Clinical Knowledge Management and Tool Guide · •Storytelling, Case studies •Best Practices...

Clinical Knowledge

Management (CKM)

and Tool Guide

Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. 2

Table of Contents

I. Introduction to CKM Reference and Tool Guide

II. Instruction for Navigation

III. KM in Action — Knowledge Lifecyle

IV. TransCelerate’s CKM Framework

V. Steps for Developing & Sustaining a CKM Framework

VI. CKM Key Definitions

VII. General CKM Resources and Selected Publications


Introduction to the CKM Reference and Tool Guide

This Guide has been created to help clinical development organizations, whether

a team, department or organization as a whole, recognize what types of tools and

resources are available and would potentially be useful in the development,

maintenance and continuous improvement of a Clinical Knowledge

Management (CKM) strategy and program.

The Guide provides brief, high-level descriptions of Knowledge Management (KM)

tools with references to practical applications. This tool also provides a list of

selected, general resources such as KM websites, professional associations &

publications, that might help with KM implementation.

It is intended to be used as an initial resource and reference to help increase level

of CKM understanding and is snot intended to represent the ultimate source of

CKM knowledge resources nor as a “how to” guide for use of the suggested tools.


To help users determine what types of CMK tools or

resources would be applicable during the various

stages of a CKM Program lifecycle, the search

function is structured based on visual aids which can

be navigated via different views as described in the

TransCelerate Manuscript:

Note that similar types of KM

tools may appear when the user

selects different combinations of

categories during a search. This

Reference and Tool Guide does

not describe specific CKM tools

developed by the TransCelerate

CKM workstream.

Before using the CKM Reference

Tool Guide it is important that

you have read the TransCelerate

CKM manuscript. This will help in

the interpretation of the search

results and their possible purpose.

Introduction to the CKM Reference and Tool Guide

Tools and resources developed by TransCelerate can be found at:

http://www.transceleratebiopharmainc.com/i

nitiatives/quality-management-system/

Link to the sharepoint where member

companies can access other tools

KM In Action – Knowledge

Lifecycle

CKM Framework

Steps For Development of a CKM Program

http://journals.sagepub.com/stoken/rbtfl/cWeGaiCoiCBfZkd/full

http://www.transceleratebiopharmainc.com/initiatives/quality-management-system/

https://transceleratebiopharma.sharepoint.com/sponsors/QMS/Forms/AllItems.aspx?RootFolder=/sponsors/QMS/Final QMS Publications, Resources and Tools/Approved Resources _Tools&FolderCTID=0x01200059644D25B14A8F479B39DF62E7991693&View=517148FD-B971-4960-82D7-FE5359076692

KM in action – Knowledge Lifecycle


KM in action – Knowledge Lifecycle

Know what knowledge exists,

where to look for it and how to quickly find it

Capture knowledge in a consistent and searchable manner

Know who the experts are and how to contact them for advice

Connect readily across boundaries of teams, functions and

geographies

Share lessons learned so new work

always starts using current best practice

IDENTIFY

CAPTURE

STRUCTURE

SHARE

LEVERAGE

VALUE


• Content Management: Document

Repositories, Portals, Wikis

• Search-enablers: Enterprise search

• Search-enablers: Faceted search

• Search-enablers: Taxonomy,

Metadata/keyword, Folksonomy

• Best Practices

• Communities of Practice, Centers

of Excellence



• Expertise Location

• KM Maturity Models

• Knowledge Mapping

• Offboarding

• Onboarding

• Storytelling, Case studies

• Best Practices


of Excellence



• Lessons Learned, After Action

Review, Milestone Review

• Offboarding

Tools for Category

• Best Practices


of Excellence






• Offboarding

• Onboarding

• Role Mentoring, Apprenticeships


• Best Practices




• Offboarding

• Onboarding


• Best Practices


of Excellence







STRUCTUREIDENTIFY CAPTURE

SHAREVALUE LEVERAGE

TransCelerate’s Clinical

Knowledge Management

Framework


KNOWLEDGE MANAGEMENT

PEOPLE BUSINESS PROCESS

CONTENT TECHNOLOGY

• KM Specific roles

• Training, teaching, mentoring

• Change management roles

• Integration of KM in business processes

• Governance

• Measurement

• Change management

• Tacit & explicit knowledge

• Taxonomy & metadata

• Templates & tools

• Data Storage

• Document repositories

• Team sites

• Networking software

• Search capabilities

CONTINUOUS IMPROVEMENT

CULTURE

• Flexibility

• Knowledge-driven learning and improvement

• Leadership commitment

• Promotes knowledge seeking and exchange

TransCelerate’s Knowledge Management Framework

Adapted from O’Dell and Hubert, 2011.


