1 Using web service technologies for incremental, real-time data transfers from EDC to SAS Andrew NewbiggingVice President, Integrations Development19th October 2010Medidata Solutions, Inc. Proprietary - Medidata and Authorized Clients Only.This document contains proprietary information that shall be distributed, routed or made available only within Medidata, except with written permission of Medidata.
3 IntroductionData transfers from EDC to SAS are typically cumulative (all data) transferred in batch mode (infrequently) in files formatted in a SAS proprietary format:How can we utilize modern technologies and standards to improve efficiency, reliability and information density?EDCSAS
7 Cuumulative vs. incremental CumulativeIncrementalRepeated re-transfer of unchanged data: inefficient and time-consumingOnly data changes transferred: maximum efficiencyDifficult to achieve real-time data transferNear real-time transfer possibleEntire data set always sent – no data lost if one transfer failsHow to recover from a transfer error: checksum/resend protocol required-+-+-+
8 Data transfer formats Desirable features: Support any clinical study design and dataHuman-readableSelf-describing (metadata)Support for incremental or cumulative transfersOpen, not proprietary, format
9 Data transfer formats and standards TextSASCDISC SDTMCDISC ODMAll studiesYNHuman readableMetadata(Y)Incremental / cumulativeOpen standard
13 Web servicesWeb services are application programming interfaces (API) that are accessed via the Hypertext Transfer Protocol (HTTP)Simple Object Access Protocol (SOAP) is one styleRepresentational State Transfer (REST) is our preferred approach
14 REST REST uses HTTP methods or verbs: GETPUTPOSTDELETETo access objects via Uniform Resource Identifiers (URI)https://innovate.mdsol.com/RaveWebServices/studies/Mediflex/datasets/regular/AEReturning HTTP status codes:200 OK401 Unauthorized404 Not Found
22 REST and SAS CDI GET list of studies GET study metadatahttps://innovate.mdsol.com/RaveWebServices/ /studies/Mediflex/metadata/GET clinical datahttps://innovate.mdsol.com/RaveWebServices/ /studies/Mediflex/datasets/
23 Challenges Consistency Metadata versions Incremental transfers are more efficient, but how can the overall integrity of transferred data be assessed?Hash functions (md5, sha1, etc) being investigatedMetadata versionsTo accommodate changes during a study (for example a protocol amendment) CDISC ODM may have multiple metadata versionsThere are no constraints on changes between versionsExtra care needed to ensure that the correct metadata version is applied to each data point
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