CDISC Data Standards SDTM and AdaM
Clinical Data Interchange Standards Consortium (CDISC), founded in 1997, is a global non-profit data standards organization that works for enhancing the impact of clinical research by developing data standards for the accumulation, analysis, and transmission of clinical data. CDISC membership consists of a broad range of groups, including the pharmaceutical sector, biotechnology firms, clinical research centers, technology service providers, healthcare providers, academic institutions, government agencies, and much more. Since CDISC makes the process of analyzing data more efficient, regulatory bodies strictly recommend the use of CDISC.
SDTM and ADaM
CDISC supports two major standards– SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). Though the implementation of CDISC standards can increase development expenses, you can minimize the costs by identifying the right implementation process and picking the right technology. Besides streamlining processes, the implementation of CDISC standards enhances innovation, fosters efficiency, improves data quality, minimizes expenses, and increases predictability.
Role of SDTM in Preparing Data Submissions
The SDTM is the standard format for the submission of tabulation data to the FDA. In 2004, the SDTM was declared as the standard format for submitting data related to clinical studies, and in 2011, it was chosen as the standard format for submitting non-clinical trials as well. Since clinical and non-clinical data submissions must conform to SDTM format, data managers must acquire proficiency in the SDTM for seamless data submissions. SDTM brings you the following advantages:
• Facilitates uniformity across studies;
• Facilitates data consistency;
• Calls for less work per study;
• Minimizes chances of errors;
• Eliminates the need for learning organization-specific dataset formats;
• Makes it easy for reviewers to comprehend your submission;
• Facilitates easy cross-platform Data Interchange;
• You get a global community to assist you with all questions.
Though SDTM is the leading standard for communicating clinical information, it is still evolving, and calls for additional documentation and effort.
Role of ADaM
Clinical as well as non-clinical studies require ADaM or Analysis Dataset Model. This model identifies the basic principles and standards to make sure there is a clear sequence of information starting from data collection to data analysis.
The ADaM model defines dataset and metadata parameters for facilitating the seamless generation, replication, and evaluation of clinical trial statistical investigations. The concept of ADaM is relatively new in the domain of clinical investigation. The Analysis Dataset Model (ADaM) v0.7 was first created in 2005 by reviewers proficient in clinical studies and regulatory submissions. Due to the ever-increasing need for standardized datasets for regulatory submissions, the popularity of ADaM datasets is increasing by leaps and bounds.
Since ADaM provides a solid framework for statistical programmers, it can be easily implemented by statisticians. However, the AdaM datasets should only be derived from SDTM datasets. You do not need ADaM datasets unless you derive the data based on SDTM.
Benefits of AdaM
• ADaM caters to the majority of clinical data analysis requirements.
• ADaM is not as rigid as SDTM and offers a lot of flexibility.
• It is compatible with Define-XML (metadata about SDTM and AdaM submissions).
• ADaM datasets have inbuilt traceability.
• Like SDTM, ADaM datasets can also be submitted to regulatory agencies.
Both SDTM and ADaM datasets are necessary for drugs/product approval. Both models aim at precisely communicating the source and content of datasets submitted to underpin the statistical analysis performed by sponsors.
While both ADaM and SDTM seem straightforward to implement, getting the correct framework, relationships, and metadata calls for extensive planning. Nevertheless, the fact remains that data standardization allows for interoperability between software, analysts, and organizations. The SDTM data sets provide standards for organizing clinical trial data following database lock. And the ADaM data sets provide a connection between the SDTM data sets and final statistical analyses. CDISC standards are intended to provide drug and device developers with more clarity into clinical research.
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