Developing an Integrated Platform

Transcription

1 Developing an Integrated Platform Jean-Marc Ferran Consultant & Owner Mobile Qualiance ApS Guldbergsgade 25, st th 2200 Copenhagen N Bart Van Win & Sebastien Roland Developers Tel Fax Mobile bart.vanwin@businessdecision.com sebastien.roland@businessdecision.com Contract Research Organisation Business & Decision Life Sciences Sint-Lambertusstraat 141 Rue Saint-Lambert 1200 Brussels Getting the best out of several technologies

2 Technical Platform - high level flow DATA COLLECTION AREA DBA DH10: Time Travel for Librarians: Versioning Complex Library Metadata for Past, Present or Future Retrieval SD04: An Integrated Platform for Standards Management and Study Conduct DATA MANAGEMENT AREA TS06: Developing an Integrated Platform, Getting the Best out of Several Technologies DATA STANDARDS SPECIFICATION DM REPOSITORY CD14: Is your Library a Success: Manage and Measure Conformance Across Partners and Projects VALIDATION EDC ISSUE REPORTS SPECIFICATION COMPARISON ISSUE REPORTS CRO SD05: Data Validation, Getting Full Control over your Data Standards Compliance and Data Flow CC06: Dynamic Programming with XMLTemplates SDTM DATA & DEFINE.XML

3 Implementation Architecture and solution overview Main processes Data standards library overview Study metadata build process Study validation process Integration features Single user access model implementation Reporting capability and project-level access Audit trailing Library and Study Metadata validation flow

4 Architecture and solution overview USER INTERFACE EXTENDED APPLICATIONS APPLICATION LAYER MANAGEMENT SPECIFCATION and REPOSITORY SERVICE LAYER LOG IN VALIDATION and ISSUE TRACKING API CREATE JOB RUN JOB UPLOAD DOWNLOAD MOVE OBJECTS JAVA READ SEND OBJECT NOTIFICATIONS ATTRIBUTES CREATE FOLDER STRUCTURE & PERMISSIONS USER INTERFACE USER INFORMATION PROGRAMS FILES MAKE OBSOLETE EDIT COPY QUERY VALIDATE ACCESS WORKSPACE DATA STANDARD REPOSITORY AUDIT LOG DEFINE.XML DOCUMENTS DATASETS OUTPUTS OBJECT REPORT ORACLE DATABASE DATABASE DRUG DEVELOPMENT 4.2 DATA CREATE ISSUE TRACKING AUDIT TRAIL

5 Data Standards Library The Data Standards Library DATA COLLECTION contains : MODULES Data Collection Modules: using CDASH metadata with clustered SDTM metadata SDTM 1.3 annotated for CDASH SDTM IG annotated for SDTM Metadata Definitions : SDTM Standards Therapeutic Area Standards THERAPEUTIC AREA DATA STANDARDS

6 Data Collection Modules - CDASH DATA COLLECTION MODULES DM 1 DM 2 VS 1 VS 2 EG 1... CRF template using CDASH annotations

7 Data Collection Modules - SDTM DATA COLLECTION MODULES DM 1 DM 2 VS 1 VS 2 EG 1...

8 Metadata Definitions DATA STANDARDS DATA COLLECTION MODULES 5 levels of metadata SDTM IG and TA metadata stored in the same physical tables SDTM 1.3 SDTM IG DEFINITIONS THERAPEUTIC AREA DOMAIN COMPUTATIONAL ALGORITHMS VARIABLE CONTROLLED TERMINOLOGY VALUE LEVEL

9 Study Metadata Build Process (Overview) DATA STANDARDS DATA COLLECTION MODULES SPECIFICATION MODULE SDTM 1.3 SDTM IG V1 V2 DM001 THERAPEUTIC AREA VS003 VS002 EX001 IE005 EG005 EG004 REPOSITORY TEMPORARY BUILD REPOSITORY BUILD PARAMETERS VISIT SCHEDULE PARAMETERS VISIT SCHEDULE TRIAL DESIGN DATA TRIAL DESIGN DATA VALIDATE API API DEFINE.XML COMPARISON WITH PREVIOUS BUILD

10 Study Validation Process (Overview) CREATE AND RUN CHECKS API ENVIRONMENT PROGRAMS DATA FILES JOB OF CHECKS REPOSITORY COMPARE AGAINST COMPARE DEFINE.XML DATASETS DOCUMENTS OUTPUTS EXCEPTION REPORTS DATA STANDARDS GLOBAL AND THERAPEUTIC EXCEPTION TABLES

11 CREATE AND RUN CHECKS Study validation / job of checks API CREATE AND RUN CHECKS ENVIRONMENT PROGRAMS JOB OF CHECKS DATA DEFINE.XML DATASETS FILES DOCUMENTS OUTPUTS EXCEPTION REPORTS ENVIRONMENT PROGRAMS JOB OF CHECKS REPOSITORY COMPARE AGAINST COMPARE DATA DEFINE.XML DATASETS FILES DOCUMENTS OUTPUTS EXCEPTION REPORTS DATA STANDARDS GLOBAL AND THERAPEUTIC EXCEPTION TABLES

