Building an etmf on Documentum. Sanofi-Pasteur s experience

Transcription

1 Building an etmf on Documentum Béatrice Neyret Director and Global Head, Clinical Documentation Sanofi-Pasteur Momentum Berlin, November 2,

2 Agenda Introduction What is the TMF? The TMF at Sanofi-Pasteur Our etmf Tool Our TMF filing Model The etmf process and actors at Sanofi-pasteur Tour of Clinical edoc The Implemetation of an etmf at Sanofi pasteur Sucess factors Next Steps Conclusion 2

3 Introduction 3

4 Definition of the TMF ICH E6 section 8 defines the Trial Master File as the mandatory sponsor dossier containing all essential documents which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated by the Regulatory Agencies. «the TMF is the only proof that remains of our work» Essential documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. The TMF of a trial is inspectable at anytime by health authorities (but generally at the time of submission of a new drug application). Documents requested by inspectors are to be provided in a timely fashion The TMF should allow to reconstruct the story of the trial several years after it took place 4

5 The TMF at Sanofi-pasteur ICH GCP does NOT provide a comprehensive contents list Each sponsor is left to work out what to include Sanofi-Pasteur has defined 12 years ago its list of TMF documents and their filing model called the Global File List (GFL) In April 2009, sanofi pasteur has migrated to an etmf. For any new study starting after this date, the TMF documents of reference in case of audit/inspection are the electronic documents created or provided by the clinical team. For paper-native documents, the paper document is kept after scanning in order to demonstrate that the electronic document is the exact copy of the original For electronic-native document, no paper version is printed for archiving. 5

6 Our etmf Tool: Clinical edoc To manage all documents, including the TMF ones, sanofi pasteur uses an Electronic Document Management System called Clinical edoc Clinical edoc has two main purposes: Allow for the entire document lifecycle in compliance with regulatory requirements and company SOPs : Document creation, import, review and approval Clinical edoc enables the versioning of documents Maintenance of Templates Allow for the etmf Management: once approved, and if applicable, the document needs to be submitted to the etmf through a TMF workflow within Clinical edoc. The documents can have the following TMF Statuses in Clinical edoc TMF Yes To Be Defined TMF Pending TMF N/A TMF Reject = Official TMF Documents in the system (auditable, inspectable documents) 6

7 Clinical edoc Clinical edoc two areas: the Document working area and the etmf area Document Working Area Documents with TMF Status To Be Defined etmf Auditable, Inspectable Documents with TMF Status N/A Documents with TMF Status Pending Document with TMF Status Yes Documents with TMF Status Rejected 7

8 The Global File List The Global File List is Sanofi-Pasteur filing model and the list of all the documents that can be created within Clinical edoc (whether TMF documents or not) The GFL serves as: A guideline on Clinical Documents management for TMF contributors. It provides the definition of the Documents and Instructions about the documents management Whether or not it should be submitted to the TMF Titles conventions Document Category which defines the need to launch a review and approval workflow Whether access to the document should be restricted to «internal only» (not accessible by external users) Responsible function and role for the document The configuration tool for Clinical edoc (for the display of pick-list, for documents properties to be pre-completed when documents is created, etc..) 8

9 The etmf Process and Actors at sanofi-pasteur 9

10 The TMF actors TMF Contributors ClinDoc Platform TMF Rep TMF contributors are any staff involved in the conduct of the clinical Trial. TMF contributors are sanofi-pasteur staff but could also be CRO staff as platforms delegate tasks to CROs ClinDoc are staff from the Clinical Documentation platform The mission of the platform is to Manage the TMFs of the sanofi pasteur Clinical Department Archive the TMF Manage Clinical edoc in collaboration with IS Platform TMF reps are members of the clinical department plaforms and designated liaisons between the their platform and Clinical Documentation. They provide support to their platform and CROs on the TMF process and tools. 10

11 TMF Management Process 1. Set-up the Trial TMF Contributors TMF Reps ClinDoc 2. Create / review / approve documents TMF Contributors 3. Submit documents to the TMF TMF Contributors 4. Process TMF documents ClinDoc 5. Monitor the TMF ClinDoc 6. Audit the TMF Auditor ClinDoc TMF Contributors 7. QC the TMF TMF Contributors ClinDoc 8. Archive the TMF ClinDoc 11

