This document provides an overview of a webinar on flexible study design using Oracle Clinical/RDC. The webinar demonstrates how to create a flexible study with conditional logic that enables or disables visits and forms based on entered data. Key aspects covered include defining intervals and visits, setting up rules in an enhanced DCI book to control which visits and forms are expected based on data, and examples showing how visits and forms are dynamically enabled or disabled based on the defined rules. The webinar aims to help both current and new users of Oracle Clinical/RDC understand and leverage the flexible study design capabilities.
Introduction to Oracle Clinical Overview in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Study setup_Clinical Data Management_Katalyst HLSKatalyst HLS
Introduction to Study Setup in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Clinical research and clinical data management - Ikya Globalikya global
Data management functions in clinical trials—extensive data cleaning, full query management, protocol deviation management, batch processing, as examples—have traditionally been served by stand-alone clinical data management systems (CDMS), whose input is from paper forms or from separate electronic data capture systems. Distinct electronic data capture and data management systems require data integration, with resulting timing and reconciliation issues.
Overview of Validation in Pharma_Katalyst HLSKatalyst HLS
Introduction to Validation Concepts in Pharma, Bio-Pharma, Medical Device, Cosmetics, Food, Beverages industry.
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com
Introduction to Oracle Clinical Overview in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Study setup_Clinical Data Management_Katalyst HLSKatalyst HLS
Introduction to Study Setup in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Clinical research and clinical data management - Ikya Globalikya global
Data management functions in clinical trials—extensive data cleaning, full query management, protocol deviation management, batch processing, as examples—have traditionally been served by stand-alone clinical data management systems (CDMS), whose input is from paper forms or from separate electronic data capture systems. Distinct electronic data capture and data management systems require data integration, with resulting timing and reconciliation issues.
Overview of Validation in Pharma_Katalyst HLSKatalyst HLS
Introduction to Validation Concepts in Pharma, Bio-Pharma, Medical Device, Cosmetics, Food, Beverages industry.
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield, NJ, USA 07080.
E-Mail: info@KatalystHLS.com
Introduction to Argus Event Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Data Scientist has been regarded as the sexiest job of the twenty first century. As data in every industry keeps growing the need to organize, explore, analyze, predict and summarize is insatiable. Data Science is creating new paradigms in data driven business decisions. As the field is emerging out of its infancy a wide range of skill sets are becoming an integral part of being a Data Scientist. In this talk I will discuss the different driven roles and the expertise required to be successful in them. I will highlight some of the unique challenges and rewards of working in a young and dynamic field.
Malcolm Pradhan on Pathology in Clincial Decision Support and the role of Dee...Cirdan
Pathology testing plays an important role in the management of complex patients. Pathology laboratories continue to improve the speed and accuracy of result reporting, however the clinical management of pathology remains challenging: there is well documented variation in ordering practices, slow take-up of order sets, and up to 40% of pathology tests are not reviewed by clinical staff. The inefficient clinical utilization of pathology is a significant cost, both directly and through increased patient length of stay in hospital.
One of the established ways to improve health care delivery is integrated clinical decision support (CDS). Malcolm discusses how the effective implementation of CDS for pathology results can improve clinical productivity and patient safety. Looking further ahead the challenge for health care is to develop models of care that better tailor decisions to the needs of individual patients, and technology is required to achieve this goal. He gives a high level overview of recent advances in technology, such as big data analytics and deep learning, that will be vital in creating a sustainable health care system.
First presented in CPHl Istanbul 2016. It introduces the future developments on CTMS and EDC systems for clinical trials and their effects on the research industry. Shows how technology can revolutionize the clinical research in areas like risk based monitoring, key risk indicators, machine learning and remote SDV.
Oncology Big Data: A Mirage or Oasis of Clinical Value? Michael Peters
The title of the presentation, Oncology Big Data: A Mirage or Oasis of Clinical Value, reflects what I believe the field of Oncology is challenged with on a growing basis, from a clinical and business side perspective.
