FULL TABLE OF CONTENTS AND CHARTS & GRAPHICS

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1 TRIAL MASTER FILE MANAGEMENT UPHOLD DOCUMENTATION PROCESSES TO SAFEGUARD GOOD CLINICAL PRACTICES FULL TABLE OF CONTENTS AND CHARTS & GRAPHICS 68 T.W. Alexander Dr. P.O. Box Research Triangle Park, NC TM WE ANSWER QUESTIONS THAT NO ONE ELSE CAN.

2 8 Executive Summary 8 Trial Master File Management 11 Study Methodology 11 Data Collection 15 Trial Master File Management: Five Recommendations for Success 24 An Introduction to the Trial Master File 58 Building the Structures Necessary to Optimize Trial Master File Management 60 TMF Management Team Structures: Involve Clinical Operations 71 Establish Standard Operating Procedures For TMF Success 79 Build Staffing Buy-In And Ensure Successful TMF Processes: Start With TMF Awareness and Training 90 TMF Management Team Staffing 133 TMF Outsourcing: Responsibilities and Vendor Updates 142 Quality Control Activity Frequencies and Timelines 143 Structuring and Staffing Quality Control for Trial Master File 152 Implementing Standard Operating Procedures to Guide Qualtiy Control 181 Implement etmf To Prepare for Regulatory Audits and Inspections

3 8 Executive Summary 8 Trial Master File Management 11 Data Collection 15 Trial Master File management: Five Recommendations for Success 16 Figure E.1: Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2015) 16 Figure E.2: Projected Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2020) 20 Figure E.3: Use of Quality Control Standard Operating Procedure 21 Figure E.4: Process for Determining Percentage of Sponsor-Level Documents That Enter Formal QC, by Team Type 21 Figure E.5: Process for Determining Site-Level Documents That Enter Formal QC, by Team Type 24 An Introduction to the Trial Master File 25 Figure 1.1: Clinical Insight: The Trial Master File Landscape 27 Figure 1.2: Minimum Documentation Required by ICH Guidelines Prior to Trial Initiation 28 Figure 1.3: Minimum Documentation Required by ICH Guidelines During Clinical Trials: Part One 29 Figure 1.4: Minimum Documentation Required by ICH Guidelines During Clinical Trials: Part Two 30 Figure 1.5: Minimum Documentation Required by ICH Guidelines After Trial Ends 33 Figure 1.6: Use of Trial Master File Reference Model 34 Figure 1.7: Use of Trial Master File Reference Model, by Team Type 37 Figure 1.8: Average Likelihood of Including Specific Documents in Trial Master File: All Teams 39 Figure 1.9: Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2015) 40 Figure 1.10: Type of etmf Solution Preferred by Surveyed Teams with Electronic Trial Master Files 41 Figure 1.11: Initial Costs of etmf Solutions, by Team 42 Figure 1.12: Current and Projected Maintenance Costs of etmf Solutions, by Team 44 Figure 1.13: Stage of etmf Solution Development for Surveyed Teams Without Electronic Trial Master Files 55 Figure 1.14: Average Projected Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2020)

