Trial Master File Management

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Use this study to examine existing TMF practices, such as the scope of teams’ involvement, best practices for TMF oversight and quality control activities and companies’ transition from paper-based to eTMF platforms.

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REPORT VITALS AND FEATURES 

This report examines existing TMF practices, such as the scope of teams’ involvement, best practices for TMF oversight and quality control activities and companies’ transitions from paper-based to eTMF platforms including:

  • Pilot programs and timing of planned electronic transitions
  • Which documents (if any) remain paper
  • How companies may work with clinical storage warehouses to facilitate the transition between paper and electronic files

Data have been split by team region:

  • Global
  • US
  • Country-Level

Data have also been split by company size:

  • Top 10
  • Top 50
  • Small
  • Device

Top Reasons to Buy This Trial Master File Management Report

CREATE STANDARD OPERATING PROCEDURES TO GUIDE QUALITY CONTROL EFFORTS BEFORE FINALIZING TRIAL MASTER FILES: Standard operating procedures are essential to successful quality control systems within TMF groups. TMFs contain a wide array of materials — all of which need to be kept up-to-date, accurate and complete. SOPs ensure that quality control stakeholders have evaluated an adequate number of documents in advance of regulatory audits or inspections. Use Trial Master File Management to encourage timely document submissions and ease the burden for the document storage and archiving groups.

DEVELOP TMF MILESTONES TO ENSURE TIMELY DOCUMENT SUBMISSIONS: The TMF’s goal is to archive a clinical trial’s story in real time — meaning that groups submit documents as soon as they are ready. While this goal sounds simple enough, clinical groups sometimes delay TMF submissions because they are preoccupied with other trial activities. Investigator sites — which are responsible for a large portion of TMF documents — often prioritize collecting and managing data over paperwork. Use this report to develop milestones in the TMF SOPs that ensure timely document submissions.

CONVERT PAPER TMF DOCUMENTS INTO ELECTRONIC FORMATS TO KEEP PACE WITH INDUSTRY PROJECTIONS: Life science companies are increasing the percentage of electronic documents included in their TMF files. Moreover, surveyed teams project this trend to continue within the next three to five years. Consider implementing electronic platforms to reduce the amount of paper storage needed, increase teamwide accessibility to essential materials, and reduce inspection challenges. This report investigates the type of eTMF solution preferred by surveyed teams with electronic trial master files; the initial costs associated with eTMF solutions, by team; the average projected distribution of electronic and paper-based TMF documents and more.

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource

Excerpt from Trial Master File Management

Clinical teams leverage a series of materials known as the trial master file (TMF) to document the progression of clinical studies. TMF documents are useful from both regulatory and clinical oversight perspectives. Regulators consult teams’ TMFs to assess sponsors’ compliance with good clinical practices (GCP) and applicable legislation. Clinical trial teams use TMFs to track trial progression and promote interteam accountability.

The TMF has two components. The first is a document managed by trial sponsors and contract research organizations (CROs). The second is a document managed by trial site investigators, known as the investigator site file, or ISF. Each of these comprehensive files contains information relevant to clinical studies. The ISF may include additional site-exclusive elements, such as materials that could lead to patient re-identification.

Examples of companies that have participated in this study:

Trial Master File Management Study Participation List

Table of Contents

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 Quality Control

181        Implement eTMF To Prepare for Regulatory Audits and Inspections

CHARTS AND GRAPHICS

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 (2018)

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)

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

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 Markets (2015 to 2020)

118         Figure 2.42: Staffing Change for Clinical Development FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

119         Figure 2.43: Staffing Change for Clinical Operations FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

120         Figure 2.44: Staffing Change for Compliance FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

121         Figure 2.45: Staffing Change for Quality Assurance FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

122         Figure 2.46: Staffing Change for Quality Control FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

123         Figure 2.47: Staffing Change for Regulatory Affairs FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

124         Figure 2.48: Staffing Change for Data Management FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

125         Figure 2.49: Staffing Change for Records Management FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

126         Figure 2.50: Staffing Change for IT FTEs Responsible for TMFs: Life Sciences Teams in Developed  Markets (2015 to 2020)

127         Figure 2.51: Staffing Change for Other FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)

129         Figure 2.52: Staffing Change for Clinical Operations FTEs Responsible for TMFs: Life Sciences Teams in Emerging Markets (2015 to 2020)

130         Figure 2.53: Staffing Change for Records Management FTEs Responsible for TMFs: Life Sciences   Teams in Emerging Markets (2015 to 2020)

131         Figure 2.54: Staffing Change for Other FTEs Responsible for TMFs: Life Sciences Teams in Emerging Markets (2015 to 2020)

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 Quality 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

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