Trial Master File Benchmarking Data

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Cutting Edge Information surveyed clinical research and development executives involved with or with knowledge of their companies trial master file (TMF) operations. The following charts present trial master file benchmarking data collected from more than 60 TMF executives around the world.

Trial Master File Benchmarking Data

The trial master file benchmarking data in this document will show you how companies organize their TMFs marks to make difference between a successful and less-than-successful regulatory audit. A recent EMA paper highlighted the more common pitfalls companies experience when managing their TMF documents. Problematic audit findings often center on the TMF structure, including:

  • Key documents missing, such as SOP-related materials or those outlining breakdown of sponsor and CRO responsibilities
  • Unnecessarily repeated documents
  • Improper or inconsistent indexing in which either provided links did not yield the appropriate document or sponsor teams were unable to direct regulators to requested materials

Consistent quality control procedures can resolve many of the aforementioned problems that emerge during regulatory inspections.  This data packet will provide you key trial master file benchmarking data that will guide your TMF processes and resources.

Top Reasons to Buy this Trial Master File Benchmarking Data Report

Guide Quality Control Efforts before Finalizing Trial Master Files:  TMFs contain a wide array of materials — all of which need to be kept up-to-date, accurate and complete. Use the trial master file benchmarking data in this file to create SOPs to ensure quality control in advance of regulatory audits or inspections. Use Trial Master File Benchmarking Data to develop metrics around document submissions and ease the burden for the document storage and archiving groups.

Compare Trial Master File Benchmarking Data to Develop Milestones for Document Submissions:  Clinical groups sometimes delay TMF submissions because they are preoccupied with other trial activities.  Use this trial master file benchmarking analysis to find out the key milestones for submitting TMF documents.

Keep Pace with Industry Projections for Electronic TMF documentation: What percentage of your TMF documents are stored electronically?  This trial master file benchmarking analysis 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.

Excerpt from Trial Master File Benchmarking Data:

Trial Master File Benchmarking Data Contents:

Executive Summary

  • Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2015)
  • Average Projected Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2020)
  • Use of Quality Control Standard Operating Procedure
  • Process for Determining Percentage of Sponsor-Level Documents That Enter Formal QC, by Team Type
  • Process for Determining Percentage of Site-Level Documents That Enter Formal QC, by Team Type

Chapter 1: An Introduction to the Trial Master File

  • Clinical Insight: The Trial Master File Landscape
  • Minimum Documentation Required by ICH Guidelines Prior to Trial Initiation
  • Minimum Documentation Required by ICH Guidelines During Clinical Trials
  • Minimum Documentation Required by ICH Guidelines After Trial Ends
  • Use of Trial Master File Reference Model
  • Use of Trial Master File Reference Model, by Team Type
  • Average Likelihood of Including Specific Documents in Trial Master File: All Teams
  • Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2015)
  • Type of eTMF Solution Preferred by Surveyed Teams with Electronic Trial Master Files
  • Initial Costs of eTMF Solutions, by Team
  • Current and Projected Maintenance Costs of eTMF Solutions, by Team
  • Stage of eTMF Solution Development for Surveyed Teams Without Electronic Trial Master Files
  • Average Projected Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2020)

Chapter 2: Building the Structures Necessary to Optimize Trial Master File Management

