/outpatient, demographic groups). Do not list detailed
inclusion/exclusion criteria here, as these will be listed in later
sections.
A brief discussion of the rationale for design features
Phase of trial, if applicable
The number of study groups/arms and descriptions
Planned variation in intervention, dose, or schedule (e.g., dose
escalation)
A brief summary of methods for collecting data for assessment
of study objectives
Audio/Video Recording/Photography: If applicable, describe:
· the type of recording/photography being utilized
· why the type of recording is necessary to the research
· how the recordings/photograph(s) will be utilized in the
research (e.g., data analysis only)
· how and where the recordings/photograph(s) are stored, who
has access to them, and if/when they will be destroyed.)
Other protocol-specific details, such as centralization of
evaluations (e.g., central laboratory or central reading center for
clinical scans)
[Include if a schematic of the study design is in the Appendix;
otherwise, delete sentence] See the Appendix for a schematic of
the study design.
Potential Risks and Benefits
Risks
Describe in detail any reasonably foreseeable physical,
psychological, social, legal, economic, or any other anticipated
9. risks to study subjects. Include risks of study intervention and
other study procedures. Describe procedures to minimize risks.
If applicable, indicate:
· which procedures may have risks to the participants that are
currently unforeseeable.
· which procedures may have risks to an embryo or fetus should
the participant be or become pregnant.
· risks to others who are not participants.)
One or more of the following may serve as the source of risk
information:
Package insert for a licensed product
Investigator’s Brochure (IB) for an investigational product
Preclinical data reports
Literature search and review (cite references and list them in
Section 14)
Provisions to Monitor the Data to Ensure the Safety of
Participants
(This section is required when research involves more than
Minimal Risk to participants.)
Describe:
· The plan to periodically evaluate the data collected regarding
both harms and benefits to determine whether participants
remain safe. The plan might include establishing a data
monitoring committee (DSMB/DMC/IDMC) and a plan for
reporting data monitoring committee findings to the IRB and the
sponsor.
· The frequency of DSMB Meeting.
· What data are reviewed, including safety data, untoward
events, and efficacy data.
· How the safety information will be collected (e.g., with case
report forms, at study visits, by telephone calls with
participants).
· The frequency of data collection, including when safety data
collection starts.
10. · Who will review the data.
· The frequency or periodicity of review of cumulative data.
· The statistical tests for analyzing the safety data to determine
whether harm is occurring.
· Any conditions that trigger an immediate suspension of the
research.)
Compensation for Research-Related Injury
(If the research involves more than Minimal Risk to
participants, describe the available compensation in the event of
research-related injury.)
· (Provide a copy of contract language, if any, relevant to
compensation for research-related injury.)
Potential Benefits
If the research is beneficial, describe any physical,
psychological, social, legal, or any other anticipated benefits to
subjects. While it may not provide direct benefit to subjects, the
importance of the knowledge that may result from the study may
be mentioned. Note: Compensation to subjects is not considered
a “benefit.” Analysis of Risks in Relation to Benefits
Describe how risks to subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and the importance of
the knowledge that may reasonably be expected to result.
Study Subject Selection
Subject Inclusion Criteria
In order to be eligible to participate in this study, an individual
must meet all of the following criteria:
· Inclusion criteria
· Describe:
· how individuals will be screened for eligibility,
· the criteria that define who will be included or excluded in
11. your final study sample,
· specify if you will include or exclude each of the following
special populations (members of the populations below may not
be included in your research unless you indicate this in your
inclusion criteria):
· Adults unable to consent
· Individuals who are not yet adults (infants, children,
teenagers)
· Pregnant women
· Prisoners
· Vulnerable Populations
If the research involves individuals who are vulnerable to
coercion or undue influence, describe additional safeguards
included to protect their rights and welfare.
If the research involves non-English speaking participants
indicate what language(s) other than English are understood by
prospective participants or representatives. If participants who
do not speak English will be enrolled, describe the process to
ensure that the oral and written information provided to those
participants will be in that language. Indicate the language that
will be used by those obtaining consent.
Subject Exclusion Criteria
An individual who meets any of the following criteria will be
excluded from participation in this study:
· Exclusion criteria; do not duplicate what is already listed in
the Inclusion criteria above; if no additional criteria, say
“None.”
· If this study excludes certain populations, explain the
rationale for the exclusion in detail.
Recruitment Methods
Describe when, where, and how potential participants will be
recruited including the source of participants and any methods
that will be used to identify potential participants.
12. Describe materials that will be used to recruit participants.
(Attach copies of these documents in the appendix of the
application. For advertisements, attach the final copy of printed
advertisements.