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
DIRECT CARE PROJECT PART 1ASSESSMENT AND DIAGNOSISDirectioAlyciaGold776
DIRECT CARE PROJECT PART 1
ASSESSMENT AND DIAGNOSIS
Directions: Prior to completing this template, carefully review Week 2: Direct Care Part 1 directions and all rubric requirements.
Assessment of Certification, Patient Outcomes, and Leadership
1. State the clinical certification and target population that were approved by your instructor in the Week 2: Direct Care Part 1 Assessment and Diagnosis Check-In.
a. Clinical certification
PCCN
b. Target population including setting
Nurses who provide direct care to acutely ill adult patients regardless of their physical location. My current unit is a MSPCU floor.
2. Discuss why this clinical certification was selected in relationship to the selected setting.
3. Describe the criteria for selected clinical certification
a. Process to obtain clinical certification
b. Cost of application and testing
c. Requirements prior to certification
d. Examination description
e. Renewal time and process
f. Required items for renewal
4. Provide APA reference for one peer-reviewed scholarly professional nursing journal article connecting patient outcomes, clinical certification, and leadership skills. See reference criteria under directions and include Permalink.
5. Summary of article (one to two paragraphs)
6. How could patient outcomes in the selected setting be improved by certified nurses?
7. How can clinical certification impact leadership skills in the selected setting?
Problem Diagnosis Statement
Write a diagnosis based on the problem of knowledge deficit of certifications. Fill in the blanks below.
Example: Knowledge deficit r/t CNOR certification among operating room nurses (target population and setting) as manifested by wrong site surgeries (patient outcomes)
Knowledge deficit r/t __________________certification among __________(target population and setting) as manifested by ___________________(patient outcomes).
Title:
Documentation of problem based assessment of the musculoskeletal system.
Purpose of Assignment:
Learning the required components of documenting a problem based subjective and objective assessment of musculoskeletal system. Identify abnormal findings.
Course Competency:
Demonstrate physical examination skills of the skin, hair, nails, and musculoskeletal system.
Instructions:
Content: Use of three sections:
· Subjective
· Objective
· Actual or potential risk factors for the client based on the assessment findings with description or reason for selection of them.
Format:
· Standard American English (correct grammar, punctuation, etc.)
Resources:
Chapter 5: SOAP Notes: The subjective and objective portion only
Sullivan, D. D. (2012). Guide to clinical documentation. [E-Book]. Retrieved from http://ezproxy.rasmussen.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=nlebk&AN=495456&site=eds-live&ebv=EB&ppid=pp_91
Smith, L. S. (2001, September). Documentation do’s and don’ts. Nursing, 31(9), 30. Retrieved from http://e ...
Individual Success PlanCourse # DNP 830Target Practice Hours.docxcarliotwaycave
Individual Success Plan
Course # DNP 830
Target Practice Hours 50 (Based on individual hours required to total 1,000 post-baccalaureate hours. 50 are standard per course but some students require more hours based on what they transferred in. Please contact your SSA for incoming hours.)
P
R
A
C
T
I
C
E
I
M
M
E
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S
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Complete Contact Information
Learner Information
GCU
Name:
E-mail:
Phone Number:
Course Faculty Information
GCU
Name:
E-mail:
Phone Number:
Practicum Mentor Information
Practice Setting: Acute Care Hospital
Name:
E-mail:
Phone Number:
MOU Signed & Posted in Typhon under My External Documents
Yes ►
No ►
If no, is Affiliation Agreement on file? ___
Updates and Modifications to this Individual Success Plan: Always check the DC Network for updated versions of this plan for each course. Note that Practice Immersion Contracts will no longer be used. Instructions
Use this form to develop your Individual Success Plan (ISP) for each course. An individual success plan maps out what you, the DNP Learner, needs to accomplish in order to be successful in your current course and overall program of study. You will also share this with your mentor at the beginning and end of each course so that they know what you need to accomplish.
Application based learning assignments are listed in the course syllabus with a Practice Portfolio Statement requirement. This statement also serves as a reminder for you to complete a weekly corresponding Case Log in Typhon. Any independent study assignments in this course requires your collaboration with the course faculty and practice mentor early on to establish a plan for successful completion of mutually identified and agreed upon deliverables (proof of completion) and must relate to your current course objectives. Independent study assignments must be submitted to your instructor via the Individual Forum if no drop box is available.
