New CDISC Build
Create specifications and datasets from source data using study standards.
CDISC
CDISC & Submission-Ready Deliverables
Build, validate or rescue a traceable clinical data package from SDTM and ADaM through TFLs, Define-XML and reviewer documentation.
STARTING POINT
Common Starting Points
We can start from raw/EDC data, existing SDTM, partial ADaM or an existing package requiring review.
Validation / Independent QC
Review datasets, metadata and outputs using programmed checks and independent validation.
Rescue / Remediation
Resolve structural, traceability or consistency problems without rebuilding more than necessary.
FLOW
Submission Package Flow
Traceability connects source data, standardized datasets, analysis datasets and outputs, while metadata and reviewer documentation develop alongside the corresponding package.
01Source Data
02SDTM
03ADaM
04TFLs
Metadata & review documentation
aCRF / SDTM specs
SDTM Define-XML
ADaM specs
ADaM Define-XML
SDRG
ADRG
Pinnacle 21 issue documentation
OUTPUTS
Typical Deliverables
Depending on scope, the package may include:
Data & Metadata
- Annotated CRF (aCRF)
- SDTM specifications and datasets
- ADaM specifications and datasets
- Tables, figures and listings
Documentation
- Define-XML
- SDRG
- ADRG
- Pinnacle 21 review and issue documentation
Have an existing package that is difficult to validate or explain?
Send the current specifications, datasets and validation findings. We can help determine whether the answer is QC, remediation or rebuild.