When advertisements are taped for broadcast, attach the final
audio/video file. You may submit the wording of the
advertisement prior to taping to preclude re-taping because of
inappropriate wording, provided the IRB reviews the final
audio/video file.
Compensation for Participation in Research Activities
Describe the amount, timing, and method of any payments to
participants. (e.g., gift card, meals, check.)
If payment is by check, you must request name, address and
Social Security Number in order to issue a check for
participation. Study payments are considered taxable income
and are reportable to the IRS.
If the investigator believes that the biologic specimens obtained
could be part of or lead to the development of a commercial
product, indicate if the participant will have any right to
compensation or ownership interest related to such
development.
Describe when and how participants will be informed of the
results of the research.
Withdrawal of Participants
Describe:
· any anticipated circumstances under which participants will be
withdrawn from the research without their consent,
· any procedures for orderly termination,
· procedures that will be followed when participants withdraw
from the research, including partial withdrawal from procedures
13. with continued data collection.
Study Intervention
The study intervention may involve an investigational drug or
device, an approved drug or device, a behavioral intervention,
and/or a surgical or other intervention. Provide a detailed
description of the intervention, including any placebo or other
control interventions.
If the study is testing drug/biologic(s) include the following:
How the study product will be acquired
The formulation, packaging, and labeling of the product as
supplied
Product distribution, storage and stability
Dosage, preparation, and administration
Instructions for modification of dose due to toxicity or other
reason.
Accountability procedures and compliance assessment
Study Procedures
[Include; a schedule of events that lists all visits/contacts and
procedures at each visit/contact must be included in the
Appendix] See the Appendix for the schedule of events.
Include a description of all study visits and all other contacts,
such as telephone and/or email/text contacts. Include visit
windows, considering feasibility and relevance of the time point
to study outcome measures (e.g., pharmacokinetic studies may
allow little or no variation, with required time points measured
in minutes or hours, whereas a 6-month follow-up visit might
have a window of several weeks).
Describe evaluations/procedures necessary to assess or confirm
whether a subject will meet eligibility criteria and may be
enrolled. Describe in detail all tests and procedures at follow -up
visits. Include a table that lists visits and procedures at each
14. visit. Describe the final study visit as well as an early
termination visit, as necessary.
Include the total study duration (anticipated time between the
beginning of study activities to the completion of data analysis)
and the subject participation duration (the time between
enrollment and the end of study activities for an individual
subject).
Describe all clinical and laboratory evaluations. Make sure to
clarify as needed which procedures would happen anyway, if the
subject were not in the research, and which procedures are
happening due to the research. Any special handling,
processing, or shipping of laboratory specimens should be
described, including long-term storage for research purposes.
As appropriate, describe intervention-assignment procedures,
randomization procedures, and reasons subjects may be
withdrawn from the study without their consent. Describe any
procedures necessary in the case of early termination or
withdrawal of subjects.
If the study is blinded, describe procedures for masking
procedures, maintaining the blinding and procedures for
unblinding study intervention for a particular subject due to
safety reasons.
Assessment of Safety and Data Safety Monitoring Plan (DSMP)
Definitions
[Edit if necessary to make these definitions specific to the
study. Non-medical studies will require editing of the definition
of Adverse Event. If a Medical Campus PI is also the FDA
sponsor FDA definitions should be used. Include any specific
provisions for pregnancy in female subjects and/or in female
partners of male subjects.]
The following definitions will be used in the assessment of
15. safety:
Adverse Event (AE)is any untoward or unfavorable medical
occurrence in a human subject, including any abnormal sign (for
example, abnormal physical exam or laboratory finding),
symptom, or disease, temporally associated with the subject’s
participation in the research, whether or not considered related
to the subject’s participation in the research.
Serious Adverse Event (SAE) is any adverse event that
(1) results in death;
(2) is life-threatening;
(3) results in inpatient hospitalization or prolongation of
existing hospitalization;
(4) results in a persistent or significant disability/incapacity;
(5) results in a congenital anomaly/birth defect; or
(6) based upon appropriate medical judgment, may jeopardize
the subject's health and may require medical or surgical
intervention to prevent one of the other outcomes listed in this
definition (examples of such events include allergic
bronchospasm requiring intensive treatment in the emergency
room or at home, blood dyscrasias or convulsions that do not
result in inpatient hospitalization, or the development of drug
dependency or drug abuse).
Life-threatening means that the event places the subject at
immediate risk of death from the event as it occurred.
Unanticipated Problemis defined as an event, experience or
outcome that meets all three of the following criteria:
· is unexpected; AND
· is related or possibly related to participation in the research;
AND
· suggests that the research places subjects or others at a greater
risk of harm (including physical, psychological, economic, or
social harm) than was previously known or recognized.
