Clinical study data processes @ leo pharma
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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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Clinical study data processes @ leo pharma

Clinical Study DataProcesses@ LEO Pharma


Process overview

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


Data capture and management

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


Standards and validation

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


Tfl and statistics

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


Reporting and submission

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


Qc processes

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)


Conclusions

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


Questions

Questions


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