12/2/2011. Integration of s into the Trial Master File. Russell Joyce. Heath Barrowcliff Consulting Ltd. Disclaimer

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1 Integration of s into the Trial Master File Russell Joyce Director & Principal i Consultant t Heath Barrowcliff Consulting Ltd 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 2 Agenda Why focus on ? What is relevant? Which format? Which repository? Where in the etmf? Challenges Solutions Final thought Drug Information Association 3 1

2 Focus on Reliance on as primary interface internally and externally for business critical communications supplier contracts & negotiations decisions and approvals opinions and statements little regulatory guidance relating to in clinical trials problem of managing trial-related is common Common misconception that s are transitory unofficial informal but they are often documents with the same legal value as any other document. Drug Information Association 4 Definitions of a document Information (recorded in any format or medium) created, received, and maintained as evidence and information by an organisation or person, in pursuance of legal obligations or in the transaction of business (ISO : 2001) All records, in any form, (including, but not limited to, written, electronic, [etc] ) that describe or record the methods, conduct and/or results of a trial, the factors affecting a trial, and the actions taken (ICH GCP 1.22 CPMP/ICH/135/95) Essential documents individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced (ICH GCP 1.23 CPMP/ICH/135/95) Back Drug Information Association 5 Focus on A business record is determined by content, not medium organisations should consider not whether there are records in but rather which records are in s must be managed as records; and retained in accordance with statutory and regulatory guidelines retention depends on subject matter purpose content context relevance Drug Information Association 6 2

3 Determining relevance Agreements or substantial exchanges regarding: trial administration agreement (eg to proceed) protocol violations trial conduct information requiring action or compliance with instructions information raising awareness of critical issues adverse event reporting Evidence of reason for a particular course of action patient inclusion in a study decisions made in absence of supporting policy or other document exceptional/study related circumstances Drug Information Association 7 Decisions on format Native digital format (eg MS Outlook s as.msg files) captures header metadata preserves provenance and integrity ensures legal admissibility permits re-use Non-native digital it format (eg to pdf or xml)* retain header metadata where possible document the conversion process Print to hard copy* acceptable to regulators but destroys metadata and may compromise evidential weight *Copies should be certified and processes validated See Rules Governing Medicinal Products in the European Union Volume 10 Annex VI 2.2 Drug Information Association 8 Metadata A common set of message fields or message headers: To, From, Cc, Bcc, and Subject. Drug Information Association 9 3

4 Return Path: <bounce Delivery Date: Wed, 23 Nov :04: Received SPF: pass (mxbap2: domain of returnpath.bluehornet.com designates as permitted sender) client ip= ; envelope from=bounce Metadata helo=smtp.porthuron.bluehornet.com; Received: from smtp.porthuron.bluehornet.com (smtp.porthuron.bluehornet.com [ ]) by mx.kundenserver.de (node=mxbap2) with ESMTP (Nemesis) id 0LiBRz 1R7r2b2OMF 00muqX for Wed, 23 Nov :04: Return Path: <bounce X MSFBL: cnvzc2vsbebozwf0agjhcnjvd2nsawzmlmnvlnvrqhbvcnrodxjvbkjpbmrpbmdazgvmyxvsdebib3vuy2utdxnlpu09mtyzotexmzq0nti9zwnobzq9m0jbnddcm ki1mte0rtmzrdvgqzrgnuu1njkwqkm2odi=dkim Signature: v=1; a=rsa sha1; d=bluehornet.com; s=bluehornet 1.bh; c=simple/simpleq=dns/txt; t= ;h=from:subject:date:to:mime Version:Content Type;bh=Gmz2IraEcVgCsarCsbNlVTdk4/M=;b=xe9vAyOaDqoIqlsnB6x0HzRfnMKo62UQsprwrspyLnDjm4aWhdHh2bfZt7B0k5YVywGMQgT6Cc4ZoSCAAu++G2ohP5ygu DS/JdclfXPhNWAch0t0dkFwhN2ZmwUWOdVN; Received: from [ ] ([ :47575] helo=localhost.localdomain)by dc1bhmta01 (envelope from r(38597)) with ESMTPid CB/C D7DFCCE4; Wed, 23 Nov :04: Message ID: Wed, 23 Nov :00: From: "DIA Webinar Team" To: =?UTF 8?B?UnVzc2VsbCBKb3ljZQ==?= Outgoing: porthuron Subject: FDA Discusses 510(k) Process and How to Prepare for a Successful Advisory Meeting List Unsubscribe: <mailto:unsub echo43ba47b2b5114e33d5fc4f5e5690bc682@listunsub.bluehornet.com>mime Version: 1.0 Content Type: multipart/alternative;boundary=" 4eccfc83da20c MultiPart Mime Boundary"X UI Junk: AutoMaybeJunk 96 (BAY); 01:pnL/cg0r:oj13WF/3IojuYFgJfStOuDCMCGxryswkv7sn0MweYU81I3q4f5KcxvtNHYZhVlWrhnCAhNjd0KGdpYg5tiU3OtQ7nTYsicIxG5tVHQGBThkMN/T8R8sj0+Cd8e9 8Td1vxYOAYmHft0snWRtz0afHsk5+qOZ7LgskgrwormBRlC2VMUQKJti7VYmGw5Q4uYxWkErZT0gvmMX57r4zc+r0zrbv8BmbwWB9blVpvP02PPuZQAJhO8X90wYb1v/n chxdhkcrijjnjvx9ub4s71+1jw5jhreyonajoeul42l/qppu1d2offddjjtiiflqzxznenvelope To: russell@heathbarrowcliff.co.uk Header Metadata A list of the servers and Internet Protocol (IP) addresses from which a message originated and through which it travelled to reach its target destination Back Drug Information Association 10 Decisions on repository Personal native mail repository (eg MS Outlook mailbox) communications tool, not a records management application organisationally challenging multiplicity of s across fragmented repositories personal and inconsistent approach to record keeping poor visibility and information sharing exponential costs for legal discovery and legal hold least likely to be readily available upon request Shared native mail repository (eg MS Outlook mailbox) communications tool, not a records management application resource heavy to manage organisationally challenging complex routing schemes required increased traffic and multiplicity of forwarded s Drug Information Association 11 Decisions on repository Shared native file repository (eg MS Explorer) limited records management functionality inconsistent, user-defined structures and organisation possible multiplicity of s in fragmented repositories poor security and access models (Semi-)Automated archive (eg Symantec Enterprise Vault) s held in separate, largely unstructured repositories indexing based on unreliable metadata eg keyword search or broad-based generic classification eg date received or sent or radio-button classification can present search and retrieval challenges not necessarily readily available limited records management functionality Drug Information Association