12 Integration features USER INTERFACE EXTENDED APPLICATIONS APPLICATION LAYER MANAGEMENT SPECIFCATION and REPOSITORY SERVICE LAYER LOG IN VALIDATION and ISSUE TRACKING API CREATE JOB RUN JOB UPLOAD DOWNLOAD MOVE OBJECTS JAVA READ SEND OBJECT NOTIFICATIONS ATTRIBUTES CREATE FOLDER STRUCTURE & PERMISSIONS USER INTERFACE USER INFORMATION PROGRAMS FILES MAKE OBSOLETE EDIT COPY QUERY VALIDATE ACCESS WORKSPACE DATA STANDARD REPOSITORY AUDIT LOG DEFINE.XML DOCUMENTS DATASETS OUTPUTS OBJECT REPORT ORACLE DATABASE DATABASE DRUG DEVELOPMENT 4.2 DATA CREATE ISSUE TRACKING AUDIT TRAIL

13 Integration features (1) User access and security model APPLICATION LAYER Roles Projects accesses 1b - Open simultaneously session in new tab Studies accesses API SERVICE LAYER LOG IN API CREATE JOB RUN JOB UPLOAD DOWNLOAD MOVE OBJECTS READ SEND OBJECT NOTIFICATIONS ATTRIBUTES 1a - Log in to Recover user roles, groups and accesses USER INTERFACE DATABASE DRUG DEVELOPMENT 4.2 USER INFORMATION PROGRAMS DATA FILES 2 Return log in sucess/failure and user s roles, groups and accesses CREATE FOLDER STRUCTURE & PERMISSIONS AUDIT LOG DEFINE.XML DOCUMENTS DATASETS OUTPUTS OBJECT Accesses to modules, functionalities, projects and studies according to roles, groups and accesses 1 access model and log-in

14 Integration features (2) Reporting capability and access to Oracle ORACLE DATABASE ENVIRONMENT PROGRAMS DATA DATA STANDARD DEFINE.XML FILES DOCUMENTS ISSUE TRACKING DATASETS REPOSITORY AUDIT TRAIL OUTPUTS Data Standards Library Comparison Study metadata comparison across study versions Implementation Guides Study metadata comparison across projects Completion Guides Define.xml Trial summary-based search reports Export of trial design datasets Metrics reports Study metadata-based search reports

15 Integration features (2) Project/study-level access to Oracle tables USER INTERFACE Virtual Private Database Policies DRUG DEVELOPMENT 4.2 Project 1 User_project_1 -> where project_nb = project 1 PROGRAMS Project 2 DATA DEFINE.XML User_project_2 -> where project_nb = project 2 DATASETS Project 3 User_project_3 -> where project_nb = project 3 FILES DOCUMENTS OUTPUTS Virtual Private Database Policies attached to each study metadata table Access to study metadata can be restricted by projects at row level access using virtual private databases Dynamic where clausing automatically applied according to Oracle user id Ex: Where project_nb=project 1 Ref:

16 Integration features (2) Use of encoded passwords in Oracle password is encrypted in using proc pwencode Programs creating the libnames are stored in designated area with restriced access Ref: Keep your database passwords out of the clear: Quick and easy tips to protect yourself, Steven, PNWSUG 2007

17 Integration features (3) Audit trail DATABASE USER INFORMATION USER INTERFACE DRUG DEVELOPMENT 4.2 AUDIT LOG lar regu a d o n SD D e t c m a Extr asis fro ase b b data PROGRAMS DATA FILES DEFINE.XML DOCUMENTS DATASETS OBJECT ORACLE DATABASE Re ad OUTPUTS fro m SD D AUDIT TRAIL REPOSITORY DATA STANDARD ISSUE TRACKING Audit trails in same structure is easily integrated for reporting

18 Integration features (3) Audit trail structure 2 tables Main table 1 row per action Log-in, log-out Edit/Create/Validate metadata Make obsolete Etc. Detailed table Linked to main table per action id 1 set of rows per action 1 row for every change listing old and new values

19 Integration features (4) Library/Study Metadata validation flow (1) USER INTERFACE BDLS APPLICATIONS 1- User select metadata to validate 4 Feedback is returned to UI SERVICE LAYER API CREATE JOB LOG IN RUN JOB UPLOAD DOWNLOAD MOVE OBJECTS READ SEND OBJECT NOTIFICATIONS ATTRIBUTES CREATE FOLDER STRUCTURE & PERMISSIONS USER INTERFACE DRUG DEVELOPMENT 4.2 ORACLE DATABASE DATA STANDARD 2 Job of consistency checks programs is created PROGRAMS accordingly and run in DATA DEFINE.XML 3a Consistency report is created FILES DOCUMENTS 3b Oracle table is updated DATASETS OUTPUTS ISSUE TRACKING REPOSITORY AUDIT TRAIL SQL > Grant update(validation_flag) SQL> Grant select, insert, update(issue_status)

20 Integration features (4) Library/Study Metadata validation flow (2) Integrity checks Java based Ensure database integrity Updates require new minor release under Computer Validation procedures Metadata consistency and study checks based Stored in environment Ensure compliance with CDISC rules Controled via look-up tables Can be updated/enhanced following Use-of-theSystem procedures

21 Conclusion (1) No redundance in information Java,, Oracle provide each great benefits User information, privileges and project/study accesses located and managed in one place No duplication of metadata, continous access to metadata repository in Oracle Java technologies: User friendly web interfaces Services for integration Analytical power Well-known by users Code can be updated outside new release Row-level access and locking Further security features Use of virtual private database policies : Oracle:

22 Conclusion (2) Next steps Improving feedback on jobs status within web-applications UI Optimize use of virtual private database policy concepts

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