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Template The template includes green text which is there to provide guidance to the user on how to best adapt the TMF Plan depending on the type, size, complexity of the clinical trial. As such, it should be taken as a recommendation on how the template can be used, rather than how it should be used. Users of the template are highly encouraged to adapt
Category: Trial master file plan template Preview / Show details
Pocket TMF Plan Template: Suggested structure and outline for a Trial Master File Plan (v1.0 Approved 23-February 2018) eTMF Selection – Request for Proposal Template (co-authored by Scientific Archivists Group, TMF Reference Model and Pocket EDMS, March 2017
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Implementation This eTMF Implementation Checklist is a quick-start guide which provides a list of questions to ask and ideas to consider when creating an eTMF Implementation plan. Use it to get started when looking for eTMF solutions, to integrate into your own planning documents, or simply to look for ways to improve your existing TMF processes.
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Download Download our eTMF Implementation Checklist. and get a head start. This checklist provides you with a helpful guide as you work through. your eTMF (Electronic Trial Master File) process. Areas that are covered include: TMF Content, TMF Quality, TMF Oversight, Reporting, Roles & Responsibilities, and more. Free Download Free Download.
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Recovery The eTMF shall have complete system and content backup and restore plan as well as a complete disaster recovery plan. The eTMF shall provide high availability and fail over for business continuity. The eTMF vendor shall provide a complete disaster recovery plan. The eTMF vendor shall provide recovery point and recovery time objectives (RTO/RPO
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Document An eTMF-structured checklist template that is designed in alignment with the DIA TMF Reference Model. An integrated, out-of-the-box document management configuration of TMF document types, templates, metadata, version control, lifecycle management, routes, and user roles for all electronic trial master file artifacts
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Should When a CRO is used for the management of the eTMF and/or for the digitisation/transfer of TMF documents, appropriate pre-qualification checks should be undertaken prior to contracting the CRO. It should be verified during the clinical trial that the CRO’s quality management measures are complied with. 3.3.
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Regulatory A clinical trial master file (TMF) is an essential collection of the many documents, tasks, milestones and activities that must be maintained as evidence of scientific credibility and proof of a clinical trial’s adherence to regulatory requirements. A trial master file checklist can help ensure that the content required for regulatory
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Trial Creation and Maintenance of Trial Master File. The Medicines for Human Use (Clinical Trails) Regulations state that clinical trials will be conducted according to the principles of Good Clinical Practice.. Regulation 31A requires that a readily available Trial Master File is kept, which contains the essential documents relating to that clinical trial. In addition to demonstrating compliance
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Oversight Vendor Oversight Plan Template 1. Cover Page 2. Introduction 3. Study Contacts 4. Governance 5. Staff Qualification & Selection 6. Team Training 7. Oversight Activities & Responsibilities 8. Feedback: Performance and Quality 9. Oversight of Vendor Sub-Contractors 10. Communication Plan 11. Risk Management Plan 12. Effectiveness Checks 13
System What type of eTMF solution did you most recently use? (n=135, Q.9) Sponsor company responses only. 13%13% 26% 18% 30% N/A, only use paper Local file system Cloud file share Content mgmt. system eTMF Application Only half of electronic models use eTMFs with advanced process management Source: Veeva 2015 Paperless TMF Survey
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Practices Tools & Downloads. DIA Communities have developed a number of tools, information, case studies and best practices to help you in your jobs, taking advantage of best practices in real-world settings, vetted by an inter-disciplinary group of subject matter experts. Regulatory Information Management (RIM) Whitepaper V2.0.
Central eTMF Systems 2.1 Study File Index 2.2 Protocol & Amendments 2.3 Case Report Forms 2.4 Model Informed Consent 2.5 Investigators 2.6 IMP and Related Supplies 2.7 Biostatistics 2.8 Clinical Trial Insurance 2.9 Central IRB/IEC 2.10 Central Lab 2.11 Project Management 2.12 CRO/Vendor 2.13 IXRS 2.14 Manuals/Tools 2.15 Audit and Compliance
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Tired Tired of paying your ETMF vendor to customize your ETMF model? SureDesigner lets you quickly modify your electronic trial master file plan to meet your needs. Add standards-based tags to facilitate automated classification, search and reporting. When you are done, save your filing plan as a reusable template.
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Templates Some eTMF providers use an approach of defining a few types of templates for trial-specific TMFs; but when one considers the dozens of factors that influence document requirements, this would result in the need for hundreds or thousands of templates, which would not be maintainable. Thus, templates can provide only
Research Learn what Capabilities an eTMF Needs to Power Your Clinical Operations Effectively. In this free eTMF capabilities and evaluation checklist, you'll get insights into what features and functionality you should look for in an eTMF for your clinical trial operations. Compiled from working with hundreds of sponsors, CROs, and research sites. In this capability …
Stored fined in the TMF plan or TMF index. Ancillary Systems Review your TMF index to ensure it covers all TMF content, whether stored in the core eTMF or in ancillary (including vendor) systems If content is stored in vendor systems, clearly define how it will be transferred and archived at the end of a trial, and how it will be ac-
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The TMF template is based on the TMF Reference Model Version 3.0, which was released by the Drug Information Association’s TMF Working Group in June 2015. A TMF software solution can facilitate the real-time management of a trial master file checklist and improve visibility into the status of all TMF activities.
Overview of Integration Between CTMS and eTMF An electronic trial master file (eTMF) is a content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for clinical trials that may be required for compliance with government regulatory agencies.
The template includes green text which is there to provide guidance to the user on how to best adapt the TMF Plan depending on the type, size, complexity of the clinical trial. As such, it should be taken as a recommendation on how the template can be used, rather than how it should be used.
You can download this free of charge from our Resources web page. The purpose of a TMF Plan is to leverage TMF expectations between sponsors and relevant TMF stakeholders (e.g., CROs/vendors) to ensure delivery of a high quality TMF, and that what is expected from all concerned parties (CROs, vendors and sponsors) is clearly defined.