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市場調查報告書

臨床實驗總檔案管理:為了保障GCP (合理臨床標準)強化文檔流程

Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices

出版商 Cutting Edge Information 商品編碼 348297
出版日期 內容資訊 英文 184 Pages
商品交期: 最快1-2個工作天內
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臨床實驗總檔案管理:為了保障GCP (合理臨床標準)強化文檔流程 Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices
出版日期: 2015年11月30日 內容資訊: 英文 184 Pages
簡介

本報告提供有效的臨床實驗總檔案管理技術的相關調查、臨床實驗總檔案及臨床實驗總檔案管理的概要與重要性、團隊結構及人力資源配置範例與最佳業務實踐、品管相關配合措施的案例、成功的建議等彙整資料。

摘要整理

臨床實驗總檔案管理

  • 調查手法
  • 資料回收
  • 臨床實驗總檔案管理:成功的五個建議

簡介:臨床實驗總檔案

為了最佳化臨床實驗總檔案管理所必要的結構建立

  • TMF管理隊結構:臨床性營運牽涉
  • 為TMF成功的標準性操作次序確立
  • 建立人員編制買入並確保成功TMF流程:TMF的認知度提高和從訓練的開始
  • TMF管理隊的人力資源配置
  • TMF的外包:義務和供應商的最新資訊

品管的配合措施的頻率和時間軸

  • 臨床實驗總檔案的品管結構建立與人力資源配置
  • 為了引導品管實行標準操作次序
  • 實行eTMF以應對法規當局的審核
目錄
Product Code: PH215

EXECUTIVE SUMMARY

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.

Generally, regulators expect sponsor- and investigator-managed documents to stand alone, without additional sponsor or investigator input. Sponsors that collaborate with CRO groups must provide additional documentation in their TMF outlining which of their TMF duties they have transferred to third-party groups. Elements that sponsors and CROs must address as part of their official TMF include:

  • Which pieces of the TMF trial sponsors and CROs own
  • TMF management standard operating procedures (SOPs), including filing practices, document indexing and applicable training requirements
  • QC SOPs, including how the sponsor will ensure that TMFs uphold industry standards
  • Archiving SOPs, outlining whether sponsors or CROs are responsible for performing records management duties

Existing regulations require life sciences teams to retain TMF files long after trials either end or are discontinued. Currently, teams must maintain archived TMFs for at least 15 years beyond study completion. Once EU Regulation 536/2014 goes into effect on May 28, 2016, life sciences teams in Europe will need to maintain TMF documents for at least 25 years after clinical trials conclude. However, the European Medicines Agency (EMA) advises trial sponsors to keep essential trial documents, such as protocols, investigator brochures and case report forms, on hand throughout product authorization.

The number and types of clinical FTEs involved with the sponsor-managed TMF vary by company. Many surveyed organizations involve an array of groups: from clinical operations to dedicated TMF management teams. Aligning these groups' activities often starts with a comprehensive set of SOPs. Generally, SOPs outline the scope of individual teams' TMF responsibilities, including document submission timelines. Standard protocols may also outline the official TMF format - paper or electronic - and map out where submitted documents should go within this file. Ideally, robust SOPs will help life sciences teams develop a final TMF that is up-to-date, accurate and thorough enough to enable trial regulators to reconstruct clinical trials, should the need arise.

Because not all clinical teams may be familiar with TMF management techniques, some life sciences organizations implement TMF training. Training sessions help companies to generate awareness and to facilitate buy-in among internal groups that may have otherwise considered TMF activities on par with administrative duties. Across the life sciences industry, teams are increasingly moving toward use of electronic trial master files, or eTMFs. These solutions, while beneficial in the long-run, may create short-term headaches for pharmaceutical and device companies. Once fully developed, these solutions will help reduce the paper associated with companies' TMF files and increase teamwide accessibility. However, teams may struggle with incorporating eTMF solutions with existing platforms and properly indexing each electronic file that they upload.

How companies organize their TMFs marks the 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.1 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.

USE OF THIS REPORT

This report's benchmarks address the changing TMF landscape with a look at best practices amid industrywide trends. Specifically, this report addresses how companies build their TMF structures: from the documents included to the teams and SOPs involved. Among its many insights, this report also provides a look at surveyed teams' quality control activities, including audit preparations.

