Real World CDISC Standards Support
Modern clinical research requires that biopharmaceutical companies, medical device companies, and their partners easily be able to exchange and review high-quality clinical trial data. The most widely accepted standards for clinical trial data are the CDISC (Clinical Data Interchange Standards Consortium) recommendations. For organizations that have not already implemented ways to support these CDISC standards, BioClinica offers training, implementation, and tools that can simplify this complex endeavor. Examples of this CDISC support include:
Compliance with CDISC CDASH and SDTM Standards
BioClinica understands how to implement and use the current CDISC standards CDASH (Clinical Data Acquisition Standards Harmonization) for data collection and SDTM (Study Data Tabulation Model) for data submissions. The CDISC CDASH standard was developed to address the Food and Drug Administration’s (FDA) Critical Path Initiative Opportunities: Consensus on Standards for Case Report Forms (CRFs). “A wide array of different forms and formats are used to collect clinical trial information, and most data are submitted to the FDA on paper. Differences in case report forms across sponsors and trials create opportunities for confusion and error,” states this document: http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf. The CDISC CDASH project is designed to address and correct this problem.
CDISC CDASH Compliance
BioClinica has multiple template CRF’s for each of the 16 CDISC CDASH domains available off the shelf, and has the capabilities to create custom CDASH CRF’s for your entire protocol. By using CDISC standards, your company will be able to reuse CRF forms which will gain efficiencies and cut costs by reducing data entry and monitoring errors. The clinical sites will require less training by using standard data collection methodology and the data will require less transformation prior to reporting to the FDA.
CDISC SDTM Compliance
Data is exported and delivered to you in submission ready CDISC SDTM domains. BioClinica will create a Domain Reference Guide that will show all of the mapping details about how the SDTM dataset is created. BioClinica understands all of the CDISC STDM variables that are required and will calculate and deliver all derived variables needed.
Sample SDTM SAS Dataset:
BioClinica can help your company understand and meet all CDISC standards. BioClinica offers CDISC consultation to help your company understand these standards and how they apply to your studies.
For additional information, please see “A Practical Introduction to Clinical Data Acquisition Standards Harmonization”*by Jennifer Price, the Senior Director of Clinical Solutions at BioClinica. Jennifer is a member of the CDASH core team and is currently working with the team on the CDISC CDASH user guide.