Key Stakeholders
To begin the EDC integration process, relevant stakeholder participation during the kick-off and throughout the implementation is critical to success. While the EDC technical and clinical teams should lead the discussions, PV safety/operational staff should be included, along with the technical and PV safety database IT staff, to ensure compatibility with the safety database and to regulatory requirements. If possible, it is best to include all relevant stakeholders prior to the EDC design and build.
Throughout the implementation discussions, issues must be identified and addressed at the time of initial set up to prevent extensible markup language (XML) import failures, which lead to increased manual data entry efforts and potential for increased costs to the trial sponsor.
EDC to Safety Database Mapping Issues
Next, mapping of critical EDC and safety database fields must be completed with knowledgeable PV and project SMEs, along with E2B safety database experts. This process, along with the consideration of all mandatory E2B fields and optional default values, will ensure correct mapping prior to testing, and implementation. Additional key information that should be shared across relevant stakeholders includes associated E2B workflow and mapping documentation, as well as EDC limitations, deviations, and non-compliance factors.
Integration Testing
While it is acceptable to test integration with perfect EDC entry, real-life data should also be utilized to test the integration of systems. Why? Often, site personnel will enter incomplete information into the EDC, thus leading to inaccurate data upon entry into the safety database. Testing real-life data allows the safety team to try to anticipate data entry errors and incomplete field entry to fully stress test the system integration.
Remediation, Action Plan and Next Steps
Finally, as the mapping issues and/or results of testing become evident, the team needs to consider potential solutions and document remedial actions for ideal set up to ensure EDC fields are XML-compliant. Emphasis should be placed on the sensitivity of EDC triggers for follow-up XML reports to the safety database to confirm XMLs are generated and transmitted only when new safety information has been received.
Even after the gateway has been set up, the PV team should carefully review and interpret transmitted data on an ongoing basis. Site training on correct EDC data entry and functionality will be instrumental, as data entry errors at the site may prevent XMLs from being transmitted and successfully accepted into the safety database, which could lead to increased site safety queries or increased manual entry by the safety team.
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ABOUT UBC:
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Our combined scientific expertise in pharmacovigilance, risk management, and signal detection and assessment, underpinned by innovative technologies, offer our customers flexible solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.
ABOUT THE AUTHORS:
Michel Rempel, PharmD, Senior Director of PV Client Services
Dr. Rempel has 14 years of PV experience and serves as a member of our global PV Leadership Team. She is responsible for leading business development activities from client proposal and budget preparation through PV project operationalization. In addition, Dr. Rempel oversees PV client governance meetings and manages PV marketing strategy and development. Dr. Rempel has worked in PV since 2010, participating in, and leading, all aspects of clinical trial, post-marketing, and medical device safety including case processing activities, literature screening and review, aggregate report preparation and development, and signal detection activities.
Erin Williamson, Team Manager, PV Global Case Processing
Ms. Williamson has almost 20 years of PV experience. She is responsible for the oversight and execution of global Pharmacovigilance (PV) case processing activities contracted by UBC’s clients. This includes responsibility for and oversight of deliverables which ensure regulatory compliance, data quality, and team productivity. Outside of UBC, she has has industry experience in clinical and drug safety at ICON, Wyeth, and Pfizer. She has a broad PV experience for a wide range of drugs, biologics and devices, both in clinical development and post-marketing, including case processing and submission activities, signal management activities and aggregate safety reports.