Table of Contents

Executive Summary

Trial Master File Management

  • Study Methodology
  • Data Collection
  • Trial Master File Management: Five Recommendations for Success

An Introduction to the Trial Master File

Building the Structures Necessary to Optimize Trial Master File Management

  • TMF Management Team Structures: Involve Clinical Operations
  • Establish Standard Operating Procedures For TMF Success
  • Build Staffing Buy-In And Ensure Successful TMF Processes: Start With TMF Awareness and Training
  • TMF Management Team Staffing
  • TMF Outsourcing: Responsibilities and Vendor Updates

Quality Control Activity Frequencies and Timelines

  • Structuring and Staffing Quality Control for Trial Master File
  • Implementing Standard Operating Procedures to Guide Quality Control
  • Implement eTMF To Prepare for Regulatory Audits and Inspections

Executive Summary

Trial Master File Management

Data Collection

Trial Master File Management: Five Recommendations for Success

  • Figure E.1: Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2015)
  • Figure E.2: Average Projected Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2020)
  • Figure E.3: Use of Quality Control Standard Operating Procedure
  • Figure E.4: Process for Determining Percentage of Sponsor-Level Documents That Enter Formal QC, by Team Type
  • Figure E.5: Process for Determining Site-Level Documents That Enter Formal QC, by Team Type

An Introduction to the Trial Master File

  • Figure 1.1: Clinical Insight: The Trial Master File Landscape
  • Figure 1.2: Minimum Documentation Required by ICH Guidelines Prior to Trial Initiation
  • Figure 1.3: Minimum Documentation Required by ICH Guidelines During Clinical Trials: Part One
  • Figure 1.4: Minimum Documentation Required by ICH Guidelines During Clinical Trials: Part Two
  • Figure 1.5: Minimum Documentation Required by ICH Guidelines After Trial Ends
  • Figure 1.6: Use of Trial Master File Reference Model
  • Figure 1.7: Use of Trial Master File Reference Model, by Team Type
  • Figure 1.8: Average Likelihood of Including Specific Documents in Trial Master File: All Teams
  • Figure 1.9: Average Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2015)
  • Figure 1.10: Type of eTMF Solution Preferred by Surveyed Teams with Electronic Trial Master Files
  • Figure 1.11: Initial Costs of eTMF Solutions, by Team
  • Figure 1.12: Current and Projected Maintenance Costs of eTMF Solutions, by Team
  • Figure 1.13: Stage of eTMF Solution Development for Surveyed Teams Without Electronic Trial Master Files
  • Figure 1.14: Average Projected Distribution of Electronic and Paper-Based TMF Documents, by Team Level (2020)

Building the Structures Necessary to Optimize Trial Master File Management

TMF Management Team Structures: Involve Clinical Operations

  • Figure 2.1: Clinical Executives' Trial Master File Management Responsibilities
  • Figure 2.2: Percentage of Life Sciences Teams in Developed Markets That Involve Specific Clinical Groups in TMF Management
  • Figure 2.3: Percentage of Life Sciences Teams in Emerging Markets That Involve Specific Clinical Groups in TMF Management
  • Figure 2.4: Distribution of Trial Master File Oversight: Life Sciences Teams in Developed Markets
  • Figure 2.5: Distribution of Trial Master File Oversight: Life Sciences Teams in Emerging Markets
  • Figure 2.6: Highest Trial Master File Executive Level: Life Sciences Teams in Developed Markets
  • Figure 2.7: Highest Trial Master File Executive Level: Life Sciences Teams in Emerging Markets

Establish Standard Operating Procedures for TMF success

  • Figure 2.8: Presence of Standard Operating Procedure for TMF Management: All Surveyed Life Sciences Teams in Developed Markets
  • Figure 2.9: Presence of Standard Operating Procedure for TMF Management: All Surveyed Life Sciences Teams in Emerging Markets
  • Figure 2.10: Key Components of a Good Trial Master File Management SOP

Build Staffing Buy-In and Ensure Successful TMF Processes: Start with TMF Awareness and Training

