Training Transcript for Kenya Mitchell Username: q762298 User number: 762298 E-mail: q762298@quintiles.com Activities Activity Code Estimated Credit Hours Start Date Completion Date Versional: Quintiles Infosario Overview and Reporting & Analytics Navigation QR002488 1 10/27/2014 10/27/2014 Course: Quintiles Infosario(R) Analytics: Overview and Navigation (9.0) Structure Change Date:9/9/2014 QR002488 1 10/27/2014 10/27/2014 Virtual Course: Work Life Balance Workshop QR002798 2 9/12/2014 9/12/2014 Virtual Class: Clinical Operations Work Life Balance Workshop QR002798 2 9/12/2014 9/12/2014 Course: Introduction to Good Clinical Practice, An Overview - Part 1 Structure Change Date:1/23/2012 G002460 1 6/13/2014 9/5/2014 Course: Global Privacy Awareness 2014 G003588 0.5 9/5/2014 9/5/2014 Course: PKR_ZWA22647_Kidney Disease (QR003781) QR003781 0.5 9/5/2014 9/5/2014 Course: Barnett Accreditation Fundamentals GCP Exam 2014 QR003733 1.41 6/30/2014 6/30/2014 Course: Peoplesoft Expenses 9.0 (Europe) Basic Navigation G000272 0.25 6/12/2014 6/12/2014 Course: ELVIS CF: EEL-Content EEL Document Management Specialist 2 (DMS2) Course: ELVIS CF: EEL-Content - EEL Document Management Specialist 1 (DMS1) QR003214 0.75 6/12/2014 6/12/2014 QR003213 0.75 6/11/2014 6/11/2014 Course: Peoplesoft Expenses 9.0 (Europe) Basic Navigation G000272 0.25 6/9/2014 6/9/2014 Course: ELVIS CF: EEL-Content and EEL Register Overview QR003198 0.75 5/5/2014 6/2/2014 Virtual Course: Quintiles Infosario Reporting & Analytics Interpreting Visualizations and Applying Critical Thinking Skills Virtual Class: Quintiles Infosario Reporting & Analytics Interpreting Visualizations and Applying Critical Thinking Skills Course: ELVIS Central Files - Functional Group Internal Workspace Training QR002525 2 5/6/2014 5/6/2014 QR002525 2 5/6/2014 5/6/2014 QR003227 0.75 5/2/2014 5/2/2014 Course: Anti-Corruption: Global Edition G003562 1 4/30/2014 4/30/2014 Course: Quintiles Code of Conduct Certification 2014 G002917 0.33 4/29/2014 4/29/2014 Course: Anti-kickback Compliance Program: Assessing Risks under the U.S. Anti-kickback Statute G002267 0.5 4/29/2014 4/29/2014 Course: PKR_YWA20816_Polycystic Kidney Disease (QR003500) QR003500 0.5 4/29/2014 4/29/2014 SkillSoft: (Archived)Communicating with Professionalism and Etiquette SSpd_25_a03_bs_enus 1 4/28/2014 4/28/2014 Course: (Archived)Training SOP Release - Clinical May 2014 (6.0) Structure Change Date:4/17/2014 QR002831 0.25 4/28/2014 4/28/2014 Course: ELVIS Central Files Email Management QR003212 0.75 1/29/2014 1/29/2014 Course: ELVIS CF: Physical Storage Overview QR003201 0.5 1/28/2014 1/28/2014 Course: ELVIS Central Files Project Controller Training QR003191 0.5 1/28/2014 1/28/2014 Course: IntraLinks Reviewer Training QR000314 2 12/12/2013 12/12/2013 Course: IntraLinks Publisher Training QR000313 2 12/11/2013 12/11/2013 Course: IntraLinks Manager Training QR000322 2.5 12/11/2013 12/11/2013 Course: CTMS: Non-Investigator- Contacts and Accounts Online Assessment (3.0) Structure Change Date:11/9/2011 Course: CTMS: Create and Update Contact