1. Instructional DesignA forgotten art?Considerations, guidelines and suggestedmethodologies for bringing instructionaldesign back to the fore-front of trainingand performance improvement.Jim Wetzel – Manager, Performance Technology, Kendle Inc.
2. Objectives• Describe the attributes of learning andinstructional design.• Recognize why ISD is not always given theimportance 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.
3. Instructional Design
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 ofpresenting content in such a way that adefined audience has the best probabilityor learning, applying and retaining thematerial presented.
7. What is Learning?• Measurable and demonstrableperformance over time• Rote memorization of a fact• Acquisition of a skill(s)• Changes in attitude• Measurement is always indirect andinferred
8. Delivery Mechanisms• Evolved over time­ Storytelling­ Hieroglyphics­ Records (Paper)­ Books­ Teachers­ Instructors­ eLearning­ Self­ Gaming
9. Forgotten Art
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
12. Glycolysis - The Hard Way
13. Glycolysis The Easy Way
14. Art• Interactivity, Schminteractivity­ History Channel
15. Where’s the Banana?
16. Sweet Maria’s
17. Sweet Marias?
18. Sweet Marias?
19. Sweet Marias?
20. Sweet Marias
21. Sweet Maria’s• Why does this work?• Motivation• Schema Theory of Learning
22. Google vs. Yahoo
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
27. Simple Content Example
28. Before ISD
29. ObjectivesBy the end of this training module, you willbe able to:• Know the structure of a CTD formattedsubmission• Know the roles and responsibilities of keySubmission Team members• Know how to plan for a successful CTDsubmission
30. What is a CTD?• CTD = Common Technical Document Organized into fivemodules:– 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 theoutline. (Clarity)­ Now focus on classification and instructionalstrategies. (Design)
32. After ISD
33. Chapter 1 - Overview: Format of CTD Structure, Responsibilities & PlanningChapter ObjectivesBy the end of this training module, youwill be able to:– Describe the structure of a CTDformatted submission– Identify the roles and responsibilities ofkey Submission Team members– State how to plan for a successful CTDsubmission
34. Chapter 1 - Overview: Format of CTD Structure, Responsibilities & PlanningCTD and eCTD DefinedWhat is a CTD an how is it differentfrom an eCTD?The Common Technical Document (CTD) is adocument template that provides a commonformat for the preparation of the documentationto support a Marketing Authorization Application(i.e. a new drug application) that will besubmitted to the regulatory authorities.The electronic Common Technical Document(eCTD) is a computer-based interface forcompanies to transfer submission information toregulatory authorities.While the CTD defines the content the documentis to contain, the eCTD defines the electronicstructure.Note: The CTD is defined by the International Conferenceon Harmonization (ICH) M4 Expert Working GroupModule 1RegionalAdministrativeInformationModule 3QualityModule 4NonclinicalStudy ReportsModule 5Clinical StudyReports2.1 TOC2.2 Introduction2.3 QualityOverallSummary2.4 NonclinicalOverview2.5 ClinicalOverview2.6 NonclinicalSummaries2.7 ClinicalSummariesCTD PyramidModule 2SummariesQuality / CMC Preclinical Clinical
35. Strategies for Complex Content• Recognize the sophistication/education level ofthe audience­ Why? Provides baseline for writing and design• Define the instructional goal and performanceobjectives• 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
38. Injecting Process
39. Adding Process• Find one, build one, or buy one• Ban PowerPoint• Ensure it spans the gamut from Kick-off toCloseout 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• Kirkpatricks 4 levels of evaluating trainingeffectiveness­ 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