In order for you to successfully complete and graduate from the DNP Program you must meet the following programmatic requirements: (1) completion of required practice immersion hours, (2) completion of work associated with all DNP and GCU program competencies, (3) successful defense and completion of your Direct Practice Improvement Project.
In this ISP, you will identify all of the objectives, tasks, and/or assignments relating to the programmatic requirements you need to complete by the end of this course (minimum 50 practice immersion hours are built into the curriculum for each course). Specify the dates by which you will complete each tasks and/or assignments. Your plan should include a self-assessment of how you met all applicable GCU DNP Domains & Competencies (see Appendix A). This information will be required as you enter your weekly Case Log.
ALL course assignments listing a ‘Practice Hours Portfolio’ statement must be included in the ISP and are worth and recorded here as approximately 10 hours each. Actual clock hours are recorded ...
Introduction to Argus Event Tab Screen in Pharmacovigilance or Drug Safety of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to MedDRA Coding in Drug Safety & Pharmacovigilance Process for Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Data Scientist has been regarded as the sexiest job of the twenty first century. As data in every industry keeps growing the need to organize, explore, analyze, predict and summarize is insatiable. Data Science is creating new paradigms in data driven business decisions. As the field is emerging out of its infancy a wide range of skill sets are becoming an integral part of being a Data Scientist. In this talk I will discuss the different driven roles and the expertise required to be successful in them. I will highlight some of the unique challenges and rewards of working in a young and dynamic field.
Malcolm Pradhan on Pathology in Clincial Decision Support and the role of Dee...Cirdan
Pathology testing plays an important role in the management of complex patients. Pathology laboratories continue to improve the speed and accuracy of result reporting, however the clinical management of pathology remains challenging: there is well documented variation in ordering practices, slow take-up of order sets, and up to 40% of pathology tests are not reviewed by clinical staff. The inefficient clinical utilization of pathology is a significant cost, both directly and through increased patient length of stay in hospital.
One of the established ways to improve health care delivery is integrated clinical decision support (CDS). Malcolm discusses how the effective implementation of CDS for pathology results can improve clinical productivity and patient safety. Looking further ahead the challenge for health care is to develop models of care that better tailor decisions to the needs of individual patients, and technology is required to achieve this goal. He gives a high level overview of recent advances in technology, such as big data analytics and deep learning, that will be vital in creating a sustainable health care system.
First presented in CPHl Istanbul 2016. It introduces the future developments on CTMS and EDC systems for clinical trials and their effects on the research industry. Shows how technology can revolutionize the clinical research in areas like risk based monitoring, key risk indicators, machine learning and remote SDV.
Oncology Big Data: A Mirage or Oasis of Clinical Value? Michael Peters
The title of the presentation, Oncology Big Data: A Mirage or Oasis of Clinical Value, reflects what I believe the field of Oncology is challenged with on a growing basis, from a clinical and business side perspective.
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
DIRECT CARE PROJECT PART 1ASSESSMENT AND DIAGNOSISDirectioAlyciaGold776
DIRECT CARE PROJECT PART 1
ASSESSMENT AND DIAGNOSIS
Directions: Prior to completing this template, carefully review Week 2: Direct Care Part 1 directions and all rubric requirements.
Assessment of Certification, Patient Outcomes, and Leadership
1. State the clinical certification and target population that were approved by your instructor in the Week 2: Direct Care Part 1 Assessment and Diagnosis Check-In.
a. Clinical certification
PCCN
b. Target population including setting
Nurses who provide direct care to acutely ill adult patients regardless of their physical location. My current unit is a MSPCU floor.
2. Discuss why this clinical certification was selected in relationship to the selected setting.
3. Describe the criteria for selected clinical certification
a. Process to obtain clinical certification
b. Cost of application and testing
c. Requirements prior to certification
d. Examination description
e. Renewal time and process
f. Required items for renewal
4. Provide APA reference for one peer-reviewed scholarly professional nursing journal article connecting patient outcomes, clinical certification, and leadership skills. See reference criteria under directions and include Permalink.