Record-Non-Investigator (5.0) Structure Change Date:10/11/2010 Course: CTMS: Maintain Central IRB Submissions for a Protocol Country (3.0) Structure Change Date:4/2/2013 Course: CTMS: Create and Update Accounts Structure Change Date:10/7/2010 G002194 12/11/2013 12/11/2013 G002069 0.75 12/11/2013 12/11/2013 G002090 1 12/11/2013 12/11/2013 G002104 12/9/2013 12/11/2013 Course: CTMS: Maintain and Track Other Submission Records (2.0) G002088 1 12/10/2013 12/10/2013 Structure Change Date:3/11/2011 Course: CTMS: Maintain RA and CEC Submission Records (2.0) G002086 1 12/10/2013 12/10/2013 Structure Change Date:3/4/2011 Course: CTMS: Clinical Assistant Online Assessment (6.0) G002142 12/10/2013 12/10/2013 Page 1 / 5
Structure Change Date:4/13/2012 Course: CTMS: Submissions Overview (3.0) G002085 0.84 12/10/2013 12/10/2013 Structure Change Date:4/1/2013 Course: CTMS: Maintain Local Ethics/Central IRB Submissions for Project Site (2.0) Structure Change Date:3/9/2011 Course: CTMS: Country Submission Expert (CSE) Online Assessment (5.0) Structure Change Date:12/20/2011 G002091 1.5 12/9/2013 12/10/2013 G002158 12/9/2013 12/9/2013 Course: CTMS Simulation: Enter Protocol Country End of Trial (EoT) Dates & Status (Select >Project Close-out > Enter Protocol Country End of Trial (EoT) dates and statuses) Structure Change Date:9/20/2010 G002182 0.25 12/9/2013 12/9/2013 Course: CTMS: Maintain Import/Export Submission Records (3.0) G002087 0.33 12/9/2013 12/9/2013 Structure Change Date:4/1/2013 Course: CTMS: Apply Activity Template G002166 0.5 12/6/2013 12/6/2013 Structure Change Date:9/8/2010 Course: CTMS: Project Site Overview G002095 0.33 12/6/2013 12/6/2013 Structure Change Date:9/14/2010 Course: CTMS: Track & Maintain Document Translations G002076 0.25 12/6/2013 12/6/2013 Structure Change Date:11/11/2010 Course: CTMS: Create and Submit Contact Reports (2.0) G002074 0.2 12/6/2013 12/6/2013 Structure Change Date:1/25/2011 Course: CTMS: Associate Labs Structure Change Date:11/11/2010 G002057 1 12/6/2013 12/6/2013 Versional: CTMS: Project Site Management G002072 12/6/2013 12/6/2013 Course: CTMS: Project Site Management (2.0) G002072 1 12/6/2013 12/6/2013 Structure Change Date:10/19/2010 Course: CTMS: Associate Ethics Committees (2.0) G002056 0.2 12/6/2013 12/6/2013 Structure Change Date:8/10/2012 Course: CTMS: Document Tracking G002474 12/6/2013 12/6/2013 Structure Change Date:2/6/2012 Course: CTMS: Subject Enrollment & Subject Visits (3.0) G002073 0.8 12/6/2013 12/6/2013 Structure Change Date:11/16/2012 Versional: CTMS: Manage Periodic and Final Review(s) of Central Clinical File (CCF) & Central Investigator File (CIF) G002063 12/6/2013 12/6/2013 Course: CTMS: Manage Periodic and Final Review(s) of Central Clinical File (CCF) & Central Investigator File (CIF) Structure Change Date:7/28/2010 Versional: CTMS: Updating and Viewing Training for Internal and External Quintiles Employees Course: CTMS: Updating and Viewing Training for Internal and External Quintiles Employees (3.0) Structure Change Date:4/27/2012 G002063 0.25 12/6/2013 12/6/2013 G002062 12/5/2013 