  • Figure 2.11: Trial Master File Training Structure: Global Teams
  • Figure 2.12: Trial Master File Training Structure: US Teams
  • Figure 2.13: Trial Master File Training Structure: Country-Level Teams
  • Figure 2.14: Ownership of Trial Master File Training, by Team Level
  • Figure 2.15: Frequency of Trial Master File Training, by Team Level
  • Figure 2.16: Trial Master File Training Cost, Per Trainee

TMF Management Team Staffing

  • Figure 2.17: Number of Dedicated Trial Master File FTEs: Global Teams
  • Figure 2.18: Number of Clinical Development FTEs Responsible for TMFs: Global Teams
  • Figure 2.19: Number of Clinical Operations FTEs Responsible for TMFs: Global Teams
  • Figure 2.20: Number of Compliance FTEs Responsible for TMFs: Global Teams
  • Figure 2.21: Number of Quality Assurance FTEs Responsible for TMFs: Global Teams
  • Figure 2.22: Number of Quality Control FTEs Responsible for TMFs: Global Teams
  • Figure 2.23: Number of Regulatory Affairs FTEs Responsible for TMFs: Global Teams
  • Figure 2.24: Number of Data Management FTEs Responsible for TMFs: Global Teams
  • Figure 2.25: Number of Contract Management FTEs Responsible for TMFs: Global Teams
  • Figure 2.26: Number of Records Management FTEs Responsible for TMFs: Global Teams
  • Figure 2.27: Number of IT FTEs Responsible for TMFs: Global Teams
  • Figure 2.28: Number of Dedicated Trial Master File FTEs: US Teams
  • Figure 2.29: Number of Clinical Development FTEs Responsible for TMFs: US Teams
  • Figure 2.30: Number of Clinical Operations FTEs Responsible for TMFs: US Teams
  • Figure 2.31: Number of Quality Assurance FTEs Responsible for TMFs: US Teams
  • Figure 2.32: Number of Data Management FTEs Responsible for TMFs: US Teams
  • Figure 2.33: Number of Other FTEs Responsible for TMFs: US Teams
  • Figure 2.34: Number of Dedicated Trial Master File FTEs: Country-Level Teams
  • Figure 2.35: Number of Clinical Operations FTEs Responsible for TMFs: Country-Level Teams
  • Figure 2.36: Number of Quality Assurance FTEs Responsible for TMFs: Country-Level Teams
  • Figure 2.37: Number of Quality Control FTEs Responsible for TMFs: Country-Level Teams
  • Figure 2.38: Number of Data Management FTEs Responsible for TMFs: Country-Level Teams
  • Figure 2.39: Number of Records Management FTEs Responsible for TMFs: Country-Level Teams
  • Figure 2.40: Number of Other FTEs Responsible for TMFs: Country-Level Teams
  • Figure 2.41: Staffing Change for Dedicated TMF Group FTEs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.42: Staffing Change for Clinical Development FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.43: Staffing Change for Clinical Operations FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.44: Staffing Change for Compliance FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.45: Staffing Change for Quality Assurance FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.46: Staffing Change for Quality Control FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.47: Staffing Change for Regulatory Affairs FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.48: Staffing Change for Data Management FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.49: Staffing Change for Records Management FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.50: Staffing Change for IT FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.51: Staffing Change for Other FTEs Responsible for TMFs: Life Sciences Teams in Developed Markets (2015 to 2020)
  • Figure 2.52: Staffing Change for Clinical Operations FTEs Responsible for TMFs: Life Sciences Teams in Emerging Markets (2015 to 2020)
  • Figure 2.53: Staffing Change for Records Management FTEs Responsible for TMFs: Life Sciences Teams in Emerging Markets (2015 to 2020)
  • Figure 2.54: Staffing Change for Other FTEs Responsible for TMFs: Life Sciences Teams in Emerging Markets (2015 to 2020)

