1. Instructional Design
A forgotten art?
Considerations, guidelines and suggested
methodologies for bringing instructional
design back to the fore-front of training
and performance improvement.
Jim Wetzel – Manager, Performance Technology, Kendle Inc.
2. Objectives
• Describe the attributes of learning and
instructional design.
• Recognize why ISD is not always given the
importance it should.
• Provide some examples of good and bad design.
• List steps that can be taken to improve ISD.
• Outline ways to measure if this works.
4. Examples of Current Modalities for Training
• Presentation
• ILT
• Paper-based
• Peers
• OJT
• eLearning
• Websites
• Prayer
5. What is Training/Instruction
• Training is a way to improve performance
• Components of Training
Measurement
Instruction
Structure
Accessibility
Feedback
• Its about the objectives - (Key Objective)
6. What is Instructional Design
• Instructional Design is a systematic way of
presenting content in such a way that a
defined audience has the best probability
or learning, applying and retaining the
material presented.
7. What is Learning?
• Measurable and demonstrable
performance over time
• Rote memorization of a fact
• Acquisition of a skill(s)
• Changes in attitude
• Measurement is always indirect and
inferred
8. Delivery Mechanisms
• Evolved over time
Storytelling
Hieroglyphics
Records (Paper)
Books
Teachers
Instructors
eLearning
Self
Gaming
10. Forgotten
• Who forgot ISD?
Was it ever really known and understood?
• Why is ISD neglected?
Ignorance
Time
Perception – (Lots of poor courseware)
Complex Content
11. Forgetting ISD Starts Early
• SMEs rarely make the best teachers
• If you are a SME, let the IDs lead
Ensure facts and processes are correct
Focus on objectives
25. Getting ISD Back
• Requirements
• Objectives
• Rapid ID – Classify, design and execute
• Rapid Development Tools
Articulate
Raptivity
Engage
Captivate
• Add and Stick to Process
26. Strategies for Simple Content
• Classify into domains of learning
Facts
Concepts
Rules/Procedures
Attitudes
• Once classified, add strategy
Big and Small
• Content reinforcement techniques
• Bananas
• Test-out options/exemptions
29. Objectives
By the end of this training module, you will
be able to:
• Know the structure of a CTD formatted
submission
• Know the roles and responsibilities of key
Submission Team members
• Know how to plan for a successful CTD
submission
30. What is a CTD?
• CTD = Common Technical Document Organized into five
modules:
– Module 1: Regional Information (EU, US, JP)
– Module 2: CTD Summaries
• Overall CTD Table of Contents and Introduction
• Quality Overall Summary
• Nonclinical Overview and Summary
• Clinical Overview and Summary
– Module 3: Quality (Chemistry, Manufacturing, Controls)
– Module 4: Nonclinical Study Reports (early development safety)
– Module 5: Clinical Study Reports (late development safety &
efficacy)
What is wrong with this screen?
Hint: Title
31. Where do you start?
• Poor writing skills - the # 1 problem
Content Outline – Get one. (Organization)
Determine if current content supports the
outline. (Clarity)
Now focus on classification and instructional
strategies. (Design)
33. Chapter 1 - Overview: Format of CTD Structure, Responsibilities & Planning
Chapter Objectives
By the end of this training module, you
will be able to:
– Describe the structure of a CTD
formatted submission
– Identify the roles and responsibilities of
key Submission Team members
– State how to plan for a successful CTD
submission
34. Chapter 1 - Overview: Format of CTD Structure, Responsibilities & Planning
CTD and eCTD Defined
What is a CTD an how is it different
from an eCTD?
The Common Technical Document (CTD) is a
document template that provides a common
format for the preparation of the documentation
to support a Marketing Authorization Application
(i.e. a new drug application) that will be
submitted to the regulatory authorities.
The electronic Common Technical Document
(eCTD) is a computer-based interface for
companies to transfer submission information to
regulatory authorities.
While the CTD defines the content the document
is to contain, the eCTD defines the electronic
structure.
Note: The CTD is defined by the International Conference
on Harmonization (ICH) M4 Expert Working Group
Module 1
Regional
Administrative
Information
Module 3
Quality
Module 4
Nonclinical
Study Reports
Module 5
Clinical Study
Reports
2.1 TOC
2.2 Introduction
2.3 Quality
Overall
Summary
2.4 Nonclinical
Overview
2.5 Clinical
Overview
2.6 Nonclinical
Summaries
2.7 Clinical
Summaries
CTD Pyramid
Module 2
Summaries
Quality / CMC Preclinical Clinical
35. Strategies for Complex Content
• Recognize the sophistication/education level of
the audience
Why? Provides baseline for writing and design
• Define the instructional goal and performance
objectives
• Develop instruction strategies for content, e.g.,
tumor assessment/dosing exercises
• Leverage SMEs
• Simulations, Case Studies
37. Background on Process
• Most Instructional Design groups are small
• Process is either non-existent or inherited
• SDLC is a foreign concept
• Many parallels to software development
• Vendors somewhat better than internal depts.
• Not many good standards out there
ISO
SCORM
39. Adding Process
• Find one, build one, or buy one
• Ban PowerPoint
• Ensure it spans the gamut from Kick-off to
Closeout and all points in between.
Presales
Design
Development
Testing
QA
• Work toward a methodology.
42. Measuring Performance
• Direct
Pre-tests establish baseline knowledge
Post-tests establish comprehension
Recertification establishes learning
• Indirect
Less training required
Decreased rates of failure
43. Additional Measurement Techniques
• Kirkpatrick's 4 levels of evaluating training
effectiveness
Level I - “Did they like it?” (a.k.a feedback)
Level II - “Did they learn it?” (assessment results)
Level III - “Can they do it?” (application)
Level IV - “Did it work?” (better mission execution)
44. Acting on the Results
• Training/Assessment Revision
• New Training
• Following up with Reinforcement
40/20/40 Rule