5. Summary of article (one to two paragraphs)
6. How could patient outcomes in the selected setting be improved by certified nurses?
7. How can clinical certification impact leadership skills in the selected setting?
Problem Diagnosis Statement
Write a diagnosis based on the problem of knowledge deficit of certifications. Fill in the blanks below.
Example: Knowledge deficit r/t CNOR certification among operating room nurses (target population and setting) as manifested by wrong site surgeries (patient outcomes)
Knowledge deficit r/t __________________certification among __________(target population and setting) as manifested by ___________________(patient outcomes).
Title:
Documentation of problem based assessment of the musculoskeletal system.
Purpose of Assignment:
Learning the required components of documenting a problem based subjective and objective assessment of musculoskeletal system. Identify abnormal findings.
Course Competency:
Demonstrate physical examination skills of the skin, hair, nails, and musculoskeletal system.
Instructions:
Content: Use of three sections:
· Subjective
· Objective
· Actual or potential risk factors for the client based on the assessment findings with description or reason for selection of them.
Format:
· Standard American English (correct grammar, punctuation, etc.)
Resources:
Chapter 5: SOAP Notes: The subjective and objective portion only
Sullivan, D. D. (2012). Guide to clinical documentation. [E-Book]. Retrieved from http://ezproxy.rasmussen.edu/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=nlebk&AN=495456&site=eds-live&ebv=EB&ppid=pp_91
Smith, L. S. (2001, September). Documentation do’s and don’ts. Nursing, 31(9), 30. Retrieved from http://e ...
Individual Success PlanCourse # DNP 830Target Practice Hours.docxcarliotwaycave
Individual Success Plan
Course # DNP 830
Target Practice Hours 50 (Based on individual hours required to total 1,000 post-baccalaureate hours. 50 are standard per course but some students require more hours based on what they transferred in. Please contact your SSA for incoming hours.)
P
R
A
C
T
I
C
E
I
M
M
E
R
S
I
O
N
Complete Contact Information
Learner Information
GCU
Name:
E-mail:
Phone Number:
Course Faculty Information
GCU
Name:
E-mail:
Phone Number:
Practicum Mentor Information
Practice Setting: Acute Care Hospital
Name:
E-mail:
Phone Number:
MOU Signed & Posted in Typhon under My External Documents
Yes ►
No ►
If no, is Affiliation Agreement on file? ___
Updates and Modifications to this Individual Success Plan: Always check the DC Network for updated versions of this plan for each course. Note that Practice Immersion Contracts will no longer be used. Instructions
Use this form to develop your Individual Success Plan (ISP) for each course. An individual success plan maps out what you, the DNP Learner, needs to accomplish in order to be successful in your current course and overall program of study. You will also share this with your mentor at the beginning and end of each course so that they know what you need to accomplish.
Application based learning assignments are listed in the course syllabus with a Practice Portfolio Statement requirement. This statement also serves as a reminder for you to complete a weekly corresponding Case Log in Typhon. Any independent study assignments in this course requires your collaboration with the course faculty and practice mentor early on to establish a plan for successful completion of mutually identified and agreed upon deliverables (proof of completion) and must relate to your current course objectives. Independent study assignments must be submitted to your instructor via the Individual Forum if no drop box is available.
In order for you to successfully complete and graduate from the DNP Program you must meet the following programmatic requirements: (1) completion of required practice immersion hours, (2) completion of work associated with all DNP and GCU program competencies, (3) successful defense and completion of your Direct Practice Improvement Project.
In this ISP, you will identify all of the objectives, tasks, and/or assignments relating to the programmatic requirements you need to complete by the end of this course (minimum 50 practice immersion hours are built into the curriculum for each course). Specify the dates by which you will complete each tasks and/or assignments. Your plan should include a self-assessment of how you met all applicable GCU DNP Domains & Competencies (see Appendix A). This information will be required as you enter your weekly Case Log.