12 TMF Management Process 1. Set-up the Trial TMF Contributors TMF Reps ClinDoc ClinDoc Ensure that study-specifics are identified and taken into account in the TMF process Set-Up the study in Clinical edoc TMF Contributors Platform TMF Rep Ensure that all TMF contributors, including delegates such as CROs, are properly trained and have access to the TMF tools (GFL, clinical edoc, guidelines, etc..) 12

13 TMF Management Process 2. Create / review / approve documents TMF Contributors There are two types of TMF documents: Paper-native documents Documents with wet-ink signature and/or manually completed Mainly documents received from sites or Health authorities or Ethics committees. Upon collection, their content & readability have to be fully checked for TMF readiness by the TMF Contributors. Electronic-native documents These documents should be either created or imported in Clinical Doc They are then reviewed and/or approved according to the document category stated in the Global File List Paper-native documents still represent today approximately 40% of the TMF documents 13

14 TMF Management Process 3. Submit documents to the TMF TMF Contributors Documents should be submitted on an ongoing basis Documents need to be first checked for TMF readiness: Once the document is submitted to the TMF, it becomes a document that is inspectable/auditable, so one needs to ensure the document legibility, review its contents..etc..prior to submitting it to the TMF that the document is not a duplicate of a document already submitted to the TMF Some Documents have to be submitted as a package After the document has been checked for TMF readiness, it needs to be submitted to the TMF Paper-native documents: Documents have to be sent to Clinical Documentation together with a completed Transmittal Form Electronic-native documents: These documents are submitted to the TMF through Clinical edoc by launching a TMF workflow 14

15 TMF Management Process 4. Process TMF documents ClinDoc After documents have been submitted to the TMF, the Clinical documentation platform will process them Paper-native documents ClinDoc will check the documents received ClinDoc will then scan, import and index the documents in Clinical edoc and in the etmf Paper documents are then stored and filed in a secured storage room with restricted controlled access Electronic-native documents ClinDoc will review the documents and either accept the documents in the TMF (document TMF status changed to «Yes») or reject the documents (document TMF status changed to «reject». No paper version of these electronic-native document is kept 15

16 Paper-native Document Flow From Creation to Processing TMF Contributor ClinDoc Paper Document Collects, Checks document content, completes Transmittal Form and sends to ClinDoc Paper Document with Transmittal Form Checks Transmittal Form vs. document Scans, Import & TMF Yes Electronic Document in Clinical edoc with TMF status Yes Paper Document in Archive Room Document & Transmittal form sent back to sender 16

17 TMF Contributors ClinDoc TMF Rep TMF Contributors TMF Contributors ClinDoc ClinDoc TMF Contributors ClinDoc Electronic-native document flow From Creation to Processing 1. Set-up the Trial TMF 2. Create / review / approve documents 3. Submit documents to TMF TMF 4. Process TMF documents 5. Monitor the TMF 6. QC the TMF TMF Contributor Automatic task notification of rejected document ClinDoc Imported in Clinical edoc OR Created, reviewed and approved electronically in Clinical edoc Makes the modification Electronic document in Clinical edoc with TMF Status Rejected Finalized effective Document in Clinical edoc with TMF Status To Be Defined launches TMF workflow Not TMF document Document in Clinical edoc with TMF Status Pending Checks document properties vs. document content Rejects Document Accepts document in TMF and sets TMF Status to Yes Electronic document in Clinical edoc with TMF Status Yes Document in Clinical edoc with TMF Status N/A 17

18 TMF Management Process 5. Monitor the TMF ClinDoc On a regular basis, ClinDocs will review the TMFs and provide metrics on TMF completeness Volume of rejected documents Documents on-time submission to the TMF Documents processing turn-around time, etc.. Remediation plans are discussed between ClinDoc and TMF contributors and implemented in their respective areas. 6. Audit the TMF Auditor ClinDoc TMF Contributors Our Clinical Quality Assurance will audit the TMF as part of their audit plan During the audit Auditor will review the documents in the etmf area of clinical edoc through a specific view 18

