Many Sponsors use CDISC standards when creating databases for new clinical studies. Regulatory authorities encourage the use of CDISC as it has made the process of reviewing and examining information more efficient. CROS NT discusses strategies for applying standardization in current clinical development programs and how to minimize the cost of mapping and converting data.
Conversion to CDISC standards generally includes SDTM, ADaM and CDASH. Adopting and implementing these standards can increase development costs, but identifying the right process for implementation and choosing the appropriate technology can reduce these costs. It is important to start implementing CDISC standards during data collection by having Data Managers design the CRF using CDASH standards. This makes the process of mapping data into SDTM and ADaM datasets much more straightforward.
Preparing a Data Mapping Project
When requesting the mapping of CDISC standards, requesting the following deliverables will ensure a structured and validated approach:
1. Project Plan and Project Charter to establish contacts, timelines, frequency of status reports, project risks and issue resolution procedure
2. Standardized Data using SDTM format, including the source of the original data (specify version of SAS to be used)
3. Mapping Documents between the source and target data, to provide traceability information
4. Data Status Table containing the different source data characteristics including quantitative and qualitative measurements
5. Metadata File (define.xml)
6. Mapping program files and execution logs (.log) which document the mapping process
7. Reviewers Guide which contains a detailed description of the mapping rules and source data types for each study
8. Validation Certificate containing signed reports of quality control checks including resumes/CVs of personnel involved
Data Repository for Information Management and Cost Reduction
Implementing CDISC standards means adopting technologies that can manage the flow of data and information. Keeping clinical data in multiple repositories can create a complex management process and is often prone to error. Setting up a central database for all data allows for an easier mapping process.
Centralized data storage provides the following benefits:
- Cost: Avoid paying multiple CROs to set up a global library, program macros and perform validation checks
- Efficiency and Time: when the team is already familiar with Sponsor requirements the review cycle reduces
- Quality: measurement scales, design features, outputs and summaries all become standardized
- Access to Data: Reporting and access to data becomes much more straightforward. Clinical data visualization tools can be used by Sponsors to obtain important information including safety and efficacy data and study progress reports.
CROS NT and CDISC Mapping
CROS NT is a CDISC Gold Member, meaning it has constant access to new data standards and new documentation regarding CDISC standards. We help pharma, biotech and medical device companies incorporate CDASH, SDTM and ADaM standards into their organizations and map legacy studies to create the necessary consistency in formats. Our statistical programming team has developed macros to reduce time, costs and ensure consistency.
To learn more about how we can implement CDISC standards, send a request for information.