ALL course assignments listing a ‘Practice Hours Portfolio’ statement must be included in the ISP and are worth and recorded here as approximately 10 hours each. Actual clock hours are recorded ...
Critical pathway of care,concept mapping by Velveena Mvelveenamaran
Critical pathways of care (CPCs): used as the tools for provision of care in a case management system.
It brings together all the professional groups involved in patient care
to arrive at a consensus about standards of care and expected outcomes for selected patient groups.
A presentation on the continuous improvement tool of total quality management, i.e. PDCA- Plan,Do,Check,Act. Covers the basics of PDCA to give an idea on it's need, use, methodology etc. The presentation will help the beginners gain knowledge about the PDCA cycle and will cover their basic needs on it.
Course Project Hospital Data Analysis and ReportingObjectiveTheCruzIbarra161
Course Project: Hospital Data Analysis and Reporting
Objective
The purpose of this Course Project is to apply the knowledge gained in analyzing various performance indicators of a hospital, analyzing trends, determining compliance or poor performance areas, and providing recommendations for improvement or solutions.
Guidelines
For this Course Project, you are asked to analyze a number of status reports for General Hospital, determine compliance with indicators provided to you, and provide suggestions or make recommendations for improvement where needed.
Data on the following indicators are provided in a Microsoft Excel document.
1. Release of Information Reports (ROI)
2. Record Completion: Physician Orders (PO)
3. Record Completion: History and Physical (H & P)
4. Record Completion: Discharge Summary (DC Summary)
5. Report Completion: Operative Report (OP Report)
6. Incident Reports (IR)
7. Standards
8. Rubric (grading rubric)
Part 1: Data Calculations, Standards, and Compliance Notes
Turn the General Hospital status data given for the month of January into meaningful information by performing the following.
Point Values
General Criteria
Specific Data Calculation, Standards, and Compliance Rate Components
40 points
5 points for each type of calculation listed in the last column
Calculations necessary to find completion timeliness for the following on the next column
1. Release of information for all 20 requests (how many days it took to release the information requested)
1. Physician orders (how many days it took every physician to sign each of his or her orders)
1. History and physical dictation (how many days it took to dictate the H & P for each admission—subtract date of admission from the date of dictation)
1. History and physical transcription (how many days it took to transcribe the H & P—subtract date of dictation from the date of transcription)
1. Discharge summary dictation (how many days it took to dictate the DC for each admission—subtract date of discharge from the date of dictation)
1. Discharge summary signature (how many days it took to sign the DC—subtract date of discharge from the date signed)
1. Operative report dictation (how many days it took to dictate the OP report for each admission—subtract date of surgery from the date of dictation)
1. Operative report signature (how many days it took to sign the OP report—subtract date of surgery from the date signed)
15 points
Standards* for the following on the next column
*Standards can be added in each worksheet applicable to the item being analyzed.
1. Completing ROI requests in the cases when records are on-site or off-site
1. Signing orders
1. Dictating a history and physical
1. Signing a discharge summary
1. Dictating an operative report
30 points
5 points for each of the items listed in the last column
Compliance rates based on the standards identified for the following on the next column
1. ROI requests
1. Physician orders
1. Dictation of History and Physical
1. Sig ...
Process Improvement Plan For this, your penultimate assignment .docxstilliegeorgiana
Process Improvement Plan:
For this, your penultimate assignment for this class, you’ll be putting together a process improvement plan. There’s nothing tricky about this assignment; it is nothing more or less than what its name suggests. You’ll just pick a process at use in an organization with which you’re familiar and explain how it can be improved.
There’s a document in Files with the subtitle ‘process improvement plan’ that I recommend you download and read through, since many parts of this assignment were taken from this template. Although a formal process improvement plan includes an assessment of the change after it’s been implemented, we’re going to forgo that step here. Instead, we’re going to focus on writing a rationale for the plan, developing and implementing the plan, and evaluating the plan.
The paper will be broken into five parts/sections. What follows here are the assignment guidelines, and the point value of each section:
General Guidelines:
· Label each area using the five headings included in the grading rubric.