19 TMF Management Process 7. QC the TMF TMF Contributors There are 2 types of QCs Contributors QC ClinDoc Objective: check TMF completeness and quality (full document content) ClinDoc QC Objective: check ClinDoc proper filing of TMF documents (whether paper or electronic-native documents) before archiving 8. Archive the TMF ClinDoc After the final TMF QC, The paper documents of the TMF are sent for long term archiving The electronic documents are e-archived (made invisible to users) Archived documents can be retrieved upon request to ClinDoc 19

20 Tour of Clinical edoc 20

21 Clinical edoc Launched in April 2009 Any new study starting after this date is an etmf trial The reference document in case of audit or inspection is the electronic document in the etmf For strategic projects, some retroactivity was decided: move paper trials into the etmf Sanofi-pasteur solution: Documentum (EMC) & D2 (C6) solution Standard EDMS within sanofi-pasteur Customized to meet etmf needs Interfaced with our CTMS, CRFsystems, and RA edoc users in 15 countries Open to CRO partners C6 Clinical edoc Red edoc IS edoc RA edoc, PV edoc..etc edoc v5 Core System D2 P2 C2 O2 E2 Documentum EMC IS 21

22 Clinical edoc in numbers Clinical edoc Users: there are 1040 users in Clinical edoc at the moment. 50% authors / 50% reviewers 27% of users are external users (CRO Partners, Temp.) Clinical edoc implementation: Clinical edoc is implemented in 17 countries world-wide the US/France and Region proportions are 1/3 each Regions 27% France 37% North America 36% Clinical edoc Documents: there are around documents in Clinical edoc. More than documents are created each month 22

23 Navigation Navigation tool Working views : display documents/information 23

24 The Working View Clinical Working View: Displays all the documents within the GFL hierarchy: Project/Trial/Folder/Sub-folder GFL 24

25 The TMF Views for contributors and ClinDoc TMF Views TMF Pending view Documents sent to a TMF workflow and awaiting processing by ClinDoc. TMF Reference view Documents sent to a TMF workflow and awaiting processing by ClinDoc. AND Documents processed and accepted by ClinDoc. TMF Reject view Documents sent through to a TMF workflow but rejected by ClinDoc and awaiting author corrections Each TMF view only displays TMF docs within a Project/Trial/Folder/Sub-folder hierarchy 25

26 The Inactivated trials Views for ClinDoc only Inactivated Clinical Projects/Trials (including archived) Accessible for ClinDoc only. Allows for e-archivig of documents Enhances performance (projects and trials not displayed to TMF contributors) 26

27 The TMF View for auditors/inspectors Inspector/Auditor consult documents within a TMF viewer Only documents that have a TMF status yes and pending Only on assigned trials (no access to project) TMF documents are displayed in specific views Hierarchies organized by document level = Core/Country/Site No access to the bottom screen tabs (workflow, audit trail, publishing..etc..) Only 3 activities possible View the document, only in pdf format with watermarks View the report review document (summarize the review/approval workflow performed on the selected document) Print 27

28 Documents Properties The GFL hierarchy Documents properties Are completed by document author for any new document creation. These properties can be inherited = speed up the properties completion Are critical to: search/ retrieve documents customize display views The TMF status : initial status defaulted according to the GFL: - To be defined by default if document type is a TMF document. - N/A by default if document type is not a TMF document. "Internal Only" box. If checked, it will hide the document from the CRO working views The document title. The title convention is displayed in the grey field Note: could be selected, copied and pasted. 28

29 The Trial ID card Objectives: pre-complete as many information as possible based on Trial information. E.g. language: when language are set in the ID card, the author will have limited choices instead of a list of hundreds of languages Decrease the number of properties that need to be completed on each document Increases quality of the edocument properties and thus proper filing 29