• Best Practices


of Excellence




• Offboarding

• Onboarding



• Best Practices


of Excellence




• Offboarding

• Onboarding



• Best Practices





• Offboarding


Tools for Category







• Best Practices





• Onboarding









PEOPLECULTURECONTINUOUS IMPROVEMENT

TECHNOLOGYBUSINESS PROCESS CONTENT

Steps for Development

and Sustain of a CKM

Framework


Steps for Development and Sustain of a CKM Framework

Think big, start small. And most importantly – Start!

1

34

2

Step1

Understand the

Knowledge Needs

Step 2

Assess

Opportunity

Step 3

Design and

Implement Solutions

Step 4

Improve and Sustain


1. Identify most critical information and knowledge needed by the organization

2. Understand the challenges and risks related to knowledge gaps

3. Assess KM behaviors of the organization

Step 1: Understand the Knowledge Needs

1

3

4

2Understand the Knowledge Needs Assess

Opportunity

Design and Implement Solutions

Improve and Sustain

Actions to Take:

Identify the critical knowledge

necessary to drive optimal outcomes tailored to organizational needs

Areas of critical knowledge needs in key business processes are identified for more detailed assessment in Step 2

Outcome:


1. Identify current gaps in the availability of specific knowledge needed to support key business processes

2. Prioritize opportunities based on business needs

3. Propose business case and pilot projects to relevant governance body for approval

Step 2: Assess Opportunities

1

3

4

2Understand the Knowledge Needs

Assess Opportunity


Improve and Sustain

Actions to Take:

Business case and pilot(s) are endorsed by governance body

Outcome:Understand where improvement of

knowledge flow may provide opportunity for enhanced execution to improve critical business outcomes


1. Select relevant KM approach(es) to address the types of knowledge to be managed

2. Design Clinical KM solutions/tools

3. Develop training plan and training materials

4. Communicate training and implementation plans to users

5. Deliver training to users

6. Deploy Clinical KM solutions/tools

7. Support users

8. Define measures for assessing use and effectiveness

Step 3: Design and Implement

1

3

4


Assess Opportunity


Improve and Sustain

Actions to Take:

CKM Solutions/Tools implemented with user support system in place

Outcome:

Define and deploy mechanisms to

enable and improve knowledge access and sharing


1. Establish ongoing oversight and business processes for Clinical KM Program maintenance and improvement

2. Update and/or expand Clinical KM Strategy and Program based on evolving business needs

3. Define and implement business-related measures for assessment of Clinical KM performance

4. Develop approaches for reinforcement and recognition of Clinical KM successes

Step 4: Improve and Sustain

1

3

4


Assess Opportunity


Improve and Sustain

Actions to Take:

CKM Program and Strategy established with mechanisms in place for ongoing oversight and feedback on performance

Outcome:

Assess performance against

anticipated outcomes and adjust as necessary. Assess opportunities for continuous improvement to sustain the framework over time.




• Lessons Learned, After Action Review, Milestone Review

• Offboarding

• Onboarding




• Offboarding

• Onboarding

Tools for Category

• Best Practices

• Communities of Practice, Centers of Excellence

• Content Management: Document Repositories, Portals,

Wikis




• Offboarding

• Onboarding




• Search-enablers: Taxonomy, Metadata/keyword,

Folksonomy

• Best Practices

• Communities of Practice, Centers of Excellence

• Content Management: Document Repositories, Portals,

Wikis




• Offboarding

• Onboarding



1. UNDERSTAND THE KNOWLEDGE NEEDS 2. ASSESS OPPORTUNITY

3. DESIGN AND IMPLEMENT SOLUTIONS 4. IMPROVE AND SUSTAIN

Tool Descriptions


Description:

Methods or techniques that have been generally accepted as superior to any

alternatives because they produce superior results and/or have become the

standard way of doing things. Use of best practices, which are continually

improved through experience and lessons learned, drives consistency in

execution within an organization and improves productivity and efficiency. A

commitment to using the best practices in any field is a commitment to using

all the existing knowledge and technology at one's disposal to ensure success.

