“We appreciate IA’s assistance with providing the datasets; it was short notice and we thank your team for the quick turn-around.”
How We Do Clinical Programming at Innovative Analytics
IA programmers support all stages of the of the collection, preparation, and presentation of clinical trial data. As database designers, the programmers work with project data managers and statisticians to translate study protocols into efficient data collection tools to ensure the accuracy of the data. By combining the content of the CDISC CDASH standards with a well-organized eCRF layout, active logical checks, and cohesive flow, the designers help to avoid issues with keyed data and thereby reduce time spent on monitoring activities. The programmers also produce post-entry data consistency reports for site-monitors and data managers.
With over 10 years of working with CDISC standards for submission datasets and supportive metadata materials, IA programmers generate all components of the submission data package that satisfy agency regulatory requirements. Source data are prospectively mapped to SDTM using CDISC standards and controlled terminology. Analysis datasets required to produce the SAP-specified TLFs follow the latest CDISC ADaM dataset conventions. Data traceability is fully documented through SDTM annotated CRFs, SAS® programs, define files, and reviewer’s guides according to sponsor’s requirements and specifications. IA programmers employ manual and programmed QC along with compliance tools, including Pinnacle 21, early and often throughout the data standardization process to ensure timely delivery of data tabulations and displays.
All deliverables from IA programmers (i.e. datasets, TLFs, and metadata documents) are verified prior to release to the client. QC methods range from manual visual checks to 100% dual-programmed data comparisons based on type and quantity of the data and the client’s requirements. Documentation is maintained that identifies the primary programmer, QC method/individual, and date finalized of each output. All data, programs, output, and supportive materials are provided on a close-out disk at the end of the study.
Innovative Analytics - The Smarter Approach
All IA SAS programmers have a master’s degree in Statistics or over 10 years industry experience. Clear and concise programs are developed to document the process as data moves from the clinical database to submission datasets, analyses, and output displays.
Overview of Services
Innovative Analytics offers the following Clinical Programming Services:
Database design
Custom reports for data review
External datafile handling and merges
Prospective CDISC SDTM and ADaM data standardization
Define file preparation including documentation support and data guides
TLF generation
Legacy dataset conversions to SDTM, ADaM
Dual programmed QC of deliverables
Integration of data files for ISS/ISE
