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Retrieving Medical Records Within FDA’s Sentinel Distributed Network: Lessons Learned During a Protocol-Based Assessment Involving 13 Data Partners

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    This publication describes lessons learned during a protocol-based assessment of thromboembolic events (TEE) following intravenous immunoglobulin (IGIV) administration, a project that necessitated chart retrieval requests for a large number of patients from 13 Sentinel Data Partners.

    Author(s)

    Crystal Garcia MPH, Candace Fuller PhD, Madelyn Pimentel BA, Eric Ammann MS, Elizabeth Chrischilles PhD, MS, Scott Winiecki MD