30 Implementation of an etmf at Sanofi-pasteur 30

31 etmf success factors Strong support from management Use of Clinical edoc (as EDMS and then etmf as well) was made mandatory for all functions all regions Integation of the etmf as a function of the EDMS tool Progressive approach: Sanofi-pasteur uses an EDMS in the clinical department since 2002 (Clinical edoc) was mainly used by medical writing function In preparation of the launch of an etmf, the usage of Clinical edoc became mandatory in all locations and all functions: In 2007 for all core documents created internally In 2008 for all submission documents (beginning of the scanning activity for externally created documents) In 2009 for all clinical documents In 2009, launch of the etmf which is an additional functionality of Clinical edoc Once a document is finalized or scanned in clinical edoc, a TMF workflow is launched Allowed the team to get used to the tool and experience the benefits Availability of documents anywhere anytime to anyone Overall few resistance at the start but quickly overcome by the experienced benefits At the launch of the etmf most of the compliance issues in using the EDMS were resolved 31

32 etmf success factors Ensure good performance of the system in all regions Challenge at sanofi-pasteur Being addressed through a dedicated taskforce. Still one of the main challenge of the application Clinical Documentation Organization dedicated to TMF management was already in place for 8 years The scope of responsibilities between the functions and the clinical documentation was not changed by the switch to etmf Processes well defined from start Process for paper documents: transmittal form, who should scan, etc Process for electronic documents: title conventions, properties to fill in.. Documents management & filing rules clearly defined in the Global File List (sanofipasteur TMF filing model) Address remaining cumbersome manual processes Scanning process In December 2011, sanofi-pasteur will implement an integrated tool for batch scanning, importing and completion of documents properties (automated from the transmittal form) Interface with CTMS for the transfer of monitoring reports (large volume of documents) Interface with CDMS for the transfer of CRFs 32

33 etmf success factors Constant communication on the process and the tool In 2010 we launched a TMF representatives Network (super users). Are the experts in each function on both the TMF processes and Clinical edoc Are closed to the field and better positioned to answer process or tool «how to?» questions to the end users. Are great resources for the tool or process evolutions Inspection readiness At etmf launch in 2009, the decision was to present a print out of the document to the inspector In Dec 2011, we will implemented the direct acces for inspectors to the etmf. We are also evaluating a tablet solution 33

34 etmf success factors Anticipate Evolution of the jobs in the Clinical Documentation function Administrative tasks are significantly reduced (less paper documents management and filing). As of today, 60% of TMF documents are directly created/imported in clinical edoc and added in the etmf by the Clinical Team Members 40% of TMF documents are in a paper format (e.g. collected at the investigator sites ) and are scanned /imported into the etmf. More TMF Management activities Education / Training / Motivation of clinical Teams Expertise on TMF processes and regulation to address increased trial complexity (mergers, co-development, etc..) Providing services and management reports to the team and propose corrective actions Management / Administration of the tool New business project leader job created Functional Administrators (level 2 support, tool administration) 34

35 Next Steps Clinical edoc 2.2 in Dec 2011 Batch Scanning Tool TMF Viewer for inspectors Trial ID Card Reporting Tool (metrics, list of documents, etc..) Other various enhancements on existing funcionalities (properties, notifications..) Clinicl edoc 2.3 in March Packages (being able to «group» documents) Withdraw a document Future Portal to exchange documents with investigators Define list of expected documents in order to issue «missing documents» reports. 35

36 Conclusion Great to build an etmf on a strong EDMS system. but an etmf is a system on its own and requires some significant customization to address specific needs: Not a repository but a living TMF documents management system: strong notifications capabilities with predefined recipients lists, etc Need to allow for the reconstruction of the full story of the trial: ability to group documents together, to customize display views by date, by type, etc.. Inspection readiness: inspectors want a user friendly system: no more than 30 min training, ability to attach «sticky notes on documents they have questions on, performant system, etc.. Ability to define the expected documents per trial at trial start. This will allow for a close monitoring of TMF completeness on an ongoing basis and help with compliance. Portal functionality to exchange documents with investigators and health authorities/ Ethics comittees (will significantly decrease paper documents management) Strong reporting needs Strong performance needs: clinical trial teams are generaly spread accross the world. Also the pharma industry is outsourcing a lot to CROs (thus external companies with their own network, etc..) but TMF is kept internally. 36

37 Conclusion Another definition of the TMF: Too Much Fun! 37

38 Thank you for your attention Any questions? 38

39 Thank you 39