PROGRAM OVERVIEW The Program Components Include • DataLabs and Designer orientation to improve familiarity to the tools TRAINER CERTIFICATION PROGRAM DataLabs® EDC ranks highest in overall satisfaction in ISR’s 2011 The State of the EDC Market Report, an independent study conducted by Industry Standard Research (ISR). Implemented by 15 of the top 35 global pharmaceutical companies, the time is right to empower the clinical study team. Training is paramount to successful implementation of clinical trial systems. The DataLabs EDC training program gives the opportunity to both sites and sponsors to not only recognize the advantages of DataLabs but to increase their knowledge, self-reliance and confidence in the product. The program provides knowledge, skills, assessment and practice simulation opportunities required to manage clinical study build and the study lifecycle. The DataLabs EDC Train the Trainer program is a role-based modular program allowing both larger and smaller organizations to pull in the relevant training modules and delivery needs to suit their organizations’ needs, budget and timeframes. We understand that organizations are not the same and have different needs and budget. Our program is designed to allow our clients to pick and mix. The Train the Trainer Program This program focuses on DataLabs EDC and DataLabs Designer to facilitate knowledge transfer and provide the necessary skills and understanding for your designated trainers to train other system users. Certifying your trainers will enable self-sufficiency, cut costs, convenience for your organization, and help you scale. Being modular-based, the course can be customized to suit the audience needs and expectations. Certification Levels • Training modules covering the breadth of clinical trial roles spanning from the daily activities of a site user to the monitoring and data review/analysis of the project team • Instructor principles and delivery reference aids • Training process guide The DataLabs EDC Train the Trainer program covers ‘Software knowledge’, the core Perceptive Institute modules and ‘Training Skills’ covering system practice and dry-runs leading to final Certification. Methods of training will cover topic information, scenarios, hands-on practise, exercises, group sessions for instructor-led training and demonstrations. These will be delivered in a variety of delivery mediums including classroom virtual and instructor-led training; and eLearning. Aftercare • DataLabs Certified Trainer Once certified we will enable continuous development through: • Designer Certified Trainer • Trainer support help • Train the trainer practical and online assessment which will lead to a recognized certification • System version updates • Re-certification to maintain knowledge ILT: Instructor-led training E: eLearning FOUNDATION ROLE-BASED ADMINISTRATOR DATA MANAGER DESIGNER ILT / E ILT / E ILT / E ILT / E ILT DataLabs for Clinical Monitors Orientation to DataLabs EDC and Designer DataLabs for Principal Investigators DataLabs for Medical Monitors DataLabs for View Only Roles DataLabs Version Upgrade Designer Workshop DataLabs for Paper Data Entry DataLabs for Data Management Leads & Certification DataLabs for Data Managers and Certification ILT DataLabs Trainer Certification Program • Pre-requisite knowledge to the full curriculum Role-based Learning • Demonstrations and simulations • Self-assessment and certification Certification Programs IB Reporting for Standard Reports • Focused on specific tasks and needs: reporting and study design • Self-assessment and certification DataLabs for Administrators & Certification IB Reporting for Custom Reports Designer Version Upgrade (eLearning) DataLabs Site Trainer Certification program Trainer Certification • Equip and empower your organization to scale delivery and cut costs • Modular blended program suited to audience knowledge Loading and Managing External Data • Enable self sufficiency DataLabs Designer Certified Designer Trainer Certification Program DS Navigator The Perceptive Institute training Certification logos may be used only by individuals who have attended and passed the relevant course and assessment requirements for a specific certification (such as Certified Designer and Certified DataLabs trainer) and have been notified in writing by Perceptive Institute that said participant has achieved Certification status. All certified individuals are held on a Perceptive Institute training database. Individuals may hold multiple certifications. ©2014 PAREXEL International Corporation. All rights reserved. Perceptive, DataLabs and Perceptive MyTrials are trademarks or registered trademarks of PAREXEL International Corporation or its subsidiaries. All other trademarks are the property of their respective owners and are hereby acknowledged. A PAREXEL® Training and Certification Program. • Applicable to all users and roles • Role-based modules mapped to study administration specification roles IB Reporting for Dashboard DataLabs for Paper Data Entry CERTIFIED TRAINER Foundation Learning • Access to the new versions of the training content • Access to up to date Trainer guides and Student guides
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