12/5/2013 G002062 0.25 12/5/2013 12/5/2013 Course: Regulated and Safety Data in CTMS QR002992 0.25 12/5/2013 12/5/2013 CS.OP.TR001 - V.2013 CS.OP.TR001 - V.2013 QR000242 12/4/2013 12/4/2013 QR000242 12/2/2013 12/2/2013 Course: ELVIS Central Files - Process Training QR003220 0.75 11/22/2013 11/22/2013 Course: ELVIS CF: EEL-Content and EEL Register Overview QR003198 0.75 11/22/2013 11/22/2013 Course: ELVIS Central Files Document Matrix and Naming Conventions QR003200 0.75 9/16/2013 9/16/2013 Course: ELVIS Central Files - Process Training QR003220 0.75 9/16/2013 9/16/2013 Course: ELVIS CF: EEL-Content EEL Review QC QR003199 0.75 9/13/2013 9/13/2013 Course: ELVIS CF: EEL-Content and EEL Register Overview QR003198 0.75 9/13/2013 9/13/2013 Course: Quintiles Policy & Guidelines on Corporate Communications G003112 0.5 9/4/2013 9/13/2013 Course: (Archived)Training SOP Release - Clinical (4.0) Structure Change Date:8/16/2013 QR002831 0.25 8/26/2013 8/26/2013 Course: (Archived)Training SOP Release - Clinical (Jun_2013) (3.0) Structure Change Date:5/22/2013 QR002831 0.25 5/22/2013 5/23/2013 Virtual Course: Work Life Balance Workshop QR002798 2 4/12/2013 4/12/2013 Virtual Class: Clinical Operations Work Life Balance Workshop QR002798 4/12/2013 4/12/2013 SkillSoft: (Archived)Leading Teams: Dealing with Conflict SSteam_03_a07_bs_enus 1 4/5/2013 4/5/2013 Course: (Archived)Training SOP Release - Clinical (Apr_2013) (2.0) QR002831 0.25 3/18/2013 3/18/2013 Page 2 / 5
Structure Change Date:3/15/2013 Course: MCO Programmatic Outsourcing Philosophy_V1_09Jul2012_Acknowledgement G003109 0.55 3/13/2013 3/13/2013 Document: MCO POST_Module Summary_V1_09Jul2012 G003106 0.25 3/12/2013 3/12/2013 Course: (Archived)Quintiles Code of Conduct Certification 2013 G002917-0 0.33 2/8/2013 2/8/2013 Course: Working in a Regulated Environment (WIRE) G002879 1 2/1/2013 2/1/2013 CS.OP.TR001 - V.2012 Course: CTMS: Add Team Members to All Protocol Records QR000242-5 1/23/2013 1/23/2013 G002055 0.75 11/6/2012 11/6/2012 Structure Change Date:8/31/2010 Course: MCO Clinical Supplies VP_V7_0_eff date 28Sep2012_TrainingAcknowledgement Course: CTMS: Query and Reporting (3.0) G003108 0.5 9/24/2012 9/24/2012 G001988 1 9/19/2012 9/19/2012 Structure Change Date:2/2/2012 Course: (Archived)Training SOP Release - Clinical (Oct_2012) Structure Change Date:9/11/2012 QR002831 0.25 9/18/2012 9/18/2012 Course: Laboratory Data in Clinical Trials QR000218 2 8/30/2012 8/30/2012 Course: Managing Study and Site Recruitment - The Basics QR002023 2 8/28/2012 8/30/2012 Structure Change Date:6/9/2010 Course: European Union Clinical Trials Directive - Basic Awareness QR000244 1.5 8/29/2012 8/29/2012 Course: Trial and Protocol Design V.2 G000195 1 8/29/2012 8/29/2012 Course: Phases in Clinical Trials V.2 G000196 1 8/29/2012 8/29/2012 Course: Who is Involved in Clinical Research V.2 G000194 1 8/28/2012 8/28/2012 Course: Introduction to Clinical Research V.2 G000197 1 4/9/2012 8/28/2012 Course: Employee Sexual Harassment Awareness Training - 2 part course G002501 1 8/16/2012 8/16/2012 Document: Training SOP