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
Introduction
General Considerations
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
Introduction
General Considerations
Web Services
Conclusion

5. Cumulative data volumes in a clinical study

6. Average daily change

7. Cuumulative vs. incremental
Cumulative
Incremental
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. 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
Text
SAS
CDISC SDTM
CDISC ODM
All studies Y N
Human readable
Metadata
(Y)
Incremental / cumulative
Open standard

10. CDISC ODM – Clinical data structure

11. CDISC ODM - Example

12. Agenda
Introduction
General Considerations
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)
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
* 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):
* 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= CN=Go Daddy Secure Certification Authority; serialNumber=
* 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/ (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
<
<?xml version="1.0" encoding="utf-8"?>
<ODM
FileType="Snapshot"
FileOID=" f aad3-e9f12459ca20"
CreationDateTime=" T01:18: :00"
ODMVersion="1.3"
xmlns:mdsol="
xmlns:xlink="
xmlns=" …

20. Incremental requests
studies/Mediflex/datasets/regular/AE? start= T15:00:00
ODM TransactionType:
Insert
Update
Remove

21. REST and SAS Clinical Data Integration(CDI)

22. REST and SAS CDI GET list of studies
GET study metadata
/studies/Mediflex/metadata/
GET clinical data
/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 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
Introduction
General Considerations
Web Services
Conclusion