Validates a candidates’ ability to apply SAS programming skills to clinical trials data
Successful candidates should have experience in
- clinical trials process
- accessing, managing, and transforming clinical trials data
- statistical procedures and macro programming
- reporting clinical trials results
- validating clinical trial data reporting.
There are two methods available to earn this credential:
– pass the Clinical Trials Programming Using SAS 9 exam
or if you currently hold the SAS Certified Base Programmer for SAS 9 credential:
– pass the Clinical Trials Programming Using SAS 9 – Accelerated Version exam.
SAS Clinical Trials Exam A00-280 Requirement Details:
|Required Exam to Appear for Clinical Trials SAS Certification
Candidates who earn this credential will have earned a passing score on the Clinical Trials Programming Using SAS 9 exam. This exam is administered by SAS and Pearson VUE.
- 95-100 multiple-choice and short-answer questions (must achieve score of 70% correct to pass)
- 3 hours to complete exam
Use exam ID A00-280; required when registering with Pearson VUE.
SAS Clinical Trials Programming Exam topics Details:
|Clinical Trials Process
- Describe the clinical research process (phases, key roles, key organizations).
- Interpret a Statistical Analysis Plan.
- Derive programming requirements from an SAP and an annotated Case Report Form.
- 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.).
- Identify key CDISC principals 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.
|Import and Export Clinical Trials Data
- Combine SAS data sets.
- Efficiently import and subset SAS data sets.
- Access data in an Excel workbook (LIBNAME and PROC IMPORT/EXPORT).
- Create temporary and permanent SAS data sets.
- Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).
|Manage Clinical Trials Data
- Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ).
- Access DICTIONARY Tables using the SQL procedure.
- Sort observations in a SAS data set.
- Create and modify variable attributes using options and statements in the DATA step.
- Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).
|Transform Clinical Trials Data
- Process data using DO LOOPS.
- Process data using SAS arrays.
- Retain variables across observations.
- Use assignment statements in the DATA step.
- Apply categorization and windowing techniques to clinical trials data.
- Use SAS functions to convert character data to numeric and vice versa.
- Use SAS functions to manipulate character data, numeric data, and SAS date values.
- 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.
|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).
|Report Clinical Trials 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.
|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.
How to Prepare for SAS Clinical Trials Certification?
Experience is a critical component to becoming a SAS Certified Professional. These resources are designed to help you prepare.
SAS Clinical Trials Certification Online practice exams
SAS Clinical Trials Certification Questions PDF for A00-280
SAS Clinical Trials Certification Books:
- SAS Programming in the Pharmaceutical Industry, Second Edition
- Clinical Trials: A Practical Guide to Design, Analysis, and Reporting
- Introducing the CDISC Standards: New Efficiencies for Medical Research
- Validating Clinical Trial Data Reporting with SAS
- Implementing CDISC Using SAS: An End-to-End Guide