4 58 Building the Structures Necessary to Optimize Trial Master File Management 60 TMF Management Team Structures: Involve Clinical Operations 61 Figure 2.1: Clinical Executives Trial Master File Management Responsibilities 63 Figure 2.2: Percentage of Life Sciences Teams in Developed Markets That Involve Specific Clinical Groups in TMF Management 65 Figure 2.3: Percentage of Life Sciences Teams in Emerging Markets That Involve Specific Clinical Groups in TMF Management 67 Figure 2.4: Distribution of Trial Master File Oversight: Life Sciences Teams in Developed Markets 68 Figure 2.5: Distribution of Trial Master File Oversight: Life Sciences Teams in Emerging Markets 70 Figure 2.6: Highest Trial Master File Executive Level: Life Sciences Teams in Developed Markets 70 Figure 2.7: Highest Trial Master File Executive Level: Life Sciences Teams in Emerging Markets 71 Establish Standard Operating Procedures for TMF success 71 Figure 2.8: Presence of Standard Operating Procedure for TMF Management: All Surveyed Life Sciences Teams in Developed Markets 72 Figure 2.9: Presence of Standard Operating Procedure for TMF Management: All Surveyed Life Sciences Teams in Emerging Markets 74 Figure 2.10: Key Components of a Good Trial Master File Management SOP 79 Build Staffing Buy-In and Ensure Successful TMF Processes: Start with TMF Awareness and Training 84 Figure 2.11: Trial Master File Training Structure: Global Teams 84 Figure 2.12: Trial Master File Training Structure: US Teams 85 Figure 2.13: Trial Master File Training Structure: Country-Level Teams 87 Figure 2.14: Ownership of Trial Master File Training, by Team Level 88 Figure 2.15: Frequency of Trial Master File Training, by Team Level 89 Figure 2.16: Trial Master File Training Cost, Per Trainee 90 TMF Management Team Staffing 92 Figure 2.17: Number of Dedicated Trial Master File FTEs: Global Teams 93 Figure 2.18: Number of Clinical Development FTEs Responsible for TMFs: Global Teams 94 Figure 2.19: Number of Clinical Operations FTEs Responsible for TMFs: Global Teams 95 Figure 2.20: Number of Compliance FTEs Responsible for TMFs: Global Teams 96 Figure 2.21: Number of Quality Assurance FTEs Responsible for TMFs: Global Teams 97 Figure 2.22: Number of Quality Control FTEs Responsible for TMFs: Global Teams 98 Figure 2.23: Number of Regulatory Affairs FTEs Responsible for TMFs: Global Teams 99 Figure 2.24: Number of Data Management FTEs Responsible for TMFs: Global Teams 100 Figure 2.25: Number of Contract Management FTEs Responsible for TMFs: Global Teams 101 Figure 2.26: Number of Records Management FTEs Responsible for TMFs: Global Teams 102 Figure 2.27: Number of IT FTEs Responsible for TMFs: Global Teams

5 103 Figure 2.28: Number of Dedicated Trial Master File FTEs: US Teams 104 Figure 2.29: Number of Clinical Development FTEs Responsible for TMFs: US Teams 105 Figure 2.30: Number of Clinical Operations FTEs Responsible for TMFs: US Teams 106 Figure 2.31: Number of Quality Assurance FTEs Responsible for TMFs: US Teams 107 Figure 2.32: Number of Data Management FTEs Responsible for TMFs: US Teams 108 Figure 2.33: Number of Other FTEs Responsible for TMFs: US Teams 109 Figure 2.34: Number of Dedicated Trial Master File FTEs: Country-Level Teams 110 Figure 2.35: Number of Clinical Operations FTEs Responsible for TMFs: Country-Level Teams 111 Figure 2.36: Number of Quality Assurance FTEs Responsible for TMFs: Country-Level Teams 112 Figure 2.37: Number of Quality Control FTEs Responsible for TMFs: Country-Level Teams 114 Figure 2.38: Number of Data Management FTEs Responsible for TMFs: Country-Level Teams 114 Figure 2.39: Number of Records Management FTEs Responsible for TMFs: Country-Level Teams 115 Figure 2.40: Number of Other FTEs Responsible for TMFs: Country-Level Teams 117 Figure 2.41: Staffing Change for Dedicated TMF Group FTEs: Life Sciences Teams in Developed 118 Figure 2.42: Staffing Change for Clinical Development FTEs Responsible for TMFs: Life Sciences Teams in 119 Figure 2.43: Staffing Change for Clinical Operations FTEs Responsible for TMFs: Life Sciences Teams in 120 Figure 2.44: Staffing Change for Compliance FTEs Responsible for TMFs: Life Sciences Teams in 121 Figure 2.45: Staffing Change for Quality Assurance FTEs Responsible for TMFs: Life Sciences Teams in 122 Figure 2.46: Staffing Change for Quality Control FTEs Responsible for TMFs: Life Sciences Teams in 123 Figure 2.47: Staffing Change for Regulatory Affairs FTEs Responsible for TMFs: Life Sciences Teams in 124 Figure 2.48: Staffing Change for Data Management FTEs Responsible for TMFs: Life Sciences Teams in 125 Figure 2.49: Staffing Change for Records Management FTEs Responsible for TMFs: Life Sciences Teams in 126 Figure 2.50: Staffing Change for IT FTEs Responsible for TMFs: Life Sciences Teams in Developed 127 Figure 2.51: Staffing Change for Other FTEs Responsible for TMFs: Life Sciences Teams in Developed 129 Figure 2.52: Staffing Change for Clinical Operations FTEs Responsible for TMFs: Life Sciences Teams in Emerging 130 Figure 2.53: Staffing Change for Records Management FTEs Responsible for TMFs: Life Sciences Teams in Emerging 131 Figure 2.54: Staffing Change for Other FTEs Responsible for TMFs: Life Sciences Teams in Emerging

