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Clinical Study Data Processes @ LEO Pharma

Clinical Study Data Processes @ LEO Pharma. Process overview. eDoc Define.xml Pooling Publish Submission. eCRF Oracle Clinical - MedDRA - WHO Drug CRO ’ s. CDISC - SDTM - ADaM - Controlled Terminology OpenCDISC. Tables Figures Listings Analyses 21 CFR part 11 - Repository.

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Clinical Study Data Processes @ LEO Pharma

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  1. Clinical Study DataProcesses@ LEO Pharma

  2. Process overview • eDoc • Define.xml • Pooling • Publish • Submission eCRF Oracle Clinical - MedDRA - WHO Drug CRO’s CDISC - SDTM - ADaM - Controlled Terminology OpenCDISC Tables Figures Listings Analyses 21 CFR part 11 - Repository QC

  3. Data Capture and Management CRF pages built in OC • Standardisation critical CRF pages from eCRF Data Management in OC • MedDRA • Who Drug CRO outsourcing • Standardisation critical SDTM • From 2005 • Standardisation benefit & critical OpenCDISC Validator • Standardisation benefit eCRF CRO OC CDC repository SDTM OpenCDISC Validator

  4. Standards and Validation Depends on standard SDTM ADaM since 2006 Standards allow for study variations Standards covers format, not contents Complex 21 CFR part 11 compliant CDC repository Metadata SDTM ADaM SAS Code SAPU

  5. TFL and Statistics Standardised/modifiable Parameter based Partly automated Configurable Analyses not standardised Analyses ad-hoc per study 21 CFR part 11 compliant CDC repository Metadata SDTM TFL SAS Code ADaM Spread sheet

  6. Reporting and Submission Not always performed Pooling dependent of standards define.xml ditto (documentation) If data standardised, submissions in weeks Closed transfer between validated systems 21 CFR part 11 compliant CDC repository Study data Pooled data define.xml eDoc etc. eDoc Publish

  7. QC processes Risk based QC strategy The most important and most critical parts Primary and secondary end points QC of additional parameters if applicable Applies to CRF, SDTM, ADaM, Tables, Listings, Figures, Analyses, Poolings, define.xml and everything else relevant Any deviation from standards requires additional QC Greater adherence to standards yields shorter production time of input to the CSR (months => weeks)

  8. Conclusions Clinical Study Data Processes are quite mature Years of experience in CDSIC standards 21 CFR part 11 compliant end-to-end Strong focus on standards yields • Automatisation • Flexibility • Quick CSR More elements needs to be standardised • Protocol, CRF, Figures, Analyses, define.xml, Pooling, Submissions, Data standards upgrades

  9. Questions

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