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Clinical research Training clinical data management Course with SAS and Imaging by Clinnovo

CDISC - SDTM - ADaM

  • SDTM stands for Standard Data Tabulation Model defined by Clinical Data Interchange Standards Consortium (CDISC). SDTM defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted to a regulatory authority like FDA as part of a product application. SDTM standard is widely used in the industry, such requirements were standardized and are broadly shared. SDTM should be followed by Data Manager while designing eCRF. SDTM bridges the gap between data manager and statistician by eliminating the dependancy of stastistical programmer. Particular requirements of statisticians and modeling scientists for data formats are known and understood by SDTM. SDTM increase the efficiency of the drug development process. SDTM gives a more consistent and robust CDM approach compared to collecting the clinical data in CDISC standard.


    ADaM stands for Analysis Data Model defined by Clinical Data Interchange Standards Consortium (CDISC). ADaM defines a standard for Analysis Dataset’s to be submitted to the regulatory authority like FDA. This provides a clear content, source, and quality of the datasets submitted in support of the statistical analysis performed by the sponsor. The principle of clear and unambiguous communication, relies on clear AD's (Analysis datasets) documentation. ADaM helps to statndardise this documentation.

  • Course modules:

    ADaM:

    TABLES:

    During the training period thefollowing modules will be covered as a part of Student career Improvement Program.

    For more information please contact at 9912868928


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