6 133 TMF Outsourcing: Responsibilities and Vendor Updates 134 Figure 2.55: Percentage of TMF Management Duties Outsourced: Global Teams 135 Figure 2.56: Percentage of TMF Management Duties Outsourced: US Teams 135 Figure 2.57: Percentage of TMF Management Duties Outsourced: Country-Level Teams 137 Figure 2.58: Trial Master File Ownership Strategy, by Team Type 138 Figure 2.59: Clinical Trial Management System Ownership Strategy, by Team Type 139 Figure 2.60: Document Management System Ownership Strategy, by Team Type 141 Figure 2.61: Frequency That Companies Expect Vendors to Provide TMF Updates, by Team Level 142 Quality Control Activity Frequencies and Timelines 143 Structuring and Staffing Quality Control for Trial Master File 144 Figure 3.1: Quality Control Ownership, by Team Level 146 Figure 3.2: Groups Involved in Quality Control: Global Teams 146 Figure 3.3: Groups Involved in Quality Control: US Teams 147 Figure 3.4: Groups Involved in Quality Control: Country-Level Teams (Developed Markets) 147 Figure 3.5: Groups Involved in Quality Control: Country-Level Teams (Emerging Markets) 149 Figure 3.6: Size of Group Supporting Formal QC Activities: Global Teams 150 Figure 3.7: Size of Group Supporting Formal QC Activities: US Teams 150 Figure 3.8: Size of Group Supporting Formal QC Activities: Country-Level Teams (Developed Markets) 151 Figure 3.9: Size of Group Supporting Formal QC Activities: Country-Level Teams (Emerging Markets) 152 Implementing Standard Operating Procedures to Guide Qualtiy Control 154 Figure 3.10: Presence of Standard Operating Procedure for Quality Control: All Surveyed Life Sciences Teams 155 Figure 3.11: Use of Quality Control Standard Operating Procedure 157 Figure 3.12: Process for Determining Percentage of Sponsor-Level Documents That Enter Formal QC, by Team Type 158 Figure 3.13: Process for Determining Percentage of Site-Level Documents That Enter Formal QC, by Team Type 160 Figure 3.14: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: Global Teams 160 Figure 3.15: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: US Teams 161 Figure 3.16: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: Country-Level Teams (Developed Markets) 161 Figure 3.17: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: Country-Level Teams (Emerging Markets) 162 Figure 3.18: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: Global Teams

7 163 Figure 3.19: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: US Teams 163 Figure 3.20: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: Country-Level Teams (Developed Markets) 164 Figure 3.21: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: Country-Level Teams (Emerging Markets) 165 Figure 3.22: Number of Times TMF Documents Enter QC, by Document Type 167 Figure 3.23: Timing of Final QC Review, by Document Type: Global Teams 167 Figure 3.24: Timing of Final QC Review, by Document Type: US Teams 168 Figure 3.25: Timing of Final QC Review, by Document Type: Country-Level Teams (Developed Markets) 168 Figure 3.26: Timing of Final QC Review, by Document Type: Country-Level Teams (Emerging Markets) 170 Figure 3.27: Quality Control Evaluation Timeline: Completeness (Global Teams) 170 Figure 3.28: Quality Control Evaluation Timeline: Completeness (US Teams) 171 Figure 3.29: Quality Control Evaluation Timeline: Completeness (Country-Level Teams) 173 Figure 3.30: Quality Control Evaluation Timeline: Accuracy (Global Teams) 173 Figure 3.31: Quality Control Evaluation Timeline: Accuracy (US Teams) 174 Figure 3.32: Quality Control Evaluation Timeline: Accuracy (Country-Level Teams) 175 Figure 3.33: Quality Control Evaluation Timeline: Presentation (Global Teams) 176 Figure 3.34: Quality Control Evaluation Timeline: Presentation (US Teams) 176 Figure 3.35: Quality Control Evaluation Timeline: Presentation (Country-Level Teams) 177 Figure 3.36: Quality Control Evaluation Timeline: Compliance (Global Teams) 178 Figure 3.37: Quality Control Evaluation Timeline: Compliance (US Teams) 178 Figure 3.38: Quality Control Evaluation Timeline: Compliance (Country-Level Teams) 181 Implement etmf to Prepare for Regulatory Audits and Inspections