References:

As best practices vary and depend on each individual company's circumstances and stage of maturity, no references are provided

Best Practices


Description:

Groups of interested individuals come together (face-to-face or virtually) to

share a common area of expertise, search for solutions to common problems,

and/or learn from one another. Facilitate the flow of knowledge across

boundaries in geography, function, team, etc. Each community is centered

around a topic of importance to the business, particularly where expertise is

not widely available.

References:

Hasanali F, Hubert C, Lopez K, Newhouse B, O'Dell C, Vestal W. APQC's Passport to Success Series. Communities of Practice. 2002. http://www.citeulike.org/group/382/article/303117

Wenger E, Snyder W. Communities of Practice: The New Organizational Frontier. Harvard Business Review. January-February 2000; 78 (1): 139-145.https://hbr.org/2000/01/communities-of-practice-the-organizational-frontier

Communities of Practice, Centers of Excellence

http://www.citeulike.org/group/382/article/303117

https://hbr.org/2000/01/communities-of-practice-the-organizational-frontier


Description:

Identify experts in specific areas and make it easy for employees to find them,

regardless of geographic and departmental boundaries. Possible approaches

include on-line directories, searchable profiles, social networking, mining of e-

mail topic frequency, scientific publications & patents, etc.

References:

The Intersection of Content Delivery, Expertise Location, and Social Collaboration. APQC. May 11, 2015. https://www.apqc.org/search/apachesolr_search/APQC%20Explores%20the%20Intersection%20of%20Content%20Delivery%2C%20Expertise%20Location%2C%20and%20Social%20Collaboration

Expert Location

https://www.apqc.org/search/apachesolr_search/APQC Explores the Intersection of Content Delivery, Expertise Location, and Social Collaboration


Description:

One-stop-shopping for content that provides single authoritative instance of a

file (vs. duplicate files with different versions in multiple locations); access to a

central repository (vs. proliferation of storage repositories ); and enables search

by standardizing the naming conventions for similar content. The lifecycle of

document repositories/portals includes:

• Author – creation & updating, version control

• Review – validation/vetting of content & placement

• Administration – controlled access (permissions), standardization rules, archiving

• User – receives alerts for new content & changes to existing

References:

Enterprise Content Management. Enablers of Effectiveness. APQC. August 26, 2014. https://www.apqc.org/search/apachesolr_search/Enterprise%20Content%20Management.%20Enablers%20of%20Effectiveness

Content Management: Document Repositories, Portals, Wikis

https://www.apqc.org/search/apachesolr_search/Enterprise Content Management. Enablers of Effectiveness


Description:

An assessment of knowledge management capability levels across multiple

dimensions that provides a measurement of KM program status versus a

maturity scale. Evaluates the gaps/areas for improvement and capabilities

that need to be focused on to achieve goals. Provides a framework to

measure the progress of a KM program against an external benchmark and

helps determine next steps toward reaching the desired maturity level.

References:

KM Maturity Models

How Mature is Your KM Program? Using

APQC’s KM Capability Assessment Tool.

APQC. August 29, 2011.

https://www.apqc.org/search/apachesolr_

search/How%20Mature%20is%20Your%20K

M%20Program%3F%20Using%20APQC%E2%

80%99s%20KM%20Capability%20Assessment

%20Tool

Khatibian N, Hasan gholoi pour T and Jafari

HA. Measurement of knowledge

management maturity level within

organizations. Business Strategy Series. 2010;

11(1):54-70.

https://www.researchgate.net/publication/

240259735_Measurement_of_knowledge_m

anagement_maturity_level_within_organiza

tions

Fabio Lotti O. Knowledge management

barriers, practices and maturity model.