  • Clinical Executives’ Trial Master File Management Responsibilities
  • Percentage of Life Sciences Teams That Involve Specific Clinical Groups in TMF Management
    • Developed Markets
    • Emerging Markets
  • Distribution of Trial Master File Oversight
    • Developed Markets
    • Emerging Markets
  • Highest Trial Master File Executive Level: Life Sciences Teams in Developed Markets
  • Highest Trial Master File Executive Level: Country-Level Life Sciences Teams in Emerging Markets
  • Presence of Standard Operating Procedure for TMF Management
    • Developed Markets
    • Emerging Markets
  • Key Components of a Good Trial Master File Management SOP
  • Trial Master File Training Structure
    • Global Teams
    • US Teams
    • Country-Level Teams
  • Ownership of Trial Master File Training, by Team Level
  • Frequency of Trial Master File Training, by Team Level
  • Trial Master File Training Cost, Per Trainee
  • Number of Dedicated Trial Master File FTEs: Global Teams
  • Global Team FTEs Responsible for TMFs
    • Clinical Development FTEs
    • Clinical Operations FTEs
    • Compliance FTEs
    • Quality Assurance FTEs
    • Quality Control FTEs
    • Regulatory Affairs FTEs
    • Data Management FTEs
    • Contract Management FTEs
    • Records Management FTEs
    • IT FTEs
  • US Team FTEs Responsible for TMFs
    • Clinical Development FTEs
    • Clinical Operations FTEs
    • Quality Assurance FTEs
    • Data Management FTEs
    • Other FTEs
  • Country-Level Team FTEs Responsible for TMFs
    • Clinical Operations FTEs
    • Quality Assurance FTEs
    • Qiality Control FTEs
    • Data Management FTEs
    • Records Management FTEs
    • Other FTEs
  • Staffing Change for Dedicated TMF Group FTEs: Life Sciences Teams in Developed Markets (2015 to 2020)
    • Clinical Development FTEs
    • Clinical Operations FTEs
    • Compliance FTEs
    • Quality Assurance FTEs
    • Quality Control FTEs
    • Regulatory Affairs FTEs
    • Data Management FTEs
    • Records Management FTEs
    • IT FTEs
    • Other FTEs
  • Staffing Change for TMF Group FTEs: Life Sciences Teams in Emerging Markets (2015 to 2020)
    • Clinical Operations FTEs
    • Records Management FTEs
    • Other FTEs
  • Percentage of TMF Management Duties Outsourced
    • Global Teams
    • US Teams
    • Country-Level Teams
  • Trial Master File Ownership Strategy, by Team Type
  • Clinical Trial Management System Ownership Strategy, by Team Type
  • Document Management System Ownership Strategy, by Team Type
  • Frequency That Companies Expect Vendors to Provide TMF Updates, by Team Level

Chapter 3: Quality Control Activity Frequencies and Timelines

  • Quality Control Ownership, by Team Level
  • Groups Involved in Quality Control
    • Global Teams
    • US Teams
    • Country-Level Teams (Developed Markets)
    • Country-Level Teams (Emerging Markets)
  • Size of Group Supporting Formal QC Activities
    • Global Teams
    • US Teams
    • Country-Level Teams (Developed Markets)
    • Country-Level Teams (Emerging Markets)
  • Presence of Standard Operating Procedure for Quality Control: All Surveyed Life Sciences Teams
  • Use of Quality Control Standard Operating Procedure
  • Process for Determining Percentage of Sponsor-Level Documents That Enter Formal QC, by Team Type
  • Process for Determining Percentage of Site-Level Documents That Enter Formal QC, by Team Type
  • Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC
    • Global Teams
    • US Teams
    • Country-Level Teams (Developed Markets)
    • Country-Level Teams (Emerging Markets)
  • Percentage of Vendor-Managed TMF Documents That Enter Formal QC
    • Global Teams
    • US Teams
    • Country-Level Teams (Developed Markets)
    • Country-Level Teams (Emerging Markets)
  • Number of Times TMF Documents Enter QC, by Document Type
  • Timing of Final QC Review, by Document Type
    • Global Teams
    • US Teams
    • Country-Level Teams (Developed Markets)
    • Country-Level Teams (Emerging Markets)
  • Quality Control Evaluation Timeline: Completeness (Global, US and Country-Level Teams)
  • Quality Control Evaluation Timeline: Accuracy (Global, US and Country-Level Teams)
  • Quality Control Evaluation Timeline: Presentation (Global, US and Country-Level Teams)
  • Quality Control Evaluation Timeline: Compliance (Global, US and Country-Level Teams)

You may also be interested in CEIConnect: The Lifesciences Industry’s On-Demand Research Resource  as well as our individual clinical development research reports.

Partial list of companies that participated in Trial Master File Benchmarking Data:

Trial Master File Management Study Participation List