Systems Approach to Training

Systems Approach to Training as part of risk management and solution development

1. 7/7/2015 ARETE-ZOE, LLC 1 EVALUATE ANALYZE DESIGN DEVELOP IMPLEMENT SYSTEMS APPROACH TO TRAINING What to train Where to train When to train How to train Who to train How well we trained

2. Input Process Evaluation data Changed situation Different needs Changed requirements R eorganization Output Roles & Responsibilities Analysis of functional needs is necessary to produce Design of the system as appropriate/relevant for its current and estimated future scope of activities. The products of analysis will be the foundation of what constitutes a successful design. Design translates analysis data into a structure or blueprint of both organization and process. PERFORMANCE data is collected to produce a comprehensive list of tasks and performance requirements, Roles & Responsibilities and draft Training Plan 7/7/2015 ARETE-ZOE, LLC 2 Job analysis Task analysis Performance requirements Responsibilities Determine setting Materials Training Plan ANALYSIS MISSION ANALYSIS | COLLECTIVE TASK ANALYSIS | JOB ANALYSIS | INDIVIDUAL TASK ANALYSIS

3. T he outputs of the ANALYSIS Phase become the inputs to the DESIGN Phase. The objective of training is to simulate functioning of the system as closely as possible to the actual environment. Input Process Output Roles & Responsibilities Training Plan Target population Learning objectives Learning analysis hierarchies Sequence training Select training site Learning strategy Learning activities Design test Target population The outputs of the Design phase include: Charts with organizational structure, task list inventory by staff position and function, flowchart describing data flow including all interfaces, a list of SOPs, Working Instructions, and Training Materials which will have to be created including definition of scope and for whom they will be relevant. 7/7/2015 ARETE-ZOE, LLC 3 DESIGN TARGET POPULATION | LEARNING OBJECTIVES | LEARNING STRATEGIES & METHODS | TESTS Test items Methods, Media Flowcharts, charts List of SOPs, WIs List of TMs

4. Input Process Target Population Description TEST items Methods & Media Charts, flowcharts List of SOPs and WIs, Training materials list Output System Master File Development involves turning the design outputs into the products, programs, and materials required to implement clinical research activities at organizational and individual level. Products include SOPs and Working Instructions according to scope and definition described in the Design phase. Evaluation of all developed materials is a critical part of the development process because it validates their practicality. FLOWCHARTS, SOPs, manuals, risk management plans, training structure and materials, and construction and validation of tests to determine effectiveness of the system prior to its implementation. 7/7/2015 ARETE-ZOE, LLC 4 DEVELOPMENT Review design outputs Revise current material Establish a team of subject matter experts Plan instructor training Plan key personnel training In-Process Reviews (IPRs) Review developed products Staff preliminary products Validate products and tests Make necessary revisions Obtain approval/authorization Reproduce products Acquire resources

5. Input Process System Master File Output Trained staff, faculty and cadre Implementation is preparing for, training and conducting all activities according to SOPs and WIs, using materials , documents, platforms, templates, and methods designed and developed in previous phases. Key activities: Train relevant people on activities relevant to them as defined in previous phases using training materials designed phase I and developed in phase II; conduct activities as described in Master File; Collect and collate data on performance of the system as whole necessary for its continuing evaluation, in order to detect, revise, and correct any occurring inefficiencies. Document key decisions and maintain audit trail to support any decisions made and actions taken during the implementation process. T ransition of a blueprint into real-world environment and conducting instruction, tests, and evaluations according to SMF to enable personnel to achieve their individual and collective objectives. 7/7/2015 ARETE-ZOE, LLC 5 IMPLEMENTATION Train staff, faculty and cadre for their duties Maintain records Conduct training Use validated materials Develop schedules Collect and collate data Maintain audit trail Training records Documentation of training modifications and rationale Audit trail

6. Input Process Test Data Data collected on performance of the system Output Evaluation summary Evaluation is essential to determine if the system as designed, developed, and implemented meets its business needs. Evaluation provides the data to determine if individu a ls can perform the tasks assigned to them to the expected standard, and if individual sites and the organization as whole can accomplish their objectives to the required standards and at within established time lines. Evaluation also provides data if the system as whole is appropriate and cost effective. Internal and external audit validates the system as whole with regards to regulatory compliance in target markets. Needs analysis shall verify a training problem and identify non-training solutions to a performance problem, such as doctrine, leadership, organization, and material required capabilities. EVALUATION is based on criterion-referenced checks which ensure continuous improvement of a newly developed system. 7/7/2015 ARETE-ZOE, LLC 6 EVALUATION Plan evaluation Internal evaluation External evaluation Analyze data Manage data Revisions as necessary Needs analysis