· Use organizational charts, tables, and bulleted lists where appropriate (make sure that you label these items)
· Check for spelling and grammar errors. Two points will be taken off for each error.
· Use MS Word or save your document as a rich text file, so that formatting is retained.
· Include page numbers (this part of the project will generally be between 5-7 pages in length)
· Include a title page
· Upload your completed project into the appropriate area in Week 13.
Section 1: Introduction
Give us a brief overview of the organization that you are profiling, and explain the process that you intend to improve.
Section 2: Rationale for Change
This section is comprised of two parts, labeled below as ‘a’ and ‘b’.
a) Explain how the process you are analyzing satisfies the following criteria:
· The process can be defined. That is, we can explain in ‘plain English’ what the process is. Walk the reader through each step of the process as it’s currently conducted.
· The process occurs frequently within the organization.
· The problems with the current process are fairly well-known and obvious (HINT: It will likely be helpful here to provide examples of instances where the current process has broken down or where its inefficiency has been exposed).
· Stakeholders will appreciate improvements to this process.
· We can make the needed changes to this process with little or no outside help.
b) Additionally, provide a flowchart of the current process. Be sure to include all steps.
Section 3: Process Design and Implementation
This section is comprised of three parts, labeled ‘a’ , ‘b’ and ‘c’ below.
a) Answer the following questions. Be sure your answers are complete.
· What steps in the process will be changed?
· What are the risks associated with this change?
· What are the costs?
· What workers will be affected by this change? Discuss both those workers who will be directly affected, and those that will be indirectl ...
Meaningful and active collaboration with public and patient partners in planning, conducting and disseminating rapid reviews helps ensure that their perspectives are considered in research priorities and in shaping the evidence and care they receive.
Join us for an interactive session to learn about meaningfully engaging public partners in rapid reviews. We will present a spectrum of strategies to involve public partners and share lessons learned to optimize these opportunities. Public and patient partners will also present and share their perspectives and experiences.
A brief 1 hr talk provided at the Sydney Agile @ Scale Meetup group in October 2016 to cover the basics of Kanban and Enterprise Services Planning (ESP), talking concepts from DJA's slideshare content and adding in games for people to discover what Kanban and ESP is about.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
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2. Welcome and Introduction
Steven Rifkin
Chief Application Expert
• 15+ years of experience with
Oracle Clinical, TMS and RDC;
doing Database Design, Study
Conduct and custom
programming
3. Today’s Agenda
Time Topic
10:00-10:05 Welcome and Introduction
10:05-10:10 Who, What and Why?
10:10-10:30 Flexible Study Design Discussion
and Demonstrations
10:30-10:45 Flexible Study Setup
10:45-10:55 Q&A
10:55-11:00 Wrap-up and Contact Information
4. Who, What and Why?
• Who is the intended audience?
– Current OC/RDC users contemplating an upgrade
to version 4.6
– New users of OC/RDC 4.6 who want to learn
more about flexible study design
– Non-OC/RDC users evaluating the features of the
application who perhaps previously reviewed an
earlier OC/RDC version
5. Who, What and Why?
• What features are we examining today?
– Demonstrate a flexible study showing ability to
enable or disable entire forms or visits based on
data responses
– Setting up a Flexible Study via an Enhanced DCI
Book
6. Who, What and Why?
• Why are these features important?
