Training Transcript for Kenya Mitchell

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1 Training Transcript for Kenya Mitchell Username: q User number: Activities Activity Code Estimated Credit Hours Start Date Completion Date Versional: Quintiles Infosario Overview and Reporting & Analytics Navigation QR /27/ /27/2014 Course: Quintiles Infosario(R) Analytics: Overview and Navigation (9.0) Structure Change Date:9/9/2014 QR /27/ /27/2014 Virtual Course: Work Life Balance Workshop QR /12/2014 9/12/2014 Virtual Class: Clinical Operations Work Life Balance Workshop QR /12/2014 9/12/2014 Course: Introduction to Good Clinical Practice, An Overview - Part 1 Structure Change Date:1/23/2012 G /13/2014 9/5/2014 Course: Global Privacy Awareness 2014 G /5/2014 9/5/2014 Course: PKR_ZWA22647_Kidney Disease (QR003781) QR /5/2014 9/5/2014 Course: Barnett Accreditation Fundamentals GCP Exam 2014 QR /30/2014 6/30/2014 Course: Peoplesoft Expenses 9.0 (Europe) Basic Navigation G /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) QR /12/2014 6/12/2014 QR /11/2014 6/11/2014 Course: Peoplesoft Expenses 9.0 (Europe) Basic Navigation G /9/2014 6/9/2014 Course: ELVIS CF: EEL-Content and EEL Register Overview QR /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 QR /6/2014 5/6/2014 QR /6/2014 5/6/2014 QR /2/2014 5/2/2014 Course: Anti-Corruption: Global Edition G /30/2014 4/30/2014 Course: Quintiles Code of Conduct Certification 2014 G /29/2014 4/29/2014 Course: Anti-kickback Compliance Program: Assessing Risks under the U.S. Anti-kickback Statute G /29/2014 4/29/2014 Course: PKR_YWA20816_Polycystic Kidney Disease (QR003500) QR /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 QR /28/2014 4/28/2014 Course: ELVIS Central Files Management QR /29/2014 1/29/2014 Course: ELVIS CF: Physical Storage Overview QR /28/2014 1/28/2014 Course: ELVIS Central Files Project Controller Training QR /28/2014 1/28/2014 Course: IntraLinks Reviewer Training QR /12/ /12/2013 Course: IntraLinks Publisher Training QR /11/ /11/2013 Course: IntraLinks Manager Training QR /11/ /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 G /11/ /11/2013 G /11/ /11/2013 G /11/ /11/2013 G /9/ /11/2013 Course: CTMS: Maintain and Track Other Submission Records (2.0) G /10/ /10/2013 Structure Change Date:3/11/2011 Course: CTMS: Maintain RA and CEC Submission Records (2.0) G /10/ /10/2013 Structure Change Date:3/4/2011 Course: CTMS: Clinical Assistant Online Assessment (6.0) G /10/ /10/2013 Page 1 / 5

2 Structure Change Date:4/13/2012 Course: CTMS: Submissions Overview (3.0) G /10/ /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 G /9/ /10/2013 G /9/ /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 G /9/ /9/2013 Course: CTMS: Maintain Import/Export Submission Records (3.0) G /9/ /9/2013 Structure Change Date:4/1/2013 Course: CTMS: Apply Activity Template G /6/ /6/2013 Structure Change Date:9/8/2010 Course: CTMS: Project Site Overview G /6/ /6/2013 Structure Change Date:9/14/2010 Course: CTMS: Track & Maintain Document Translations G /6/ /6/2013 Structure Change Date:11/11/2010 Course: CTMS: Create and Submit Contact Reports (2.0) G /6/ /6/2013 Structure Change Date:1/25/2011 Course: CTMS: Associate Labs Structure Change Date:11/11/2010 G /6/ /6/2013 Versional: CTMS: Project Site Management G /6/ /6/2013 Course: CTMS: Project Site Management (2.0) G /6/ /6/2013 Structure Change Date:10/19/2010 Course: CTMS: Associate Ethics Committees (2.0) G /6/ /6/2013 Structure Change Date:8/10/2012 Course: CTMS: Document Tracking G /6/ /6/2013 Structure Change Date:2/6/2012 Course: CTMS: Subject Enrollment & Subject Visits (3.0) G /6/ /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) G /6/ /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 G /6/ /6/2013 G /5/ /5/2013 G /5/ /5/2013 Course: Regulated and Safety Data in CTMS QR /5/ /5/2013 CS.OP.TR001 - V.2013 CS.OP.TR001 - V.2013 QR /4/ /4/2013 QR /2/ /2/2013 Course: ELVIS Central Files - Process Training QR /22/ /22/2013 Course: ELVIS CF: EEL-Content and EEL Register Overview QR /22/ /22/2013 Course: ELVIS Central Files Document Matrix and Naming Conventions QR /16/2013 9/16/2013 Course: ELVIS Central Files - Process Training QR /16/2013 9/16/2013 Course: ELVIS CF: EEL-Content EEL Review QC QR /13/2013 9/13/2013 Course: ELVIS CF: EEL-Content and EEL Register Overview QR /13/2013 9/13/2013 Course: Quintiles Policy & Guidelines on Corporate Communications G /4/2013 9/13/2013 Course: (Archived)Training SOP Release - Clinical (4.0) Structure Change Date:8/16/2013 QR /26/2013 8/26/2013 Course: (Archived)Training SOP Release - Clinical (Jun_2013) (3.0) Structure Change Date:5/22/2013 QR /22/2013 5/23/2013 Virtual Course: Work Life Balance Workshop QR /12/2013 4/12/2013 Virtual Class: Clinical Operations Work Life Balance Workshop QR /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) QR /18/2013 3/18/2013 Page 2 / 5