16. Possibly related means there is a reasonable possibility that the
incident, experience, or outcome may have been caused by the
procedures involved in the research
Unexpected means the nature, severity, or frequency of the
event is not consistent with either:
· the known or foreseeable risk of adverse events associated
with the procedures involved in the research that are described
in (a) the protocol–related documents, such as the IRB-approved
research protocol, any applicable investigator brochure, and the
current IRB-approved informed consent document, and (b) other
relevant sources of information, such as product labeling and
package inserts; or
· the expected natural progression of any underlying disease,
disorder, or condition of the subject(s) experiencing the adverse
event and the subject’s predisposing risk factor profile for the
adverse event.
Safety Review
Both the risks listed in Section 4.1 and unknown risks will be
monitored as follows: a description of what risks will be
monitored, by whom, and how often; how Adverse Events will
be evaluated for severity, seriousness, relatedness, and
expectedness; how events that are not Adverse Events will be
assessed for expectedness, relatedness, and suggesting new
risks; when and how aggregate Adverse Events will be
evaluated to determine whether there are trends that could affect
subject safety; and when and how the blind may be broken to
assess events/outcomes by study arm. If there is an independent
monitoring committee (such as a Data Safety Monitoring
Board), you MUST also include a charter document as an
appendix that describes the purposes and specific functions and
processes of the safety monitoring entity.
Reporting Plans
17. The Principal Investigator will report Unanticipated Problems,
safety monitors’ reports, and Adverse Events to the IRB in
accordance with IRB policies:
· Unanticipated Problems involving a fatal or life-threatening
event will be reported to the IRB within 2 days of the
investigator learning of the event.
· Unanticipated Problems not involving a fatal or life-
threatening event will be reported to the IRB within 7 days of
the investigator learning of the event.
· Reports from safety monitors with recommended changes will
be reported to the IRB within 7 days of the investigator
receiving the report.
· Adverse Events (including Serious Adverse Events) will be
reported in summary at the time of continuing review, along
with a statement that the pattern of adverse events, in total,
does not suggest that the research places subjects or others at a
greater risk of harm than was previously known.
· Reports from safety monitors with no recommended changes
will be reported to the IRB at the time of continuing review.
[Include if there is one or more safety monitoring entity;
otherwise, delete paragraph] The Principal Investigator will
report Unanticipated Problems and Adverse Events to name of
entity; schedule of reporting requirements
[Include if there is one or more safety monitoring entity;
otherwise, delete paragraph] Name of entity will communicate
its reports and recommendations as follows: schedule of
reporting by the safety monitoring entity to the PI, IRB, and/or
sponsor.
Stopping Rules
[Include if the study has no stopping rules; otherwise, omit
sentence] The study has no stopping rules.
[Include if the study does have stopping rules; otherwise, omit
paragraphs] A subject will be withdrawn from the study if
18. adverse event(s) requiring subject withdrawal.
The study will be stopped if rules for stopping for safety,
futility, etc.
Data Handling and Record Keeping
Confidentiality
Include
· procedures for maintaining subject confidentiality for data
and/or biospecimens (e.g., training, authorization of access,
password protection, encryption, physical controls, certificates
of confidentiality, and separation of identifiers and data) during
storage, use, and transmission.
· any special data security requirements
· If data or specimens will be stored, describe
· where the specimens will be stored,
· how long they will be stored,
· how the specimens will be accessed,
· who will have access to the specimens, and
· the data to be stored or associated with each specimen
· any plans for sharing data and/or biospecimens, identified or
de-identified
· Describe the procedures to release data or specimens,
including: the process to request a release, approvals required
for release, who can obtain data or specimens, and the data to
be provided with specimens.
· any plans for registering and updating on ClinicalTrials.gov.
[Include if the study has an external sponsor, modified as
applicable; otherwise, delete] The study monitor or other
authorized representatives of the sponsor may inspect all
documents and records required to be maintained by the
investigator, including but not limited to, medical records
(office, clinic, or hospital) and pharmacy records for the
subjects in this study. The clinical study site will permit access
to such records.
19. Source Documents
Describe source data and source documents. Source data is all
information, original records of findings, observations, or other
activities in research necessary for the reconstruction and
evaluation of the research. Source data are contained in source
documents. Examples of these original documents, and data
records include: hospital records, clinical and office charts,
laboratory notes, memoranda, subjects’ diaries or evaluation
checklists, pharmacy dispensing records, recorded data from
automated instruments, copies or transcriptions certified after
verification as being accurate and complete, microfiches,
photographic negatives, microfilm or magnetic media, x-rays,
subject files, and records kept at the pharmacy, at the
laboratories, and at medico-technical departments involved in
the research.
