Program Life-Cycle Management in LSAF PHUSE SDE Utrecht 2019 10. - - PowerPoint PPT Presentation

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Program Life-Cycle Management in LSAF PHUSE SDE Utrecht 2019 10. - - PowerPoint PPT Presentation

Sep 07, 2022 177 likes •556 views

d n Program Life-Cycle Management in LSAF PHUSE SDE Utrecht 2019 10. October 2019, Nutricia Research Bjarke Mirner Klein, Director of Statistical Operations (Ferring Pharmaceuticals) Jean-Marc Ferran, Principal Consultant (Qualiance) d n

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Program Life-Cycle Management in LSAF

PHUSE SDE Utrecht 2019

  • 10. October 2019, Nutricia Research

Bjarke Mirner Klein, Director of Statistical Operations (Ferring Pharmaceuticals) Jean-Marc Ferran, Principal Consultant (Qualiance)

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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation Plans at Ferring
  • Tackling Dependencies in LSAF
  • Conclusion
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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation Plans at Ferring
  • Tackling Dependencies in LSAF
  • Conclusion
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San Diego Parsippany

FICSA

FCT UK

IPC DK Ferring Japan IPC India BTG Israel FGLAG Ferring China

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Parsippany

Ferring China IPC DK Ferring Japan

Presence in all development centres

resources, expertise, technology, standards

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Ferring TCS CRO

  • same systems
  • same processes
  • communication
  • continuity
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SDTM ADaM

End-of-text material Narratives Safety Monitoring

Clinical Trial

JMP Qlik Medical In text tables Patient Profiles

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Copy, Run & Lock

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

Conduct

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

DBL

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

CTR

SDTM ADaM

End-of-text material Narratives

Clinical Trial

In text tables

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Programming Plan

  • Name of

program

  • Programmer
  • Date
  • Validator
  • Validation

status

Validation Report

  • Name of

program

  • Programmer
  • Date
  • Validator
  • Validation

status

Program Header

  • Name of

program

  • Programmer
  • Date

Copy, Run & Lock

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

Conduct

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

DBL

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

CTR

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SDTM ADaM

Safety Monitoring JMP Qlik Medical Patient Profiles

Copy, Run & Lock

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

Conduct

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

DBL

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

CTR

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Copy, Run & Lock

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

Conduct

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

DBL

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

CTR

Programming Plan

  • Name of

program

  • Programmer
  • Date
  • Validator
  • Validation

status

Validation Report

  • Name of

program

  • Programmer
  • Date
  • Validator
  • Validation

status

Program Header

  • Name of

program

  • Programmer
  • Date
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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation Plans at Ferring
  • Tackling Dependencies in LSAF
  • Conclusion
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Life Cycle Management Industry Examples

“Horizontal” “Copy, Run & Lock” “Vertical” “Tag-based”

CSR Development Validation Production Dataset Macro Program Output Dataset Macro Program Output Dataset Macro Program Output Current CSR Dataset Macro Program Output Dataset Macro Program Output DB Lock Dataset Macro Program Output Trial Dataset Macro Program Output lisAE.sas 0.1 AE.sas7bdat 1.0 listing.sas 1.0 listing.sas 2.0 lisAE.sas 0.2 lisAE.sas 1.0 lisAE.sas 2.0 lisAE.txt 1.0 lisAE.txt 2.0 AE.sas7bdat 2.0

CSR CSR CSR CSR

lisAE.sas 1.1

DBL DBL DBL DBL

CSR Dataset Macro Program Output lisAE.sas 0.1 AE.sas7bdat 1.0 listing.sas 1.0 listing.sas 2.0 lisAE.sas 0.2 lisAE.sas 1.0 lisAE.sas 1.1 lisAE.txt 1.0 lisAE.txt 1.1

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LSAF Features (1) Versioning in LSAF

  • Possibility to enable and disable versioning
  • New versions created at check-in and check-out or when files are overwritten
  • Each time a user modifies a program under versioning, a new version is

created as next Major, Minor or Custom version.

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LSAF Features (2) eSignature in LSAF

  • Versions can be eSigned with different roles and reasons
  • Roles and reasons can be customized
  • eSignatures are not carried forward from one version to the next
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LSAF Features (3) Using the LSAF APIs...

%LSAF_GETCHILDREN %LSAF_GETSIGNATURES %LSAF_GETVERSION 1 row per program 1 row per program and version 1 row per version and eSign

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Status Versioned Checked out Program Author signed Program Approver signed Rejected Yes No Approve Reject Validated Yes No Approve Approve

Derive Validation Status

Program Status

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Status Versioned Checked out Program Author signed Program Approver signed Rejected Yes No Approve Reject Validated Yes No Approve Approve Not yet started* NA NA NA NA Ongoing Yes / No Yes Yes / No Yes / No Draft not versioned No No No No Draft versioned Yes No No No Ready for validation Yes No Approve No Signed not versioned No No Yes / No** Yes / No**

* Available in Programming Plan but not in LSAF ** At least one has to be yes

Derive Validation Status

Program Status

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Issue Description 1 Program author signed as ‘Reject’ 2 Program author and program approver is the same 3 Program approver signed before program author 4 Program approver missing in Programming Plan but present in LSAF 5 Progam author is missing in Programming Plan but present in LSAF 6 Programmer checked in not signed as Program author 7 Program approver has signed but program author has not signed 8 Programming Plan author is different from actual in in LSAF 9 Programming Plan approver is diffrent from actual in LSAF 10 Program not listed in Programming Plan 11 Unknown issue

Derive Validation Status

Potential Issues

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Ferring Study Dashboard

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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation at Ferring
  • Future Plans at Ferring
  • Conclusion
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Copy, Run & Lock