3 Structure Change Date:3/15/2013 Course: MCO Programmatic Outsourcing Philosophy_V1_09Jul2012_Acknowledgement G /13/2013 3/13/2013 Document: MCO POST_Module Summary_V1_09Jul2012 G /12/2013 3/12/2013 Course: (Archived)Quintiles Code of Conduct Certification 2013 G /8/2013 2/8/2013 Course: Working in a Regulated Environment (WIRE) G /1/2013 2/1/2013 CS.OP.TR001 - V.2012 Course: CTMS: Add Team Members to All Protocol Records QR /23/2013 1/23/2013 G /6/ /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) G /24/2012 9/24/2012 G /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 QR /18/2012 9/18/2012 Course: Laboratory Data in Clinical Trials QR /30/2012 8/30/2012 Course: Managing Study and Site Recruitment - The Basics QR /28/2012 8/30/2012 Structure Change Date:6/9/2010 Course: European Union Clinical Trials Directive - Basic Awareness QR /29/2012 8/29/2012 Course: Trial and Protocol Design V.2 G /29/2012 8/29/2012 Course: Phases in Clinical Trials V.2 G /29/2012 8/29/2012 Course: Who is Involved in Clinical Research V.2 G /28/2012 8/28/2012 Course: Introduction to Clinical Research V.2 G /9/2012 8/28/2012 Course: Employee Sexual Harassment Awareness Training - 2 part course G /16/2012 8/16/2012 Document: Training SOP Release August 01, Clinical QR /18/2012 7/18/2012 Course: (Archived) MCO FCPA US and ex-us Sites Training Acknowledgement_eff date_15jun 2012 G /15/2012 6/15/2012 Document: MCO Compliance Checks WI US Sites_2_0_15Jun2012 G /15/2012 6/15/2012 Document: (Archived) MCO Compliance Checks and FCPA WI ex-us Sites_3_0_15Jun2012 G /15/2012 6/15/2012 Virtual Course: ICH GCP and E2A Refresher - Part 2 QR /13/2012 6/13/2012 Virtual Class: ICH GCP and E2A Refresher - Part 2 QR /13/2012 6/13/2012 Virtual Course: ICH GCP and E2A Refresher - Part 1 QR /12/2012 6/12/2012 Virtual Class: ICH GCP and E2A Refresher - Part 1 QR /12/2012 6/12/2012 Course: Barnett Accreditation: Fundamentals GCP EXAM for support staff QR /6/2012 6/6/2012 Course: Training SOP Release June 01, Clinical QR /18/2012 5/18/2012 Versional: Fundamentals GCP Training (For Support Staff) QR /15/2012 5/15/2012 Course: Fundamentals GCP Training (For Support Staff) QR /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 G /7/2012 5/7/2012 G /7/2012 5/7/2012 QR /4/2012 5/4/2012 QR /4/2012 5/4/2012 Document: Training COQM SOP Release April 01, 2012 QR /30/2012 4/30/2012 Document: Training SOP Release April 01, Clinical QR /30/2012 4/30/2012 Course: Who is Involved in Clinical Research V.2 G /28/2012 3/28/2012 Course: Clinical Informatics - An Overview 2009 G /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 QR /27/ /27/2011 QR /20/ /20/2011 QR /15/ /20/2011 QR /15/ /15/2011 QR /15/ /15/2011 Structure Change Date:6/17/2010 Page 3 / 5

