SDTM Conversion Programming & Validation

SDTM Conversion Programming & Validation

The SDTM (Study Data Tabulation Model) is a standard for human clinical trials (research) data tables and non-clinical data tables submitted by researchers to FDA and PMDA (Japan). The specification was developed by the Federation of Clinical data Exchange Standards (CDISC). Detailed information about FDA requirements is specified in FDA, NDA, ANDA and in some BLA submitted data standard directories. All SDTM data and metadata submitted to FDA will eventually be loaded into FDA's Janus data warehouse. The following picture (Figure 1) shows the CDISC SDTM submission process.

Figure 1. Overview of the CDISC SDTM submission process

A well-defined and detailed definition file speeds up the overall review process by minimizing the time required for FDA auditors to become familiar with the data. Therefore, SDTM structure is an important link in the process of scientific experiments and the key to the marketization of experimental results.

Our Services

Our experts will simplify the process of converting from SDTM/ADaM to NDA electronic submission, standardize data goals, ensure the consistency of attributes for each variable between data sets, define files and programming specifications, and avoid wasting time and resources to verify late consistency.

• SDTM conversion

The programming specification document is a key part of the SDTM conversion process because it is used for programming and verification, writing definition PDFs, and defining the generation of the main parts of the xml. There is a great need for a cost-effective way to ensure SDTM conversion meets the requirements described in the SDTM Implementation Guide and internal standards, and to ensure consistency between SDTM data sets, programming specifications, and definition files. Our SDTM service Guide covers a wide range of clinical and non-clinical experimental variables with programming specifications and define files. Consistency among them can be guaranteed. It avoids a waste of resources due to consistency checking. If there is any change in the SDTM dataset at any stage, we would update the data in the SDTM.

• SDTM validation

To ensure SDTM compliance, the list of available Web SDTM checks was investigated and replaced by an enhanced list of validation checks. Our service uses three main types of validation checks for SDTM validation: mapping, metadata, and data checking. With the introduction of the new SDTM version, validation checks were upgraded to ensure the correct conversion of the SDTM version. In addition, we will verify the data mapping specification to ensure the quality of the data conversion program.

We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee you cost-effective, complete and concise reports.

If you are unable to find the specific service you are looking for, please feel free to contact us.

References:

1. Anzai, T., Kaminishi, M., Sato, K., Kaufman, L., Iwata, H. and Nakae, D. (2015) ‘esponses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries’, Journal of Toxicologic Pathology, 28(2), 57-64.
2. Downing, N. S., Aminawung, J. A., Shah, N. D., Braunstein, J. B., Krumholz, H. M. and Ross, J. S.. (2012) ‘Regulatory Review of Novel Therapeutics - Comparison of Three Regulatory Agencies’, New England Journal of Medicine, 366(24), 2284-2293.