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Using web service technologies for incremental, real-time data transfers from EDC to SAS

Learn how to leverage modern web service technologies for efficient and reliable real-time data transfers from EDC to SAS. Explore the use of CDISC ODM, REST API, and more. This document contains proprietary information.

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Using web service technologies for incremental, real-time data transfers from EDC to SAS

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  1. Using web service technologies for incremental, real-time data transfers from EDC to SAS Andrew Newbigging Vice President, Integrations Development 19th October 2010 Medidata 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.

  2. Agenda General Considerations Introduction Web Services Conclusion

  3. Introduction • Data 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? EDC SAS

  4. Agenda General Considerations Introduction Web Services Conclusion

  5. Cumulative data volumes in a clinical study

  6. Average daily change

  7. Cuumulative vs. incremental - + - + - +

  8. Data transfer formats Desirable features: • Support any clinical study design and data • Human-readable • Self-describing (metadata) • Support for incremental or cumulative transfers • Open, not proprietary, format

  9. Data transfer formats and standards

  10. CDISC ODM – Clinical data structure

  11. CDISC ODM - Example

  12. Agenda General Considerations Introduction Web Services Conclusion

  13. Web services • Web services are application programming interfaces (API) that are accessed via the Hypertext Transfer Protocol (HTTP) • Simple Object Access Protocol (SOAP) is one style • Representational State Transfer (REST) is our preferred approach

  14. REST • REST uses HTTP methods or verbs: • GET • PUT • POST • DELETE • To access objects via Uniform Resource Identifiers (URI) • https://innovate.mdsol.com/RaveWebServices/studies/Mediflex/datasets/regular/AE • Returning HTTP status codes: • 200 OK • 401 Unauthorized • 404 Not Found

  15. REST in the browser - 1

  16. REST in the browser - 2

  17. REST in the browser - 3

  18. REST from the command line - 1 • curl -u username:password -H 'Content-Type:text/xml' -v https://innovate.mdsol.com/RaveWebServices/studies/Mediflex/datasets/regular/AE • * About to connect() to innovate.mdsol.com port 443 (#0) • * Trying 70.42.99.224... connected • * Connected to innovate.mdsol.com (70.42.99.224) port 443 (#0) • * SSLv3, TLS handshake, Client hello (1): • * SSLv3, TLS handshake, Server hello (2): • * SSLv3, TLS handshake, CERT (11): • * SSLv3, TLS handshake, Server finished (14): • * SSLv3, TLS handshake, Client key exchange (16): • * SSLv3, TLS change cipher, Client hello (1): • * SSLv3, TLS handshake, Finished (20): • * SSLv3, TLS change cipher, Client hello (1): • * SSLv3, TLS handshake, Finished (20): • * SSL connection using RC4-MD5 • * Server certificate: • * subject: O=*.mdsol.com; OU=Domain Control Validated; CN=*.mdsol.com • * start date: 2007-03-28 17:49:39 GMT • * expire date: 2017-04-03 14:34:46 GMT • * subjectAltName: innovate.mdsol.com matched • * issuer: C=US; ST=Arizona; L=Scottsdale; O=GoDaddy.com, Inc.; OU=http://certificates.godaddy.com/repository; CN=Go Daddy Secure Certification Authority; serialNumber=07969287 • * SSL certificate verify ok.

  19. REST from the command line - 2 • * Server auth using Basic with user 'username' • > GET /RaveWebServices/studies/Mediflex/datasets/regular/AE HTTP/1.1 • > Authorization: Basic ******************************** • > User-Agent: curl/7.19.7 (universal-apple-darwin10.0) libcurl/7.19.7 OpenSSL/0.9.8l zlib/1.2.3 • > Host: innovate.mdsol.com • > Accept: */* • > Content-Type:text/xml • > • < HTTP/1.1 200 OK • < Date: Tue, 14 Sep 2010 01:18:05 GMT • < Content-Type: text/xml • < • <?xml version="1.0" encoding="utf-8"?> • <ODM • FileType="Snapshot" • FileOID="96741552-97f4-4035-aad3-e9f12459ca20" • CreationDateTime="2010-09-14T01:18:05.255-00:00" • ODMVersion="1.3" • xmlns:mdsol="http://www.mdsol.com/ns/odm/metadata" • xmlns:xlink="http://www.w3.org/1999/xlink" • xmlns="http://www.cdisc.org/ns/odm/v1.3" • > • … • … • …

  20. Incremental requests https://innovate.mdsol.com/RaveWebServices/ studies/Mediflex/datasets/regular/AE? start=2010-09-01T15:00:00 ODM TransactionType: Insert Update Remove

  21. REST and SAS Clinical Data Integration(CDI)

  22. REST and SAS CDI • GET list of studies https://innovate.mdsol.com/RaveWebServices/ studies/ • GET study metadata https://innovate.mdsol.com/RaveWebServices/ /studies/Mediflex/metadata/ • GET clinical data https://innovate.mdsol.com/RaveWebServices/ /studies/Mediflex/datasets/

  23. Challenges • Consistency • Incremental transfers are more efficient, but how can the overall integrity of transferred data be assessed? • Hash functions (md5, sha1, etc) being investigated • Metadata versions • To accommodate changes during a study (for example a protocol amendment) CDISC ODM may have multiple metadata versions • There are no constraints on changes between versions • Extra care needed to ensure that the correct metadata version is applied to each data point

  24. Agenda General Considerations Introduction Web Services Conclusion

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