– Organizations need the ability to create a study
schedule which is flexible for more complex
clinical trials
– Especially important when the sites will perform
the entry in an EDC system so that users are
presented only with the forms/visits they need
7. Flexible Study Design …
• Prior to Release 4.6, Oracle Clinical required
strict sequential navigation through a set of
Clinical Planned Events in a DCI book
• Some trials require complex (or flexible)
studies with multiple treatment arms with
different patient groups receiving different
assessments
– Common for Oncology trials
8. Flexible Study Design
• Release 4.6 allows multiple pathways to be
defined in a single DCI Book using
conditional logic based on data for a specific
patient
– Logic will make a new set of visits and CRFs
expected for the patient
• The RDC Onsite interface now has a
dynamic display of newly expected visit and
CRF data as patient data is entered
9. Example Study
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
10. Rules for Example Study
1. Until any data for Demography form is entered, only
the Screening Visit is expected; after demography
data, the Completion and AE Log visits are expected
2. The Enrollment CRF during the screening Visit will
determine and schedule the Cycle 1 visits in either
Arm A or Arm B
3. Response to a question during Interim Visit in a cycle
with schedule next cycle or end the study for subject
4. If treatment not given during any treatment visit,
subject will leave the study
5. If treatment is given, a new expected form is added
for the visit
11. Example Study: Rule 1
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Only the Screening Visit is expected until data entered on the Demography
form. Demog entry will enable the Completion Visit and the AE Log
13. Example Study: Rule 2
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Enrollment CRF specifies if Patient is in Arm A or Arm B and schedules cycle 1 treatments
15. Example Study: Rule 3
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
YES to “continue to next cycle” in any Interim Visit will schedule the next Treatment Cycle
NO to “continue to next cycle” in any Interim Visit bypass remaining cycles
17. Example Study: Rule 4
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
NO to “give treatment” in any treatment will bypass remaining visits and cycles
19. Example Study: Rule 5
YES to “should drug be given” in any treatment will
schedule a new form to be completed at the visit
HEMATOLOGY FORM
Should Drug be given?
Yes
INFUSION FORM
21. Setup of a Flexible Study
1. Identify the Study as Flexible during initial
study setup to set the Clinical Study State
2. Define Intervals and Clinical Planned
Events for the study
3. Set up “Enhanced” DCI Book with DCI
Book Rules
23. Intervals
• An Interval is a time span in which there are one or more visits
(Clinical Planned Events)
• Types of Intervals
– Phase
– Periods
– Sub-periods
Modeling the study will involve placing visits in specific Intervals
• Need to plan since visits in an interval will be enabled by logic in Flex
Study Design
Phase
Period
Sub-Period
Intervals
26. Defining Clinical Planned Events …
• Each Clinical Planned Event used in your study must be
defined and associated with an Interval (Phase, Period or
Sub-period)
• Each CPE in the study must have a unique name – use a
shorthand to indicate parent phase, period and sub-period
– Treatment 1 visit is defined in multiple intervals
• Visit for Treatment Phase, Arm A, Cycle 1 named AC1 TREATMENT 1
• Visit for Treatment Phase, Arm A, Cycle 2 named AC2 TREATMENT 1
• Visit for Treatment Phase, Arm B, Cycle 1 named BC1 TREATMENT 1
• Visit No. field reflects the sequence in the schedule and will
not reflect the actual sequence of events for a patient
• Duration fields are required but have no effect on the flexible
study definition
27. Enhanced DCI Books …
• Function for Enhanced DCI Books has four
sections
– Navigator: Display screen listing the visits
defined for the study and the interval to which
each is assigned
– Constraints: Limit the unplanned use of specific
DCIs (no change from earlier versions)
– Interval Rules: Define when an interval and its
associated visits and DCIs will become expected
– DCI Rules: Define when a specific DCI becomes
expected in a visit or over all visits
27
29. Enhanced DCI Books: Navigator …
Definition DCIs Enhanced DCI Books, [Navigator]
This column will be blank
for non-flexible studies
Select a Visit and click [DCI Book Pages for CPE]