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

Conduct

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

DBL

  • Datasets
  • Programs
  • Macros
  • Logfiles
  • Output

CTR

Programming Plan

  • Name of

program

  • Programmer
  • Date
  • Validator
  • Validation

status

Validation Report

  • Name of

program

  • Programmer
  • Date
  • Validator
  • Validation

status

Program Header

  • Name of

program

  • Programmer
  • Date
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Specification

e.g. SAP, ADS

Develop program

eSign ‘approve’

Validate

eSign ‘Reject’ eSign ‘Approve’ Validated program

Not OK

Specification Author Program Author Program Approver Output

OK

Sign & Version

  • Not versioned

Datasets

  • Versioning
  • Signing

Programs

  • Versioning
  • Signing

Macros

  • Not versioned
  • Snapshot at delivery

Logfiles

  • Not versioned
  • Packages versioned

Outputs

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Step Responsible Action 1 Program Author Develop the program in the LSAF workspace. Check the program into the LSAF repository and turn on versioning. 2 Program Author Using the role ‘Author’ eSign the program indicating ‘Approve’ including a comment that this is the first version. If the validation level is not available elsewhere it must be included in the comment . 3 Program Approver Validate according to the specified validation level. In case of findings continue to step 4. In case of no findings continue to step 8. 4 Program Approver Using the role ‘Approver’ eSign the program indicating ‘Reject’ including the validation finding(s) as a comment. If an update to the specification is required then continue to step 5. If an update to the program is required then continue to step 6. 5 Specification Author Update the specification according to the validation findings. 6 Program author Check the program out from the LSAF repository. Update the program according to the validation findings. Check the program back into the LSAF repository. 7 Program author Using the role ‘Author’ eSign the program indicating ‘Approve’ including a comment addressing the validation finding(s). Repeat the process starting from step 3. 8 Program Approver Using the role ‘Approver’ eSign the program indicating ‘Approve’ including a comment that the validation has been completed, e.g. ‘No deviation found’.

Sign & Version

  • Not versioned

Datasets

  • Versioning
  • Signing

Programs

  • Versioning
  • Signing

Macros

  • Not versioned
  • Snapshot at delivery

Logfiles

  • Not versioned
  • Packages versioned

Outputs

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Sign & Version

  • Not versioned

Datasets

  • Versioning
  • Signing

Programs

  • Versioning
  • Signing

Macros

  • Not versioned
  • Snapshot at delivery

Logfiles

  • Not versioned
  • Packages versioned

Outputs

Programming Plan

  • Name of

program

  • Programmer
  • Validator

Validation Report

  • Generated

from metadata

Program Header

  • Name of

program

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SDTM ADaM

End-of-text material Narratives Safety Monitoring

Clinical Trial

JMP Qlik Medical In text tables Patient Profiles

Sign & Version

  • Not versioned

Datasets

  • Versioning
  • Signing

Programs

  • Versioning
  • Signing

Macros

  • Not versioned
  • Snapshot at delivery

Logfiles

  • Not versioned
  • Packages versioned

Outputs

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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation at Ferring
  • Future Plans at Ferring
  • Conclusion
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Future Roadmap

  • Can be executed for libraries where we don’t have progplans.
  • Sync with Validation report for all program entries and their validator credentials.

Program Status Utility

  • Provide snapshots of artifacts current at a given date (Programs, Jobs, Macros etc.)
  • Add version and program status in footnotes for all output
  • Extend to a full validation report

Ideas for Related Utilities

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Validation Report

Version User Role Date / time Decision Comment 1.00 XXXX Author

  • 6. jul. 2018 10:00

Approve Ready for validation 1.00 YYYY Approver

  • 7. jul 2018 14.16

Reject Validation finding 1.01 XXXX Author

  • 8. jul. 2018 11:16

Approve Finding addressed 1.01 YYYY Approver

  • 9. jul 2018 11.53

Approve No deviation found

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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation Plans at Ferring
  • Future Plans at Ferring
  • Tackling Dependencies in LSAF
  • Conclusion
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Tackling Dependencies (1) How to consider status of dependent artefacts?

Program Macro 1 Macro 2 Macro 3

Output

Log Lst

Status?

Dataset 1 Dataset 2 Dataset 3

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Tackling Dependencies (2) What is a job?

  • Executes SAS programs as a background process
  • Represents a single SAS session with a shared WORK library
  • Lists all inputs and outputs
  • Inputs can be specified as “Latest” or pointing to a specific

version

  • Jobs information can be read using LSAF APIs
  • Produce a job manifest with all execution information
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Tackling Dependencies (3) Expand Validation Status to Inputs and Outputs

Program Macro 1 Macro 2 Macro 3 Job

Output

Log Lst

Central Object under versioning and for eSign?

Dataset 1 Dataset 2 Dataset 3

Manifest

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Agenda

  • Background at Ferring
  • Supporting Life Cycle Management in LSAF
  • Business Implementation Plans at Ferring
  • Tackling Dependencies in LSAF
  • Conclusion
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Conclusion

Status information is computed from programmer and validator eSignatures:

  • All operational information is programmatically retrievable using LSAF APIs
  • Cannot be out of Sync with ”ProgPlan” by Design!

Inadvertent changes will result in a new verison with status Draft or the deletion of eSignatures if the program is not under versioning. Human errors can easily be tracked in the system and reported. Process assumes that users turn on versioning at the latest when code is ready for validation. Metrics on programming iterations needed can be captured and provide feedback to management on team performance, standard program needs or training. Concepts can be extended to tackle dependencies by analysing jobs and their manifests