4 CS.OP.TR001 - V.2011 QR /13/ /13/2011 Course: (Archived) Business Ethics at Quintiles G /23/ /23/2011 Course: (Archived) ELVIS Customer Project Controller Training QR /7/ /23/2011 Document: Training SOP Release 01 December Clinical QR /18/ /23/2011 Document: Training SOP Release 01 August Clinical QR /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) QR /13/2011 9/14/2011 QR /14/2011 9/14/2011 Course: (Archived) Introduction to Anti-Bribery 2011 G /2/2011 9/2/2011 Course: (Archived) Global Privacy Awareness: Basic Training 2011 G /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 QR /9/2011 8/9/2011 QR /9/2011 8/9/2011 QR /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 QR /8/2011 8/8/2011 QR /8/2011 8/8/2011 Structure Change Date:9/27/2010 ILT Course: Clinical Files: Setup, Maintenance and Archiving M /30/2011 6/30/2011 ILT Class: Clinical Files: Setup, Maintenance and Archiving M /30/2011 6/30/2011 Course: (Archived)Introduction to the Anti-kickback Statute and False Claims Act G /28/2011 4/28/2011 Versional: US Employee Handbook Acknowledgement M /6/2011 4/6/2011 Course: US Employee Handbook Acknowledgement M /6/2011 4/6/2011 Structure Change Date:3/14/2013 Document: Training SOP Release 01 April Clinical QR /25/2011 3/25/2011 Course: ERES: Basic Part 11 Awareness QR /16/2011 2/16/2011 Course: Training SOP Release 01 March Clinical QR /16/2011 2/16/2011 ILT Course: Corporate Orientation for New Employees G /15/2011 2/15/2011 ILT Class: Corporate Orientation for New Employees - QOPK G /15/2011 2/15/2011 Course: HIPAA Privacy Rule & HIPAA 2 QR /16/ /16/2010 Course: (Archived) Global Privacy Awareness: Basic Training 2008 G /15/ /15/2010 Course: CTMS: Query Basics Structure Change Date:6/9/2011 Course: (Archived) CTMS: Advanced Query and Reporting G /15/ /15/2010 G /2/ /2/2010 Structure Change Date:9/3/2010 Document: (Archived) Training SOP Release 01 December Clinical QR /1/ /1/2010 Course: (Archived) Business Ethics at Quintiles G A 1 11/8/ /8/2010 Course: & Calendar Navigation & Etiquette Course (Outlook) G /8/ /8/2010 Course: Instant Messaging: Communicator G /8/ /8/2010 Course: CTMS: Overview Structure Change Date:9/8/2010 G /8/ /8/2010 Virtual Course: ICH GCP and E2A Refresher - Part 2 QR /5/ /5/2010 Virtual Class: ICH GCP and E2A Refresher - Part 2 QR /5/ /5/2010 Course: (Archived) Training SOP Release 01 October Clinical QR /4/ /4/2010 Course: InForm 4.5 to 4.6 Bridge Training QR /21/ /21/2010 Course: (Archived) CTMS: Advanced Navigation (2.0) G /1/ /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 G /30/2010 9/30/2010 M /27/2010 7/28/2010 M /27/2010 7/28/2010 Versional: ELVIS Curriculum Vitae (CV) e-learning G /21/2010 7/22/2010 Page 4 / 5

5 Course: ELVIS Curriculum Vitae (CV) e-learning G /21/2010 7/22/2010 Structure Change Date:4/16/2010 Course: (Archived) Training SOP Release 01 August Clinical QR /16/2010 7/16/2010 Course: Informatics: E-Briefcase Training QR /9/2010 7/9/2010 Course: ELVIS: Clinical Orgamizational Area Overview: Clinical Operations Staff QR /8/2010 7/9/2010 Versional: Getting Started in ELVIS - Basic (English Version) G /8/2010 7/8/2010 Course: Getting Started in ELVIS - Basic (English version) G /8/2010 7/8/2010 Structure Change Date:11/7/2012 Objective: Getting Started in ELVIS Basic G /8/2010 7/8/2010 Course: Informatics Site Start Up Application (v3.0) elearning Training QR /8/2010 7/8/2010 Course: InFORMant v1.9 Self Study Training QR /8/2010 7/8/2010 Course: Informatics General Functionality Training Version 4 QR /7/2010 7/8/2010 Course: (Archived) InForm Training QC /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 QR /7/2010 7/7/2010 G /7/2010 7/7/2010 QR /6/2010 7/7/2010 Course: Employee PeopleSoft v9 Time & Labor Training G /6/2010 7/6/2010 Course: ELVIS esop Basic User Training QR /6/2010 7/6/2010 Course: Learning Curve: Learner Role V8.2 G /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 /18/ /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 QR /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 G /15/2011 2/15/2011 CS_WI_RM050 1/31/2011 1/31/2011 8/6/2010 8/6/2010 Page 5 / 5

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