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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.
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.
Examples of Current Modalities for Training• Presentation• ILT• Paper-based• Peers• OJT• eLearning• Websites• Prayer
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)
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.
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
Delivery Mechanisms• Evolved over time Storytelling Hieroglyphics Records (Paper) Books Teachers Instructors eLearning Self Gaming
Getting ISD Back• Requirements• Objectives• Rapid ID – Classify, design and execute• Rapid Development Tools Articulate Raptivity Engage Captivate• Add and Stick to Process
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
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
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
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)
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
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
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
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
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.
Measuring Performance• Direct Pre-tests establish baseline knowledge Post-tests establish comprehension Recertification establishes learning• Indirect Less training required Decreased rates of failure
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)
Acting on the Results• Training/Assessment Revision• New Training• Following up with Reinforcement 40/20/40 Rule