to define which DCIs are expected for that Visit
Counts will update
dynamically as DCIs are
added to Visits and
Rules defined
CPE and Intervals are
pre-populated with
Events for the Study
30. Enhanced DCI Books: Navigator …
Definition DCIs Enhanced DCI Books, [Navigator], [DCI Book Pages for CPE]
Enter (or select with LOV) a DCI that may be
expected at this Visit
Use the buttons to
change the Visit to
which DCIs will be
assigned
31. Enhanced DCI Books: Rules
• Book Rules are available only for Flexible Studies
• Rules apply to all patients to which the book is
assigned
• Interval Rules enable an interval and the visits
within the intervals
• DCI Rules enable a specific DCI
– DCI within the current visit
or
– DCI across all visits in which the DCI is defined
• Rules determine “expectedness”
32. Enhanced DCI Books:
Interval Rules
• All Intervals are considered enabled unless a target
of an Interval Rule
• Interval Rules are specified for a specific DCI
– will apply to all visits where the DCI is entered
• Triggers at a DCI determine if an interval is
enabled
– Trigger Conditions
• Trigger an interval when any data is entered in the DCI
• Trigger an interval when there is a specified response to a
question
– Trigger Actions
• Enable one or more named target intervals
• Enable Next Interval
• Bypass to a specified target interval
33. Enhanced DCI Books: Rules
Prior to definition of any Book Rules all DCIs in all
CPEs in all intervals will appear in the RDC surround
34. Enhanced DCI Books:
Interval Rules …
Definitions DCIs Enhanced DCI Books, [Interval Rules]
RULE: Enable the Completion and Logs Intervals if any data is entered on Demography
35. Enhanced DCI Books:
Interval Rules …
Before Demography Entered:
Completion and Logs Intervals
do not appear -- they are now
Targets of Rules
36. Enhanced DCI Books:
Interval Rules …
After Demography Entered:
Completion and Logs Intervals
appear -- the Interval Rule
enables them
Treatment intervals still appear
because these are not yet targets
of an interval rule!
37. Enhanced DCI Books:
Interval Rules …
Definitions DCIs Enhanced DCI Books, [Interval Rules]
RULE: enable the “A Cycle 1” Interval or the “B Cycle 1” Interval dependent
on the Arm assigned on Enrollment DCI
38. Enhanced DCI Books:
Interval Rules …
Before Enrollment DCI is completed, no visits in either the “A Cycle 1” Interval or
the “B Cycle 1” Interval will be present because both intervals are now targets
39. Enhanced DCI Books:
Interval Rules …
When Enrollment DCI is completed, the visits in either the “A Cycle 1” Interval or
the “B Cycle 1” Interval will be added as enabled
Enrolled in A Arm
40. Enhanced DCI Books:
Interval Rules …
RULE: At last (INTERIM) visit for any cycle, if response to the NEXT_CYCLE_YN
question is NO, bypass to the COMPLETION Interval; if response is YES, then
enable the next sequential interval
41. Enhanced DCI Books:
Interval Rules …
Without DEMOGRAPHY, only Screening Interval is enabled since use of [Next Interval] at
the end of all cycles makes each treatment cycle a target of a rule
44. Enhanced DCI Books:
Interval Rules …
At INTERIM Visit for Arm A Cycle 1, specify YES to continue to next cycle --
and Arm A Cycle 2 Visits are enabled
45. Enhanced DCI Books:
Interval Rules …
At INTERIM Visit for Arm A Cycle 1, specify NO to continue to next cycle --
and Arm A Cycle 2 Visits are not enabled: bypassed other cycles
46. Enhanced DCI Books:
Interval Rules …
At INTERIM Visit for Cycle 2, specify YES to continue to next cycle --
and Arm A Cycle 3 Visits are enabled
47. Enhanced DCI Books:
Interval Rules
At AC1 Treatment 2, Dose was not given. Only Visits in the Completion and Logs
Intervals are enabled; Visits after the current visit in the current interval are disabled!
48. Enhanced DCI Books:
DCI Rules …
• Within an Interval, rules can be defined to
enable specific DCIs in the visit or across all
visits which contain that DCI
– Only DCIs which contain one or more questions
associated with a DVG can be have DCI rules
49. Enhanced DCI Books:
DCI Rules …
RULE: At a Treatment Visit, if the Dose is given (GIVE_DOSE_YN=YES) then an
infusion form must be made “expected” in that visit
50. Enhanced DCI Books:
DCI Rules
Before GIVE_DOSE_YN was completed,
no INFUSION form expected at visit
After GIVE_DOSE_YN was completed, an
INFUSION form is expected at visit!
52. Closing
Thank you for attending!
This webinar will be posted on
www.biopharm.com
within 24 hours
Contact BioPharm
United States: +1 877 654 0033
United Kingdom: +44 (0) 1865 910200
Email Address: info@biopharm.com