Release August 01, 2012 - Clinical QR002779 0.25 7/18/2012 7/18/2012 Course: (Archived) MCO FCPA US and ex-us Sites Training Acknowledgement_eff date_15jun 2012 G003104 0.66 6/15/2012 6/15/2012 Document: MCO Compliance Checks WI US Sites_2_0_15Jun2012 G003105 0.25 6/15/2012 6/15/2012 Document: (Archived) MCO Compliance Checks and FCPA WI ex-us Sites_3_0_15Jun2012 G003107 0.25 6/15/2012 6/15/2012 Virtual Course: ICH GCP and E2A Refresher - Part 2 QR002047 2 6/13/2012 6/13/2012 Virtual Class: ICH GCP and E2A Refresher - Part 2 QR002047 6/13/2012 6/13/2012 Virtual Course: ICH GCP and E2A Refresher - Part 1 QR002045 2 6/12/2012 6/12/2012 Virtual Class: ICH GCP and E2A Refresher - Part 1 QR002045 6/12/2012 6/12/2012 Course: Barnett Accreditation: Fundamentals GCP EXAM for support staff QR002847 1.25 6/6/2012 6/6/2012 Course: Training SOP Release June 01, 2012 - Clinical QR002585 5/18/2012 5/18/2012 Versional: Fundamentals GCP Training (For Support Staff) QR002338 5/15/2012 5/15/2012 Course: Fundamentals GCP Training (For Support Staff) QR002338 1.5 5/15/2012 5/15/2012 Structure Change Date:6/1/2012 Course: CTMS: Navigation (3.0) Structure Change Date:2/2/2012 Course: CTMS: Overview (2.0) Structure Change Date:6/16/2011 Virtual Course: (Archived)ERES: Investigator Site Compliance with Part 11 Electronic Records and Electronic Signatures Virtual Class: ERES: Investigator Site Compliance with Part 11 Electronic Records and Electronic Signatures G001987 1 5/7/2012 5/7/2012 G002064 0.8 5/7/2012 5/7/2012 QR000001 5/4/2012 5/4/2012 QR000001 5/4/2012 5/4/2012 Document: Training COQM SOP Release April 01, 2012 QR002517 0.75 4/30/2012 4/30/2012 Document: Training SOP Release April 01, 2012 - Clinical QR002500 0.5 4/30/2012 4/30/2012 Course: Who is Involved in Clinical Research V.2 G000194 1 3/28/2012 3/28/2012 Course: Clinical Informatics - An Overview 2009 G001957 0.7 3/28/2012 3/28/2012 Course: (Archived) ELVIS CF: EEL Content v2.0 - Indexing and Review QC Course: (Archived) ELVIS CF: EEL Content v2.0 - Upload and Split Batch - Image QC Course: (Archived) ELVIS CF: EEL Content v2.0 - Rejection and Deletion Course: (Archived) ELVIS CF: EEL Content v2.0 Overview and Batch Registration Structure Change Date:12/7/2011 Course: (Archived) ELVIS Central Files QR002434 0.75 12/27/2011 12/27/2011 QR002433 1 12/20/2011 12/20/2011 QR002435 1 12/15/2011 12/20/2011 QR002429 12/15/2011 12/15/2011 QR002041 1 12/15/2011 12/15/2011 Structure Change Date:6/17/2010 Page 3 / 5
CS.OP.TR001 - V.2011 QR000242-4 12/13/2011 12/13/2011 Course: (Archived) Business Ethics at Quintiles G002374-0 1 11/23/2011 11/23/2011 Course: (Archived) ELVIS Customer Project Controller Training QR000385 0.5 11/7/2011 11/23/2011 Document: Training SOP Release 01 December 2011 - Clinical QR002419 11/18/2011 11/23/2011 Document: Training SOP Release 01 August 2011 - Clinical QR002329 9/16/2011 9/16/2011 Course: (Archived) Barnett - GCP for Clinical Trials staff interacting with investigational sites Structure Change Date:4/13/2012 Course: (Archived) Barnett Accreditation Good Clinical Practices