Maintaining a Validated SAS Toolset Co-Presenters Edward Helton

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CDA & CDISC in Starbrite Trial Merged workflow: clinical trial data captured in initial CDA, re-used in chart note HIS lab, ADT, meds, source documents LIS validation CDA(1) ODM e. CRF db Proposed processes (single source) display CDA(2) complete chart note CLINIC Copyright © 2005, SAS Institute Inc. All rights reserved. CRO Source: Liora Alschuler, Landen Bain, Rebecca Kush, Ph. D. 2

Agenda § Part 11 and the Predicate Rules § Applying the Predicate Rules to Maintenance of a Validated SAS Toolset § Support from SAS (now and future) Copyright © 2005, SAS Institute Inc. All rights reserved. 4

Update on Part 11 GMP by the Sea August 25, 2004 Rick Friedman, Team Leader Guidance & Policy Division of Manufacturing and Product Quality Office of Compliance, CDER 6

FDA Regulation References - GCP § Strong New FDA Industry Guidances in GCPs § 50. 20 – 312. 56 ( c) – sponsors shall review and evaluate evidence related to safety and effectiveness § 312. 57 (a) – Records must be Accurate & Complete § 312. 62(a, b, c) – Investigator Recordkeeping - drug disposition, case histories, record retention Copyright © 2005, SAS Institute Inc. All rights reserved. 7

FDA Regulation References - GMP § 211. 22 (a) – Quality control unit has the authority to approve and reject § 211. 67 ( c) – Records shall be kept of maintenance, cleaning, sanitizing, and inspection § 211. 68 – Validation requirements of automated equipment § 211. 100 (a) - Written procedures for production and process control § 211. 180 (a), (b), and ( c) – Retention period for records Copyright © 2005, SAS Institute Inc. All rights reserved. 8

FDA Regulation References - GLP § 58. 29 (b) – must maintain current summary of training for those engaged, or supervising the conduct of a non-clinical study § 58. 33 (b) – all experimental data… must be accurately recorded § 58. 35 (b) (4) – periodically submit a written status report noting problems and corrections § 58. 63 ( c) – records maintained of all inspections, maintenance records, testing, calibration and/or standardizing operations Copyright © 2005, SAS Institute Inc. All rights reserved. 9

FDA Regulation References Devices § 21 CFR 812. 145 (a) & (b) - Records must be Accurate & Complete § 21 CFR 812. 140 – must retain records required by 812 Copyright © 2005, SAS Institute Inc. All rights reserved. 10

21 CFR Part 11 - Upcoming Amendment § Comments collected on the existing rule § Support for Part 11 in general § It is not going away – expect rewrite in future Copyright © 2005, SAS Institute Inc. All rights reserved. 12

Standard Data / JANUS § Tools to receive, upload analyze data § Unambiguous path of the source data to the analysis findings (metadata, derivations, flags, imputations, source code, analysis files) § Focus on standard data and standard analysis makes maintaining validation even more critical – valid interface, interaction between SAS systems § This makes your SAS configuration even more important! Copyright © 2005, SAS Institute Inc. All rights reserved. 13

Standard Data / JANUS § Right now it takes analysis of many applications to find common trends. § One study took 10 person years. § We don’t have that kind of time to “find” the right data. § Standardization enhances the need for a validated SAS system. Copyright © 2005, SAS Institute Inc. All rights reserved. 16

Customer Validation of SAS 9 -Applications AERS Validat ed System Interim Analysis Integrated Safety Report Customer Validation of SAS 9 -- Toolset SAS Validation of SAS 9 Copyright © 2005, SAS Institute Inc. All rights reserved. 17

Identify and Describe Changes § Sources of Information • • Tech Support SAS Notes Mail & File Lists (TSNEWS-L) Monitoring Tools § Sources of SAS Updates • Hot Fixes • Service Packs Copyright © 2005, SAS Institute Inc. All rights reserved. 22

SASIQ/SASOQ § § Automated Tested Repeatable Reports and Stores Results (XML) http: //support. sas. com/rnd/migration/planning/valid ation/ Copyright © 2005, SAS Institute Inc. All rights reserved. 2003, 27

End-to-End Seamless Integration; Semantic Interoperability Open Data Model - XML based, CDISC compliant Investigator ODM CDMS Op DB LAB Subject Patients SDTM ADa. M Approval Pharma Physician Medical & Statistical Reviewers Source: Dave Iberson-Hurst 36