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SAS Clinical Interview Questions and Answers, Recorded Video Sessions, Materials, Mock Interviews Assignments Will be provided
SAS CLINICAL COURSE CONTENT
(the course agenda can be modified as per your requirements):

Clinical Process Using SAS
  • Describe the clinical research process (phases, key roles, key organizations)
  • Interpret a Statistical Analysis Plan.
  • Accessing, managing and transforming clinical trials data.
  • Derive programming requirements from an SAP and an annotated Case Report.
  • Statistical procedures and macro programming.
  • Reporting clinical trials results.
  • Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices)
Clinical Trials Data Structures
  • Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.)
  • Key personnel in companies must be committed to implementing the CDISC/CDASH standards.
  • Identify key CDISC principles and terms.
  • Describe the structure and purpose of the CDISC SDTM data model
  • Describe the structure and purpose of the CDISC ADaM data model
  • Describe the contents and purpose of define.xml
  • Implementing the new standards that involves reorganizing the operations (of an organization) so as to improve efficiency [processes and SOPs].
  • Data management staff [CDM, clinical programmers], biostatisticians, and clinical monitors may find it difficult to converge on a new standard when designing standard libraries and processes.
Import and Export Clinical Trials Data
  • Learn how many types of data that are critical for integration.
  • Learn at what point the data should be imported into Express.
  • Apply regulatory requirements to export SAS data sets (SAS V5 requirements).
  • Subsequent data reconciliation process that is required to ensure all integrated data is done so correctly.
  • The impact integration has on exporting data from Express
Manage Clinical Trials Data
  • Role of the clinical data manager in a clinical trial.
  • Access DICTIONARY Tables using the SQL procedure.
  • Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).
  • Database design and build
  • Computer system validation (CSV)
  • CDISC
  • Validation rules
  • Serious adverse event reconciliation
  • Metrics and tracking
Transform Clinical Trials Data
  • Apply categorization and windowing techniques to clinical trials data.
  • Crowd sourcing will transform trial participation
  • Transpose SAS data sets.
  • Apply ‘observation carry forward’ techniques to clinical trials data (LOCF, BOCF, WOCF).
  • Calculate ‘change from baseline’ results.
  • Obtain counts of events in clinical trials.
  • Mobile Computing and Data Gathering.
  • Social Media’s Influence on Clinical Trials
Apply Statistical Procedures For Clinical Trials
  • Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY)
  • Use PROC FREQ to obtain p-values for categorical data (2×2 and NxP test for association)
  • Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests)
  • Create output data sets from statistical procedures.
Macro Programming For Clinical Trials
  • Create and use user-defined and automatic macro variables.
  • Automate programs by defining and calling macros.
  • Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).
  • Successful Process Improvement using Validated SAS Macros in Clinical Trial Reporting.
  • Ensuring Usage of Newly Developed Macros.
  • Benefits of New SAS Macros.
Report Clinical Trials Results
  • How to Register a Clinical Trial.
  • How to Report Clinical Trial Results.
  • Use PROC REPORT to produce tables and listings for clinical trials.
  • Reports Use ODS and global statements to produce and augment clinical trials reports.
  • Sharing and Reporting the Results of Clinical Trials - The principle of data sharing dates to the dawn of scientific discovery.
Validate Clinical Trial Data Reporting
  • Explain the principles of programming validation in the clinical trial industry.
  • Utilize the log file to validate clinical trial data reporting.
  • Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
  • Identify and Resolve data syntax and logic errors.
  • Reporting and statistics.