Implementation of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) in Investigator-Initiated Studies on Hematologic Malignancies
13 Pages Posted: 28 Oct 2022
Abstract
The standardization of clinical data is important for quality control to ensure reliability, efficiency for early development, and the possibility of secondary use. In cases of investigator-initiated studies (IISs), clinical data are not standardized, and new metadata are created for each study, greatly wasting time, resources, and labor worldwide. The Clinical Data Interchange Standards Consortium (CDISC) was established as a volunteer consortium providing data standards for clinical trials. The data standards have been used by the Food and Drug Administration and Pharmaceuticals and Medical Devices Agency in drug trials for approval in all medical areas. However, in IISs, the use of the CDISC standard is very rare [1] [2] . To implement CDISC standards for IISs in hematologic malignancies, where there are no therapeutic area standards (TAS)provided by the CDISC, we established a team comprised of a biostatistician, data manager, and hemato-oncologist (medical doctor). We first developed concept maps for hematologic malignancies and subsequently generated mapping specifications for each clinical research. Thereafter, the mapping issues were summarized. After mapping 27 IISs, we fixed the concept maps, specifications of mappings, and known issues. Results have shown that, after experiencing a lot of mapping in one medical area, mapping specifications can be narrowed down, and known issues specific to the medical area can be revealed and fixed. Sharing specifications and known issues will omit unnecessary efforts to solve the same mapping problems in the field of hematologic malignancies, including leukemia and lymphoma.
Note:
Funding Information: Funding was provided by National Hospital Organization Nagoya Medical Center.
Declaration of Interests: The authors have no competing interests to declare.
Keywords: CDISC, SDTM, Medical Informatics, Hematologic Neoplasms, Leukemia, Lymphoma
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