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

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Presentation on theme: "Using web service technologies for incremental, real- time data transfers from EDC to SAS Andrew Newbigging Vice President, Integrations Development 19."— Presentation transcript:

1 Using web service technologies for incremental, real- time data transfers from EDC to SAS Andrew Newbigging Vice President, Integrations Development 19 th 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 Introduction General Considerations Web Services Conclusion Agenda

3 © 2010 Medidata Solutions Worldwide 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? 3 EDCSAS

4 Introduction General Considerations Web Services Conclusion Agenda

5 © 2010 Medidata Solutions Worldwide Cumulative data volumes in a clinical study 5

6 © 2010 Medidata Solutions Worldwide Average daily change 6

7 © 2010 Medidata Solutions Worldwide Cuumulative vs. incremental 7 CumulativeIncremental Repeated re-transfer of unchanged data: inefficient and time-consuming Only data changes transferred: maximum efficiency Difficult to achieve real-time data transfer Near real-time transfer possible Entire data set always sent – no data lost if one transfer fails How to recover from a transfer error: checksum/resend protocol required

8 © 2010 Medidata Solutions Worldwide 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 8

9 © 2010 Medidata Solutions Worldwide Data transfer formats and standards 9 TextSASCDISC SDTM CDISC ODM All studiesYYNY Human readable YNYY MetadataN(Y)NY Incremental / cumulative (Y)NNY Open standard NNYY

10 © 2010 Medidata Solutions Worldwide CDISC ODM – Clinical data structure 10

11 © 2010 Medidata Solutions Worldwide CDISC ODM - Example 11

12 Introduction General Considerations Web Services Conclusion Agenda

13 © 2010 Medidata Solutions Worldwide 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 13

14 © 2010 Medidata Solutions Worldwide 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 14

15 © 2010 Medidata Solutions Worldwide REST in the browser

16 © 2010 Medidata Solutions Worldwide REST in the browser

17 © 2010 Medidata Solutions Worldwide REST in the browser

18 © 2010 Medidata Solutions Worldwide 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 connected * Connected to innovate.mdsol.com ( ) 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: :49:39 GMT * expire date: :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= * SSL certificate verify ok. 18

19 © 2010 Medidata Solutions Worldwide 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/ (universal-apple-darwin10.0) libcurl/ OpenSSL/0.9.8l zlib/1.2.3 > Host: innovate.mdsol.com > Accept: */* > Content-Type:text/xml > < HTTP/ OK < Date: Tue, 14 Sep :18:05 GMT < Content-Type: text/xml < … 19

20 © 2010 Medidata Solutions Worldwide Incremental requests https://innovate.mdsol.com/RaveWebServices/ https://innovate.mdsol.com/RaveWebServices/ studies/Mediflex/datasets/regular/AE? start= T15:00:00 ODM TransactionType: Insert Update Remove 20

21 © 2010 Medidata Solutions Worldwide REST and SAS Clinical Data Integration(CDI) 21

22 © 2010 Medidata Solutions Worldwide 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/ 22

23 © 2010 Medidata Solutions Worldwide 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 23

24 Introduction General Considerations Web Services Conclusion Agenda


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