Journal of Knowledge Management. 2014;

18(6):1053-1074.

https://www.researchgate.net/publication/

280172007_Knowledge_management_barri

ers_practices_and_maturity_model

Pee LG and Kankanhalli A. A Model of

Organisational Knowledge Management

Maturity Based on People, Process, and

Technology. Journal of Information &

Knowledge Management. 2009; 8: 90.

http://www.worldscientific.com/action/doS

earch?pubType=specific&AllField=A+Mode

l+of+Organisational+Knowledge+Manage

ment+Maturity+Based+on+People%2C+Pro

cess%2C+and+Technology&publication=

Tissayakorn K, Akagi F and Song Y. A Model

of Organization Knowledge Management

Maturity. International Journal of

Bioscience, Biochemistry and

Bioinformatics. 2013; 3: 616-617.

http://www.ijbbb.org/papers/287-

A30008.pdf

https://www.apqc.org/search/apachesolr_search/How Mature is Your KM Program? Using APQC%E2%80%99s KM Capability Assessment Tool

https://www.researchgate.net/publication/240259735_Measurement_of_knowledge_management_maturity_level_within_organizations

https://www.researchgate.net/publication/280172007_Knowledge_management_barriers_practices_and_maturity_model

http://www.worldscientific.com/action/doSearch?pubType=specific&AllField=A+Model+of+Organisational+Knowledge+Management+Maturity+Based+on+People,+Process,+and+Technology&publication=

http://www.ijbbb.org/papers/287-A30008.pdf


Description:

A knowledge map identifies business-critical knowledge, sources, flows, gaps,

barriers and dependencies using a visual representation of the knowledge of

an organization or underlying a business process. Evaluate the knowledge flow,

quality and business impact. Also useful for new employee training & personnel

changes.

References:

Complete Knowledge Maps to Identify Knowledge Gaps and Needs. APQC. January 25, 2016. https://www.apqc.org/search/apachesolr_search/Complete%20Knowledge%20Maps%20to%20Identify%20Knowledge%20Gaps%20and%20Needs

Knowledge Mapping 101. Knowledge for Development Seminar 09/22/03 materials. USAID, September 2003, PN-ADK-308 http://pdf.usaid.gov/pdf_docs/Pnadk308.pdf

Knowledge Mapping

https://www.apqc.org/search/apachesolr_search/Complete Knowledge Maps to Identify Knowledge Gaps and Needs

http://pdf.usaid.gov/pdf_docs/Pnadk308.pdf


Description:

Employees formally discuss, capture and share what they learned at

established points or upon completion/resolution of a project or issue.

A narrative account of an actual experience includes:

• Context: What was expected to happen?

• Facts: What actually happened?

• Root Cause Analysis: Why were there differences?

• Recommendations: What can be learned? Where else is this applicable?

A lesson can highlight positive or negative experiences, reinforce standard

procedures, or inform best practices. A lesson is not "learned" until it results in a

change in behavior and that change produces the predicted results.

References:

After-Action Review Technical Guidance. USAID, February 2006, PN-ADF-360 http://pdf.usaid.gov/pdf_docs/PNADF360.pdf

Lessons Learned, After Action Review, Milestone Review

http://pdf.usaid.gov/pdf_docs/PNADF360.pdf


Description:

A process of capturing the explicit and tacit knowledge held by

selected/experienced employees or experts in their field with critical

knowledge not captured elsewhere, who are transitioning out of an

organization. Develop strategies to successfully transfer the knowledge

focusing on how they approach, analyze and solve problems. Offboarding

process includes project wrap-ups, sharing and extracting the knowledge from

a departing employee. Some approaches include make a plan, motivate the

expert, create apprenticeships, emphasize team learning, document

selectively, focus on the relationship, create offboarding checklist, etc.

References:

Knight R. The Right Way to Off-board a Departing Employee.

Harvard Business Review. January 2016.

https://hbr.org/2016/01/the-right-way-to-off-board-a-

departing-employee

Dashe & Thomson. How To Extract Knowledge From Experts

Before It's Lost. July 10, 2014.

http://www.dashe.com/blog/learning/retain-institutional-

knowledge-experts/

Offboarding

https://hbr.org/2016/01/the-right-way-to-off-board-a-departing-employee

http://www.dashe.com/blog/learning/retain-institutional-knowledge-experts/


Description:

The process through which new employees acquire the necessary baseline

knowledge, skills, and behaviors to become effective within the organization.

Common approaches used in this process include formal meetings, lectures,

videos, printed materials, or computer-based orientations to introduce

newcomers to their new jobs, organizations and culture.

References:

https://en.wikipedia.org/wiki/Onboarding

Onboarding

https://en.wikipedia.org/wiki/Onboarding


Description:

Transfer of knowledge from experienced to newer employees with the goal of

shortening time to competency and improving learning curves.

