Constructing an etmf The do s and don ts of EDM Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association www.diahome.org 2 consider your current etmf structure!! Drug Information Association www.diahome.org 3 1
TMF Contributors Internal contributors Access to company s infrastructure Subject to company s written procedures External Contributors Limited or no access to company s infrastructure Are not subject to company s written procedures Drug Information Association www.diahome.org 4 etmf Experience Consider if your organisation has experience in etmf etmf handling and maintenance? Which EDMS functionalities have been implemented (usage of electronic lifecycle, naming standardisation, template management)? Drug Information Association www.diahome.org 5 TMF Governance Centralised governance model One group overseeing and enforcing written procedures for GCP related activities across the company May delegate certain activities to specialized personnel but maintain oversight Decentralised governance model Employ multiple group or departments for overseeing and enforcing written procedures without overarching governance entity No one TMF owner Drug Information Association www.diahome.org 6 2
Determining EDM Tool Requirements consider your EDMS requirements based on your outsourcing strategy!! Drug Information Association www.diahome.org 7 Determining EDM Tool Requirements Drug Information Association www.diahome.org 8 In-house Requirements Sharing TMF documentation and information across multiple countries and departments Automate filing and indexing Electronic lifecycle l and workflows Facilitate instant document retrieval Inspection readiness Drug Information Association www.diahome.org 9 3
Out-source Service Requirements Extending in-house EDM functionalities to external partners Real time access to trial documentation for both Sponsor and CRO Controlled collaboration cycles Oversight of clinical trial conduct Drug Information Association www.diahome.org 10 How to Determine Implementation of Appropriate EDM Tools believe one size fits all when considering appropriate EDMS tools!! Drug Information Association www.diahome.org 11 How to Determine Implementation of Appropriate EDM Tools A question of paper Consider the presumed benefit against the cost of the manual process E.g. assess the expected document volume to be scanned per year against the level of automation needed for a scanning integration. If the document volume does not exceed a certain volume of documents a year the necessary administration cost for a fully automated scanning solution with template recognition might far outweigh the cost of manual processing where indexing is done manually. Drug Information Association www.diahome.org 12 4
How to Determine Implementation of Appropriate EDM Tools consider metrics!! Drug Information Association www.diahome.org 13 How to Determine Implementation of Appropriate EDM Tools In-house EDM Tools An Electronic Document Management System (EDMS) A Scanning Solution/integration Out-sourced Services EDM Tools An Electronic Document Management System (EDMS) A Scanning Solution/integration Portals (CRO/Investigator) Clinical application integration Drug Information Association www.diahome.org 14 know that the success of your etmf is also dependent on your written procedures!! Drug Information Association www.diahome.org 15 5
Owning Department Establish a basic etmf governance structure Consider a centralised TMF owner BUT do include local document management personnel in the development of the etmf governance structure to accommodate local requirements Drug Information Association www.diahome.org 16 Implementing EDM Tools A way to Compliance Template Authoring Efficient when aiming to reduce paper records Ensure latest current version is used consistently throughout and organisation Auto naming Standardise naming convention across studies and departments A clean database for successful search and retrieval Electronic Lifecycles Ensure certain workflow sequences Drug Information Association www.diahome.org 17 CRO Governance Consider the procedural foundation of a CRO collaboration at a contractual level, such as: Usage of sponsor vs. CRO templates TMF structures/indexing methods Access to sponsor s or CRO clinical portal solutions Schedule and delivery format of TMF documentation Drug Information Association www.diahome.org 18 6
allow users to circumvent your written procedures!! Drug Information Association www.diahome.org 19 Implementing etmf consider the right balance between just enough and too much information!! Drug Information Association www.diahome.org 20 Implementing etmf etmf Inventory Must accommodate a structure that allows users to quickly access the necessary documents Consider the number of document expected to appear within a single folder Consider using industry references like the DIA TMF Reference Model for standardisation di ti Metadata Aim for a balance of differentiation - using not only the right metadata but relevant metadata is the goal. Naming Standards Necessary for large volumes of documentation not only for the purpose of retrieval but also for overview and evaluation and longterm migration possibilities Drug Information Association www.diahome.org 21 7
End Point remember that the etmf to be ever evolving!! Drug Information Association www.diahome.org 22 End Point remember to maintain and reassess continuously during etmf development!! Drug Information Association www.diahome.org 23 End Point remember the TMF is TOO MUCH FUN!! Drug Information Association www.diahome.org 24 8