5 Decisions on repository Integrated etmf solution (eg Wingspan) single source repository for all related documents consistent, user-defined structures and organisation protracted save, browse and import process potential loss of format potential inability to re-use Integrated EDRMS (eg MacroView DMF Sharepoint) full records management functionality single source repository for all related documents preview files in EDRMS while you work in Outlook drag and drop functionality to save single and multiple s with automatic capture of metadata (eg to, from, sent date/time) with automatic handling of attachments use Outlook rules to automatically save copies of s Drug Information Association 13 Decisions on location in (e)tmf (if no integrated solution) Dedicated communications section organisationally challenging unless kept in chronological order least likely to be readily available upon request Subject section eg with clinical supplies documents if related to clinical supplies provides context facilitates search and retrieve capability most likely to be readily available upon request Hybrid system some according to subject (e.g. regulatory, ethics etc) others in an additional communications section less likely to be readily available upon request Drug Information Association 14 Challenges In a recent survey of 40 clinical research organisations, the following concerns were identified as key challenges with etmf communications 100.0% 90.0% 80.0% 70.0% 60.0% 50.0% 0% 40.0% 30.0% 20.0% 10.0% 0.0% Inadequate title/subject information Inappropriate content Duplication Long trails Filing of non relevant communications None Don't know Other (please specify) Drug Information Association

6 Solutions Filing of non-relevant communications (92%) covered in slide 5 see the GCP-RMA best practice guidance on relevant communications and FAQs at Inadequate title or subject information (82%) title of message not always reflective of subject change to a meaningful title on save as YYYY-MMM-DD-HH-MM [Sender] Re [Subject] YYYY-MMM-DD-HH-MM [Principal Recipient] Re [Subject] save to EDRMS to benefit from inherited metadata establish policies for to improve filing, archiving, retrieval and automated save to standardise terminology re content and subject headers Drug Information Association 16 Solutions Long trails or strings (80%) save initial and each subsequent receipt and response content may be misinterpreted if earlier correspondence is removed recipients may be added or removed metadata is converted to plain text on reply and forward Duplication (67%) to minimise duplication use established naming conventions the GCP-RMA relevant communications guidance Inappropriate content (67%) to minimise this refer to Organisations own SOPs and guidance GCP-RMA relevant communications guidance Drug Information Association 17 Final thought The of the species is more deadly than the mail a misquote from The Female of the Species by Rudyard Kipling Drug Information Association

7 Questions Drug Information Association