References:

Workplace Mentoring: Study Overview. APQC. April 21, 2016. https://www.apqc.org/search/apachesolr_search/Workplace%20Mentoring%3A%20%20Study%20Overview

Role Mentoring, Apprenticeships

https://www.apqc.org/search/apachesolr_search/Workplace Mentoring: Study Overview


Description:

Stories make abstract concepts concrete, easier to understand, and

demonstrate best practices and/or lessons learned, including how KM

practices can be applied plus the resulting benefits. This approach helps to

bridge generational gaps and communicate important information about an

organization. It also helps to foster engagement in a KM program and illustrate

cultural behaviors that enable KM.

References:

Snowden D. Storytelling: An Old Skill in a New Context. Business Information Review. March 1999: 30-37. http://bir.sagepub.com/content/16/1/30.abstract

Storytelling, Case Studies

http://bir.sagepub.com/content/16/1/30.abstract


Description:

Enterprise Search: Single unified interface with capability to search multiple

data sources in both intranet and internet, and provide results based on high

relevance and semantic knowledge. Search queries and results can be shared

and re-used. Limitations include return of results only from storage repositories

to which the user has access and the content is not always reviewed or

validated.

References:

As these are designed individually to address the needs of each organization, no references are provided

Search-enablers: Enterprise Search


Description:

Faceted Search: information classification structure consisting of a series of

"facets" or dimensions according to which objects can be categorized, such as

by location or subject.

Each facet is typically defined by a taxonomy. An item is classified by selecting

the appropriate term from each relevant facet taxonomy. Commonly

constructed as an aid for organizing and finding information. It can be used as

a guide to Web-site navigation and search. It has more power than a single

taxonomy because it supports different ways of classifying information. Multi-

faceted navigation reflects the different perspectives of end-users. An

illustrative example of search for study protocol dimensions: document

type=protocol; therapeutic area; product; study phase; etc.

References:

As these are designed individually to address the needs of each organization, no references are provided

Search-enablers: Faceted Search


Description:

Word(s) that describe a given knowledge item are often used to find it within a

content management system. Taxonomy categorizes knowledge under

consistent headings that enable search using the heading name. Additional

detail that can be used in searching is provided by metadata: keywords that

further describe specific knowledge items. Folksonomies may also be used

through user generated tags.

References:

Walli B. Taxonomy 101: The Basics and Getting Started with

Taxonomies. KM World. August 15, 2014. Based on the report by

Faulkner Information Services. 2014.

http://www.kmworld.com/Articles/Editorial/What-Is-

.../Taxonomy-101-The-Basics-and-Getting-Started-with-

Taxonomies-98787.aspx

Earl MJ. Knowledge Management Strategies: Toward a

Taxonomy. Journal of Management Information Systems.

Summer 2001, Vol. 18, No.1, pp. 215-233

http://www.cs.nott.ac.uk/~pszdap/network/previous%20works

hops%20etc/understanding%20concept%20of%20knowledge%

20leakage/km.pdf

Search-enablers: Taxonomy, Metadata/Keyword, Folksonomy

http://www.kmworld.com/Articles/Editorial/What-Is-.../Taxonomy-101-The-Basics-and-Getting-Started-with-Taxonomies-98787.aspx

http://www.cs.nott.ac.uk/~pszdap/network/previous workshops etc/understanding concept of knowledge leakage/km.pdf

General Knowledge

Management (KM) Resources


General Knowledge Management (KM) Resources

Name Description Link

APQC: The

American

Productivity &

Quality Center

APQC is a member-based nonprofit professional KM Organization. It is an authority in benchmarking, best practices, process and performance improvement, and knowledge management. APQC partners with more than 500 member organizations worldwide in all industries.

www.apqc.org

Electronic Journal of

Knowledge

Management

The Electronic Journal of Knowledge Management (EJKM) publishes research on topics relevant to the study, implementation and management of knowledge management and intellectual capital and other related fields of study. The journal contributes to the development of both theory and practice in the field of knowledge management. The journal accepts academically robust papers, topical articles, communications, book reviews and case studies that contribute to the area of research in, and practice of knowledge management.

http://www.ejkm.com/main.html

Emerald Insight/

Journal of

Knowledge

Management

Journal of Knowledge Management is an online journal covering subject areas of HR & Organizational Behaviour, Information & Knowledge Management.

