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insights LIFESCIENCELEADER.COM JULY 2014 44 CLINICAL TRIALS Methods Used To Exchange TMF Documents Between Sponsors And CRO Multiple Names For Same Document Figure1 Figure2 Email Paper Shipments (FedEx, UPS) Portal Cloud File Share (FTP, Box) CMS (SharePoint, Documentum) Fax eTMF application (Veeva, NextDocs) Specif cation Signoff Computer System Validation Packet Trial Master File Plan Requirement Summary Report Validation Report Validation Package Validation Documentation Release Documentation Records Management Plan File Plan Filing Instructions Common Name Various Names 68% 25% 43% 57% 15% 29% 29% *Source: Veeva Systems, The Paperless TMF, An Industry Benchmark 2014 – (Percent of respondents, n=260) est challenge in managing a TMF is the lack of visibility into the status of clinical trial documentation. eTMF reports such as study site document status, site acknowl- edgement of investigator brochure, and document expiry can all help inspection readiness by providing greater visibility this, establishing a repeatable framework is an important part of the change man- agement process. Defining each stake- holder's role is also critical to successful outsourcing, finds an Avoca Group survey of 237 respondents. Collaborative relation- ships "require absolute clarity in roles and responsibilities and up-front plan- ning assumptions," Avoca states. Typical clinical collaborations have lacked this clarity, sometimes resulting in difficulties and disappointment in the relationship. "The biggest issue when it comes to tran- sitioning to a new type of system – from paper to electronic, for example – is the fear of losing control. But, when employ- ees and partners see the increase in effi- ciency that comes from a more stream- lined, repeatable process, then they are more likely to embrace the system and accept a new 'digital' mindset," said Fate. Additional elements of the repeatable framework include operationalizing SOPs by configuring them within the eTMF application, essentially codifying them into system workflows. The eTMF application orchestrates task completion across com- panies and stakeholders, in keeping with company SOPs. A common workflow auto- mates many manual steps, improving pro- ductivity and trial efficiency. By compari- son, a paper-based TMF or eArchive relies on people remembering and following writ- ten SOPs and then documenting them. When collaborative processes are cou- pled with a repeatable framework, the foundation is in place to begin defining and leveraging performance metrics. DEFINING AND TRACKING PERFORMANCE METRICS The eTMF can track operational metrics for a specific study by which documents have been completed or remain unfin- ished and which need follow-up. These simple daily metrics are a good place to start, according to Linda Sullivan, COO of Metrics Champion Consortium, an asso- ciation dedicated to standardized perfor- mance metrics. A 2014 survey by NextDocs supports the notion that operational metrics are important but remain a challenge. In fact, the survey indicates that the second larg- have full visibility and can track the status of the TMF in real time for the duration of the study so we can identify bottle- necks or missing documents along the way. We don't have to wait until the end when 'surprises' can force us to backtrack, which wastes so much time. We can now manage workflow much better and close studies sooner, which will translate into cost savings." BUILDING A REPEATABLE FRAMEWORK Building a repeatable TMF framework involves defining expectations upfront to ensure all TMF participants are aligned and in agreement on what the TMF arti- facts are called, when they are due, and who is responsible for filing them. In order to know what content is missing or late, all contributors must first understand what is expected. A repeatable framework sets expectations at the outset, reinforces the collaborative process, and improves overall efficiency. Standardizing a common nomenclature drives better communication by harmo- nizing the filing efforts of diverse stake- holders. When multiple parties refer to items by different names (Figure 2), filing and tracking become confusing, increas- ing the chance for error. The nomencla- ture defined by the Drug Information Association's (DIA's) TMF Reference Model represents input from hundreds of phar- maceutical companies, CROs, regulatory agencies, and vendors from across the globe. In addition to standardized naming, the TMF Reference Model introduces stan- dards for content, structure, and metada- ta. For these reasons, more and more clin- ical trial sponsors, including Kythera, are leveraging this model to build their own repeatable framework. When setting the framework, it is essen- tial to establish time frames for complet- ing management milestones, as well as roles and responsibilities for execution. In many cases, the responsibility for fil- ing TMF documents and other content will shift from a records management function to the author/owner in the TMF. Managing a successful process change is critical for gaining many of the benefits associated with using an eTMF. Because of By J. Goldsmith, L. Mulcahy ETMFS: MOVING FROM ELECTRONIC FILING CABINET TO STRATEGIC ASSET 0 7 1 4 _ C l i n i c a l T r i a l . i n d d 3 0714_ClinicalTrial.indd 3 6 / 2 0 / 2 0 1 4 1 2 : 3 0 : 1 8 P M 6/20/2014 12:30:18 PM