FOR FREE DEMO contact :
Phone/WhatsApp : +91-(850) 012-2107
USA Number : 214-628-3894

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.