http://www.emeraldinsight.com/journal/jkm

Harvard Business

Review

Harvard Business Review (HBR) is a general management magazine published by Harvard Business Publishing, a wholly owned subsidiary of Harvard University. HBR's articles cover a wide range of topics that are relevant to different industries, management functions, and geographic locations. These focus on such areas as leadership, organizational change, negotiation, strategy, operations, marketing, finance, and managing people. Articles on knowledge management are published occasionally and are useful.

https://hbr.org/

http://www.apqc.org/

http://www.ejkm.com/main.html

http://www.emeraldinsight.com/journal/jkm

https://hbr.org/


General Knowledge Management (KM) Resources

Name Description Link

Journal of

Information &

Knowledge

Management

Journal of Information & Knowledge Management (JIKM) is a refereed journal published quarterly by World Scientific and dedicated to the exchange of the latest research and practical information in the field of information processing and knowledge management. The journal publishes original research and case studies by academic, business and government contributors on all aspects of information processing, information management, knowledge management, tools, techniques and technologies, knowledge creation and sharing, best practices, policies and guidelines.

http://www.worldscientific.com/worldscinet/jikm

KM World

KMWorld is a publisher, conference organizer, and information provider serving the knowledge management, content management, and document management markets. KMWorld also offers a number of special publications that will help identify sources for KM tools and hosts an ongoing series of web events on the latest trends and best practices in knowledge management.

http://www.kmworld.com/

KMT (Knowledge

Management Tools.

An Educational KM

Site)

A knowledge management site covering the theories, frameworks, models, tools, and supporting disciplines that are relevant to both the student and the practitioner. The goal of this site is to provide a comprehensive overview of knowledge management by examining its objectives, scope, strategy, best practices, knowledge management tools, and so on.

http://www.knowledge-management-tools.net/

Knoco Ltd

Knoco are knowledge management consultants helping organizations of any size to deliver tangible business value from their knowledge; by designing knowledge management strategies and frameworks, delivering knowledge management initiatives, and providing essential knowledge management toolkits. By working with world leaders in knowledge management over the past 20 years, Knoco helps clients in any sector improve performance and increase profitability through KM.

http://www.knoco.com/

LinkedIn Community

group for

Knowledge

Management

LinkedIn is the international social network, specializing in professional and business dealings. https://www.linkedin.com/

http://www.worldscientific.com/worldscinet/jikm

http://www.kmworld.com/

http://www.knowledge-management-tools.net/

http://www.knoco.com/

https://www.linkedin.com/


Selection of Publications supportive for Clinical Knowledge Management (CKM) framework implementation, sustaining and improvement

Reference Description link

O’Dell C, Hubert C. The New Edge in

Knowledge. John Wiley and Sons

publication. 2011.

In this book the authors reveal emerging best practices and proven strategies for creating and sustaining a successful KM program. Using examples from leading companies, the authors explore the latest issues in KM and share practical tools and real-world advice on putting KM to work for the organization.

www.newedgeinknowledge.com

Davenport TH, De Long DW, Beers

MC. Successful Knowledge

Management Projects. Sloan

Management Review. Winter 1998;

39, 2; ABI/INFORM Global, pg. 43

Paper summarizes investigations on 31 knowledge management projects in wide range from R&D to sale to production in 24 companies (9 in HP). Eight characteristics common for successful knowledge management projects were identified. Also some differences between success factors for knowledge management projects and other initiatives like data management or information were discussed

https://www.researchgate.net/profile/Thomas_Davenport2/publication/200045855_Building_Successful_Knowledge_Management_Projects/links/53db93a40cf216e4210bf847.pdf

Koenig MED. What is KM?

Knowledge Management

Explained. May 4, 2014

Paper summarizes history behind the Knowledge Management idea creation and evolution. Involves explanation of definition's development along time. Describes key elements and characteristics of KM today, as well as KM development stages.

http://www.kmworld.com/Articles/Editorial/What-Is-.../What-is-KM-Knowledge-Management-Explained-82405.aspx

Meeker-O’Connell A, Sam LM,

Bergamo N, Little JA.