Procedures should ensure that source data meet the “ALCOA”
standards: Attributable, Legible, Contemporaneous, Original,
and Accurate.
[Include and modify as applicable] Data generated by the
methods described in the protocol will be recorded in the
subjects' medical records and/or study progress notes. Data may
be transcribed legibly on CRFs supplied for each subject or
directly inputted into an electronic system or any combination
thereof.
Case Report Forms
[Include and modify as applicable] The study case report form
(CRF) will be the primary data collection instrument for the
study. All data requested on the CRF will be recorded. All
missing data will be explained. If a space on the CRF is left
blank because the procedure was not done or the question was
not asked, “N/D” will be written. If the item is not applicable to
the individual case, “N/A” will be written. All entries will be
20. printed legibly in black ink. If any entry error has been made, to
correct such an error, a single straight line will be drawn
through the incorrect entry and the correct data will be entered
above it. All such changes will be initialed and dated. There
will be no erasures or white-out on CRFs. For clarification of
illegible or uncertain entries, the clarification will be printed
above the item, then initialed and dated. [Include if any source
data will be recorded directly on the CRF; otherwise, omit
sentence] The following source data will be recorded directly on
the CRFs: data where the CRF will be the source document.
See the Appendix for the following CRFs: list one or more CRF
by name
Study Records Retention
Summarize the record retention plan applicable to the study
(taking into account any applicable Institutional, Department,
Division or Research Center requirements). Many entities
require that study records be retained for at least seven years
after completion of the study. Many IRBs require that
documentation of informed consent of subjects be retained for
at least seven years after the study is closed, unless the IRB
waived the requirement for informed consent or documentation
of informed consent. Such records may be preserved in
hardcopy, electronic or other media form and must be accessible
for inspection and copying by authorized individuals.
If your study involves an FDA-regulated product, in addition to
record retention times based on the completion of the study, you
should add the following based on timing of FDA actions:
Drug/Biologics:
· For Investigational New Drug (IND) research, the FDA
requires that sponsors and investigators retain “records and
reports required by this part for 2 years after a marketing
application is approved for the drug; or if an application is not
21. approved for drug, until 2 years after shipment and delivery of
the drug for investigational use is discontinued and the FDA so
notified.”
Devices:
· For Investigational Device Exemption (IDE) research, the
FDA requires that sponsors and investigators maintain the
records “for a period of 2 years after the latter of the following
two dates: The date on which the investigation is terminated or
completed, or the date that the records are no longer required
for purposes of supporting a premarket approval application or a
notice of completion of a product development protocol.”
Statistical Plan
Study Hypotheses
State the formal, testable, null, and alternate hypotheses for
primary and key secondary objectives.
Sample Size Determination
Describe the statistical methods for determining the sample size
for the study. Provide information needed to validate your
calculations, and also to judge the feasibility of enrolling and
following the necessary numbers of subjects.
Statistical Methods
Summarize the overall statistical approach to the analysis of the
study. This section should contain the key elements of the
analysis plan, but should not be a reiteration of a detailed study
analysis plan. Be clear on primary as well as any applicable
secondary analyses.
Ethics/Protection of Human Subjects
This study is to be conducted according to applicable US
federal regulations and institutional policies (which are based in
federal regulations, guidance, and ICH Good Clinical Practice
guidelines).
22. This protocol and any amendments will be submitted to the IRB,
for formal approval of the study conduct. The decision of the
IRB concerning the conduct of the study will be made in writing
to the investigator. [Include if there is a separate sponsor;
otherwise, omit sentence] A copy of the initial IRB approval
letter will be provided to the sponsor before commencement of
this study.
All subjects for this study will be provided a consent form
describing this study and providing sufficient information for
subjects to make an informed decision about their participation
in this study. The consent form will be submitted with the
protocol for review and approval by the IRB. The consent of a
subject, using the IRB-approved consent form, must be obtained
before that subject is submitted to any study procedure. Consent
will be documented as required by the IRB.
Literature References
Include a list of the full citations for ALL literature referenced
in this application in APA 7 format.
A full listing of APA style guidelines can be found at:
https://apastyle.apa.org/style-grammar-
guidelines/references/examples
Appendix
Informed Consent Document (required)
Recruitment Collateral (required)
Schedule of Events (required)
As applicable:
Schematic of Study Design
Toxicity Grading Scales
DSMB Charter
Repository Instructions
23. Biosafety Precautions
Manual of Operations
Laboratory Handling
Pharmacy Manual
IXRS Manual
Case Report Forms (CRFs)
Quality Management Plan
Data Management Plan
Clinical Monitoring Plan
Endpoint Scales
Other Documents
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