Question 1

What are CDISC standards and why are they required for regulatory submissions?

Accepted Answer

CDISC (Clinical Data Interchange Standards Consortium) standards define how clinical trial data must be structured and formatted for regulatory submissions. The FDA has mandated CDISC SDTM and ADaM compliance for all new NDA, BLA, and ANDA submissions since 2016, and the PMDA requires them for submissions in Japan. Compliance ensures regulators can efficiently review and analyse trial data using standardised tools.

Question 2

What is the difference between SDTM and ADaM in CDISC?

Accepted Answer

SDTM (Study Data Tabulation Model) organises collected clinical data into standardised domains that mirror the raw data — such as Demographics (DM), Adverse Events (AE), and Laboratory Results (LB). ADaM (Analysis Data Model) builds on SDTM to create analysis-ready datasets with derived variables, baseline flags, and analysis populations. Both are required for a complete regulatory submission package.

Question 3

How does IDDCR implement CDISC standards for a new study?

Accepted Answer

IDDCR begins CDISC implementation at study design — creating a CDISC-compliant annotated CRF (aCRF) and SDTM mapping specifications before data collection starts. This upstream approach prevents costly data transformation at the end of the study. Our team builds SDTM and ADaM datasets from the mapping specs, produces define.xml, and validates all outputs against CDISC Pinnacle 21 and FDA validation rules.

Question 4

What is Pinnacle 21 and does IDDCR use it?

Accepted Answer

Pinnacle 21 (formerly OpenCDISC) is the industry-standard validation tool used by the FDA to check CDISC dataset compliance. IDDCR runs all SDTM and ADaM datasets through Pinnacle 21 Enterprise before submission, resolving errors and documenting justifications for any warnings that cannot be resolved. This ensures datasets pass FDA validation checks and reduces the risk of technical rejection.

Question 5

Can IDDCR retrofit legacy data to CDISC standards?

Accepted Answer

Yes. IDDCR has experience converting legacy non-CDISC datasets — from older SAS transport files, Access databases, or paper-based studies — into CDISC-compliant SDTM and ADaM formats. This is common for lifecycle management submissions, paediatric studies, or when combining historical data with new trial data. We provide full traceability documentation mapping source variables to CDISC domains.

CDISC Standards

Our Approach to CDISC Standards

Core Capabilities

CDASH Implementation

SDTM Implementation

ADaM Implementation

Define-XML & Metadata

CDISC Compliance Review

CDISC Training & Consulting

Therapeutic Areas

Development Phases

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Clinical Trial Management

Clinical Data Management

Biostatistics

Statistical Programming

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