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 dependence of statistical 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 standardize this documentation.

Course Duration

  • Duration of CDISC - SDTM course is 1 Month

Course Modules:

  • Understanding of SDTM Implementation Guide
    • Basic of SDTM Domains
    • CDISC Variable types and their importance
    • Fundamentals of CDISC SDTM
    • Special Purpose Domains
    • Creating Custom SDTM Domains
    • Timing variables in SDTM
    • CDISC SDTM core variables
    • Supplemental Qualifiers
    • Dealing with Non standard data.
    • Controlled terminology and different types in it.
    • SDTM Assumptions
    • Special Purpose Domains (DM,CO,SE,SV)
    • Interventions(CM, SU, EX, PR)
    • Events(AE,CE,DS,DV,HO,MH)
    • Findings(DA, PE, VS, LAB, IE, QS, RP, SS, ECG)
  • Annotation of Annotated CRF as per SDTM
  • Creation of Mapping/Metadata Specification as per SDTM Guidelines
  • Creation of different SDTM Datasets(DM, AE etc)
  • Creation of Trial Design Domain datasets
  • Programming of Various Standard SDTM Macros like study day, empty dataset etc
  • SDTM datasets validation and resolution
  • FDA Submission standards of SDTM

ADaM:

  • ADSL Subject level information basics
  • BDS basics
  • ADAM Implementation Rules
  • Creation of Adam Metadata Specification
  • Creation of ADAM datasets (ADSL and BDS dataset)
  • ADAM datasets validation and resolution
  • Creation of ADAM Define.XML
  • Creation of Analysis Data Reviewer's Guide
  • FDA Submission standards of ADAM datasets

TABLES:

  • Creation of Safety tables
  • Creation of Efficacy tables
  • Calculation of treatment variables, study day etc.
  • During the training period the following modules will be covered as a part of Student career Improvement Program.

  • Communication and Soft skill development
  • Just A Minute Sessions
  • Seminars
  • Case studies
  • Mock interviews
  • Guest lectures
  • Student improvement program
  • Professional career building
  • Organizing Resume
  • Knowledge Sharing on new techniques