for Administrative Staff (2011) QR002335-0 9/13/2011 9/14/2011 QR002458 1.5 9/14/2011 9/14/2011 Course: (Archived) Introduction to Anti-Bribery 2011 G002309 1 9/2/2011 9/2/2011 Course: (Archived) Global Privacy Awareness: Basic Training 2011 G002308 1 9/2/2011 9/2/2011 Course: (Archived) ELVIS Electronic Loader Content: Overview and Batch Registration Structure Change Date:9/20/2010 Course: (Archived) ELVIS Electronic Loader Content: Index/Review QC Structure Change Date:10/11/2010 Course: (Archived) ELVIS Central Files QR002183 1 8/9/2011 8/9/2011 QR002195 0.75 8/9/2011 8/9/2011 QR002041 1 8/9/2011 8/9/2011 Structure Change Date:6/17/2010 Course: (Archived) - EEL-Content: Upload and Split Batch Image QC Structure Change Date:10/14/2010 Course: (Archived) EEL-Content: Rejection and Deletion QR002196 1 8/8/2011 8/8/2011 QR002185 0.75 8/8/2011 8/8/2011 Structure Change Date:9/27/2010 ILT Course: Clinical Files: Setup, Maintenance and Archiving M000005 6/30/2011 6/30/2011 ILT Class: Clinical Files: Setup, Maintenance and Archiving M000005 6/30/2011 6/30/2011 Course: (Archived)Introduction to the Anti-kickback Statute and False Claims Act G002267-0 1 4/28/2011 4/28/2011 Versional: US Employee Handbook Acknowledgement M002265 4/6/2011 4/6/2011 Course: US Employee Handbook Acknowledgement M002265 0.25 4/6/2011 4/6/2011 Structure Change Date:3/14/2013 Document: Training SOP Release 01 April 2011 - Clinical QR002266 0.5 3/25/2011 3/25/2011 Course: ERES: Basic Part 11 Awareness QR000078 1 2/16/2011 2/16/2011 Course: Training SOP Release 01 March 2011 - Clinical QR002250 0.5 2/16/2011 2/16/2011 ILT Course: Corporate Orientation for New Employees G000103 7 2/15/2011 2/15/2011 ILT Class: Corporate Orientation for New Employees - QOPK G000103 2/15/2011 2/15/2011 Course: HIPAA Privacy Rule & HIPAA 2 QR000433 1.5 12/16/2010 12/16/2010 Course: (Archived) Global Privacy Awareness: Basic Training 2008 G000190 1.5 12/15/2010 12/15/2010 Course: CTMS: Query Basics Structure Change Date:6/9/2011 Course: (Archived) CTMS: Advanced Query and Reporting G001988 1 12/15/2010 12/15/2010 G002109 0.75 12/2/2010 12/2/2010 Structure Change Date:9/3/2010 Document: (Archived) Training SOP Release 01 December 2010- Clinical QR002215 0.5 12/1/2010 12/1/2010 Course: (Archived) Business Ethics at Quintiles G000013-A 1 11/8/2010 11/8/2010 Course: Email & Calendar Navigation & Etiquette Course (Outlook) G000075 11/8/2010 11/8/2010 Course: Instant Messaging: Communicator G000006 11/8/2010 11/8/2010 Course: CTMS: Overview Structure Change Date:9/8/2010 G002064 0.8 11/8/2010 11/8/2010 Virtual Course: ICH GCP and E2A Refresher - Part 2 QR002047 2 11/5/2010 11/5/2010 Virtual Class: ICH GCP and E2A Refresher - Part 2 QR002047 11/5/2010 11/5/2010 Course: (Archived) Training SOP Release 01 October 2010 - Clinical QR002180 0.5 11/4/2010 11/4/2010 Course: InForm 4.5 to 4.6 Bridge Training QR000362 0.5 10/21/2010 10/21/2010 Course: (Archived) CTMS: Advanced Navigation (2.0) G002078 1.3 10/1/2010 10/1/2010 Structure Change Date:9/10/2010 Course: CTMS: Navigation Structure Change Date:9/2/2010 ILT Course: Regulatory Documents: Collection, Review, Approval and Maintenance ILT Class: Regulatory Documents: Collection, Review, Approval and Maintenance G001987 1 9/30/2010 9/30/2010 M000020 7/27/2010 7/28/2010 M000020 7/27/2010 7/28/2010 Versional: ELVIS Curriculum Vitae (CV) e-learning G002012 1 7/21/2010 7/22/2010 Page 4 / 5