TransCelerate’s Clinical Quality

Management System: From a Vision

to a Conceptual Framework. DIA

TIRS. May 30, 2016

This article chronicles the evolution of a TransCelerate paper describing a proposed clinical QMS conceptual framework and reviews feedback from varied global clinical trial stakeholders during socialization of the concept paper. The article also describes TransCelerate’s efforts to work with regulators to persuade Health Authorities to issue harmonized guidance on this important topic and reviews ongoing work to develop additional tools and resources that may support organizations in evaluating whether and how they might translate the conceptual framework principles into practice.

http://dij.sagepub.com/content/early/2016/05/30/2168479016651300?papetoc

Frost A. Defining Knowledge,

Information, Data [Internet]. KMT

(An Educational KM Site). 2010

[updated 2013; cited Feb 2, 2016].

Paper provides a short description of what constitutes knowledge and what falls under the category of information or data.

http://www.knowledge-management-tools.net/knowledge-information-data.html

http://www.newedgeinknowledge.com/

https://www.researchgate.net/profile/Thomas_Davenport2/publication/200045855_Building_Successful_Knowledge_Management_Projects/links/53db93a40cf216e4210bf847.pdf

http://www.kmworld.com/Articles/Editorial/What-Is-.../What-is-KM-Knowledge-Management-Explained-82405.aspx

http://dij.sagepub.com/content/early/2016/05/30/2168479016651300?papetoc

http://www.knowledge-management-tools.net/knowledge-information-data.html


Selection of Publications supportive for Clinical Knowledge Management (CKM) framework implementation, sustaining and improvement

Reference Description link

Why Information Technology

Inspired But Cannot Deliver

Knowledge Management.

California Management Review, Vol. 41, No. 4, Summer 1999.

Paper describes the difference between knowledge and information.http://www.comp.dit.ie/dgordon/Courses/ResearchMethods/Countdown/6Characteristics.pdf

Denning S. How Do You Change An

Organizational Culture? Forbes. Jul 23, 2011

World Bank case: Paper describes different strategies and efforts to change the World Bank from the small organization to what it is today. As it is presented, the most fruitful success strategy was to begin with leadership tools, cement the change in place with management tools, such as role definitions, measurement and control systems, and use the pure power tools as a last resort. An informative diagram of leadership, management and power tools is provided.

http://www.forbes.com/sites/stevedenning/2011/07/23/how-do-you-change-an-organizational-culture/

Katzenbach JR, Steffen I, Kronley C.

Cultural Change That Sticks.

Harvard Business Review. July–August 2012

Aetna case: Paper presents the story of how to change the culture building the new strategy on cultural strengths and engaging personnel. It advises to match strategy with the culture; focus on a few critical shifts in behavior; honor the strengths of existing culture; integrate formal and informal interventions; measure and monitor cultural evolution; treat cultural intervention as the first resort. Coherence among culture, strategic intent, and performance priorities can make the whole organization more attractive to both employees and customers.

https://hbr.org/2012/07/cultural-change-that-sticks

Murray A. How to Change Your

Organization’s Culture. Adapted in

part from “The Wall Street Journal

Guide to Management”. Published by Harper Business.

Tips: Start the change process with people who have disproportionate influence in the organization; look for ways to get people to experience the harsh realities that make change necessary; look for ways to redistribute resources toward “hot spots” – activities that require few resources but result in large change.

http://guides.wsj.com/management/innovation/how-to-change-your-organizations-culture/

Schultz J. Speed Camera Lottery

Wins VW Fun Theory Contest. The New York Times. 30 November 2010

A positive incentive case: how a positive incentive may change human behaviors in a desired direction. The incentive is based on the idea of camera measuring those who drive according to the required speed limits and randomly rewarding them, rather than identifying and punishing drivers for speeding.

http://wheels.blogs.nytimes.com/2010/11/30/speed-camera-lottery-wins-vw-fun-theory-contest/

http://www.comp.dit.ie/dgordon/Courses/ResearchMethods/Countdown/6Characteristics.pdf

http://www.forbes.com/sites/stevedenning/2011/07/23/how-do-you-change-an-organizational-culture/

https://hbr.org/2012/07/cultural-change-that-sticks

http://guides.wsj.com/management/innovation/how-to-change-your-organizations-culture/

http://wheels.blogs.nytimes.com/2010/11/30/speed-camera-lottery-wins-vw-fun-theory-contest/

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