TMF Outsourcing: Responsibilities and Vendor Updates

  • Figure 2.55: Percentage of TMF Management Duties Outsourced: Global Teams
  • Figure 2.56: Percentage of TMF Management Duties Outsourced: US Teams
  • Figure 2.57: Percentage of TMF Management Duties Outsourced: Country-Level Teams
  • Figure 2.58: Trial Master File Ownership Strategy, by Team Type
  • Figure 2.59: Clinical Trial Management System Ownership Strategy, by Team Type
  • Figure 2.60: Document Management System Ownership Strategy, by Team Type
  • Figure 2.61: Frequency That Companies Expect Vendors to Provide TMF Updates, by Team Level

Quality Control Activity Frequencies and Timelines

Structuring and Staffing Quality Control for Trial Master File

  • Figure 3.1: Quality Control Ownership, by Team Level
  • Figure 3.2: Groups Involved in Quality Control: Global Teams
  • Figure 3.3: Groups Involved in Quality Control: US Teams
  • Figure 3.4: Groups Involved in Quality Control: Country-Level Teams (Developed Markets)
  • Figure 3.5: Groups Involved in Quality Control: Country-Level Teams (Emerging Markets)
  • Figure 3.6: Size of Group Supporting Formal QC Activities: Global Teams
  • Figure 3.7: Size of Group Supporting Formal QC Activities: US Teams
  • Figure 3.8: Size of Group Supporting Formal QC Activities: Country-Level Teams (Developed Markets)
  • Figure 3.9: Size of Group Supporting Formal QC Activities: Country-Level Teams (Emerging Markets)

Implementing Standard Operating Procedures to Guide Quality Control

  • Figure 3.10: Presence of Standard Operating Procedure for Quality Control: All Surveyed Life Sciences Teams
  • Figure 3.11: Use of Quality Control Standard Operating Procedure
  • Figure 3.12: Process for Determining Percentage of Sponsor-Level Documents That Enter Formal QC, by Team Type
  • Figure 3.13: Process for Determining Percentage of Site-Level Documents That Enter Formal QC, by Team Type
  • Figure 3.14: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: Global Teams
  • Figure 3.15: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: US Teams
  • Figure 3.16: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: Country-Level Teams (Developed Markets)
  • Figure 3.17: Percentage of Sponsor- and Site-Level TMF Documents That Go Through Formal QC: Country-Level Teams (Emerging Markets)
  • Figure 3.18: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: Global Teams
  • Figure 3.19: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: US Teams
  • Figure 3.20: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: Country-Level Teams (Developed Markets)
  • Figure 3.21: Percentage of Vendor-Managed TMF Documents That Enter Formal QC: Country-Level Teams (Emerging Markets)
  • Figure 3.22: Number of Times TMF Documents Enter QC, by Document Type
  • Figure 3.23: Timing of Final QC Review, by Document Type: Global Teams
  • Figure 3.24: Timing of Final QC Review, by Document Type: US Teams
  • Figure 3.25: Timing of Final QC Review, by Document Type: Country-Level Teams (Developed Markets)
  • Figure 3.26: Timing of Final QC Review, by Document Type: Country-Level Teams (Emerging Markets)
  • Figure 3.27: Quality Control Evaluation Timeline: Completeness (Global Teams)
  • Figure 3.28: Quality Control Evaluation Timeline: Completeness (US Teams)
  • Figure 3.29: Quality Control Evaluation Timeline: Completeness (Country-Level Teams)
  • Figure 3.30: Quality Control Evaluation Timeline: Accuracy (Global Teams)
  • Figure 3.31: Quality Control Evaluation Timeline: Accuracy (US Teams)
  • Figure 3.32: Quality Control Evaluation Timeline: Accuracy (Country-Level Teams)
  • Figure 3.33: Quality Control Evaluation Timeline: Presentation (Global Teams)
  • Figure 3.34: Quality Control Evaluation Timeline: Presentation (US Teams)
  • Figure 3.35: Quality Control Evaluation Timeline: Presentation (Country-Level Teams)
  • Figure 3.36: Quality Control Evaluation Timeline: Compliance (Global Teams)
  • Figure 3.37: Quality Control Evaluation Timeline: Compliance (US Teams)
  • Figure 3.38: Quality Control Evaluation Timeline: Compliance (Country-Level Teams)

Implement eTMF to Prepare for Regulatory Audits and Inspections

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