Course: ELVIS Curriculum Vitae (CV) e-learning G002012 1 7/21/2010 7/22/2010 Structure Change Date:4/16/2010 Course: (Archived) Training SOP Release 01 August 2010 - Clinical QR002052 0.2 7/16/2010 7/16/2010 Course: Informatics: E-Briefcase Training QR000184 2 7/9/2010 7/9/2010 Course: ELVIS: Clinical Orgamizational Area Overview: Clinical Operations Staff QR000329 0.5 7/8/2010 7/9/2010 Versional: Getting Started in ELVIS - Basic (English Version) G000213 1 7/8/2010 7/8/2010 Course: Getting Started in ELVIS - Basic (English version) G000213 1 7/8/2010 7/8/2010 Structure Change Date:11/7/2012 Objective: Getting Started in ELVIS Basic G000213 1 7/8/2010 7/8/2010 Course: Informatics Site Start Up Application (v3.0) elearning Training QR000465 3.25 7/8/2010 7/8/2010 Course: InFORMant v1.9 Self Study Training QR000321 3 7/8/2010 7/8/2010 Course: Informatics General Functionality Training Version 4 QR000418 1 7/7/2010 7/8/2010 Course: (Archived) 00001 InForm Training QC000074 1.5 7/7/2010 7/7/2010 Course: Global Clinical Development Services (CDS) Strategy Map Video Course: (Archived) Anti-kickback Statute and False Claims Act: Projects Involving Marketed Products Course: InnTrax Basic User e-learning For Read-Write CRAs (Europe/AAA) and CTAs QR000352 7/7/2010 7/7/2010 G000159 7/7/2010 7/7/2010 QR000273 2 7/6/2010 7/7/2010 Course: Employee PeopleSoft v9 Time & Labor Training G000217 1 7/6/2010 7/6/2010 Course: ELVIS esop Basic User Training QR000396 0.5 7/6/2010 7/6/2010 Course: Learning Curve: Learner Role V8.2 G002009 0.5 7/6/2010 7/6/2010 Self-Reported Training Activity Code Estimated Credit Hours Start Date Completion Date **SELF-REPORTED TRAINING***: Recent Audit Findings in Canada : Impact on Quintiles Processes **SELF-REPORTED TRAINING***: October 2013 Training SOP Release **SELF-REPORTED TRAINING***: August 2012 Training SOP Release **SELF-REPORTED TRAINING***: A Critical Quality Issue SC Alleged Misconduct **SELF-REPORTED TRAINING***: ELVIS Central FIles - QSite Launch **SELF-REPORTED TRAINING***: ELVIS Central Files: Folder Matrix and Naming Conventions **SELF-REPORTED TRAINING***: FDA Regulations-Summary of Changes Effective 28 Mar 2011 11/18/2014 11/18/2014 9/26/2013 9/26/2013 7/25/2012 7/25/2012 8/26/2011 8/26/2011 8/18/2011 8/18/2011 8/9/2011 8/9/2011 3/4/2011 3/4/2011 **SELF-REPORTED TRAINING***: ERES Basic Part 11 Awareness QR000078 2/16/2011 2/16/2011 **SELF-REPORTED TRAINING***: Coporate Orientation for New Employees **SELF-REPORTED TRAINING***: Document Tracking Spreadsheet Revision 3 **SELF-REPORTED TRAINING***: Inspection Readiness Initiative: FDA Compliance Program/Regulatory Inspection Procedure G000103 2/15/2011 2/15/2011 CS_WI_RM050 1/31/2011 1/31/2011 8/6/2010 8/6/2010 Page 5 / 5