SGS clinical CDASH metadata and terminology

CDASH at present: conformance rules• All Highly Recommended and applicable Recommended / Conditional fields are present in the CRF • All code lists displayed in the CRF use or map to cu

London, United Kingdom 28th – 29th April 2010

Session 2, 11:00 - 12:30 CDASH – Right from the Beginning Chair: Niels Both

Getting the Most out of CDASH, Metadata and Terminology

Joris De Bondt, Data Management Coordinator SGS Life Science Services

CDASH in the past

• Many benefits

– CDASH provides benefits for the site and monitors

• efficient CRF data completion and efficient monitoring

– CDASH solves a number of SDTM challenges

• standard CRF pages have standard SDTM annotations

• reduce the need for sponsor-specific controlled terminology

– CDASH reduces eCRF set-up time for eCRF-tools with library capabilities

• Drag and drop CDASH forms into the study design

– CDASH is a key-item for a true end-to-end CDISC

CDASH in the past

• But even more questions

– Can we define additional CDASH domains ourselves?

– Can we customize the 16 CDASH domains?

– What is required to be CDASH compliant?

– What’s the experience of others with CDASH?

CDASH at present

• CRF customization seems to be in our nature:

– Can we turn the vertical structure into a horizontal structure?

– Can we change the order of the CDASH fields?

– Can we mix fields from one domain with another?

• So, the question is:

“What is CDASH conformance?”

CDASH at present: conformance rules

CDASH at present: conformance rules

• All Highly Recommended and applicable Recommended /

Conditional fields are present in the CRF

• All code lists displayed in the CRF use or map to current published

CDISC Controlled Terminology

• The implementation follows the Best Practice recommendations

for creating data collection instruments

= FAQ list with 12 items

• CDASH Question Text or Prompt is used

CDASH at present: conformance rules

• All Level 1 conformances are met

• All data collection fields are defined using CDASH naming conventions in the operational database

• All non-CDASH fields in CRF follow CDASH recommendations for

‘creating fields that do not exist in CDASH’

• All Best Practice recommendations are followed

CDASH at present

• Answers

– Can we define additional CDASH domains ourselves?

• Yes, the CDASH user guide provides instructions

– Can we customize the 16 CDASH domains?

• Using subsets, changing the field order and mixing fields across domains is allowed

– What is required to be CDASH compliant?

• Comply with CDASH conformance rules in the CDASH user guide

– What’s the experience of others with CDASH?

• That’s what CDISC interchanges are for!

CDASH at present: Implement now

• Create a library with the CDASH-ODM files in your CRF design tool

• Add completion instructions to all CDASH fields => generate the Completion Guidelines document when the CRF design is done

CDASH at present: Implement now

– CDASH naming conventions

Goal = end-to-end tracebility till SDTM

“VSORRES” in CDASH standard

“evtSCREENING.frmVS.secHEIGTH.VSORRES” in operational database

– What works in your system?

CDASH at present: Implement now

– End-to-end tracebility till SDTM
great EDC features

• Some EDC systems allow built-in AE-CM linking (split screen)

– But CDASH naming cannot be applied for this RELREC data

– Trade-off: User friendly
full CDASH compliance

CDASH in the future

• Getting the Most out of CDASH, Metadata and Terminology: opportunities

– 2 case studies:

• Metadata repository

• Drug safety and clinical research

CDASH in the future: Case 1

(+define.xml and annotated CRF)

Extract-Transform-Load

CDASH in the future: Case 1

CDASH in the future: Case 1

• Add a new dimension to your trials:

– Use Metadata from the start

• Pull the CRF forms for all your

trials out of a metadata repositoryinto the CRF design tool

CDASH in the future: Case 1

• Add a new dimension to your trials:

– Use Metadata during the trial

• Verify consistency of your trials

before Go-Live

• Use the metadata repository to

update the trial design in case

of protocol amendments

• Store the trial metadata in the metadata repository for future reference

Metadata Repository

CDASH in the future: Case 1

• Add a new dimension to your trials:

– Use Metadata till the end

• Use the trial metadata in the metadata repository to generate

SDTM datasets

CDASH in the future: Case 1

• Enhanced flow: Metadata all the way

Metadata Repository

CDASH in the future: Case 1

• Enhanced flow: Metadata all the way

– Benefits

• Full control over the trial metadata from the start till the end

• A metadata repository provides a unique source of information on a cross-trial level

CDASH in the future: Case 2

• Drug safety
clinical research

– Remove the barrier between Drug Safety and Clinical Research

• CDASH could include the data fields typically submitted in an Individual Case Safety Report (ICSR)

• Content of ICSR is known as E2B

– By creating CDASH – E2B mappings

• Mapping exercise for 320 fields is ongoing

CDASH in the future: Case 2

• Drug safety & clinical research

– 2 huge time-savers

• Automatic upload of SAE reports in safety databases

• Automated SAE reconcilation of the clinical database with the safety database via SDTM – E2B mapping

CDASH in the future: Case 2

• Drug safety & clinical research

– CDASH user guide provides answers

– CDASH conformance includes the operational level

– End-to-end (CRF-to-SDTM) tracebility

– Metadata all the way

– Integrated CDISC process generates opportunities

Thank you for your attention

Strength through collaboration.