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Clinical Trials Programming Using SAS 9.4 — Information & Free Practice

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About Clinical Trials Programming Using SAS 9.4

Clinical Trials Programming Using SAS 9.4 · US

Key exam facts

Provider
SAS and Pearson VUE
Format
Multiple choice and short-answer questions; short answers may require a numeric answer or a short section of SAS code.
Exam questions
Total questions: 60–70.
Time limit
1 hour 50 minutes
Passing score
68%
Exam fee
USD 180; academic discounts may apply.

Topics covered

  • Clinical Trials Process (5%)

    • Clinical research phases, roles and organizations
    • Programming requirements from SAP and annotated case report forms

  • Clinical Trials Data Structures (10%)

    • Clinical trials domains
    • CDISC principles and terminology
    • CDISC SDTM structure and purpose
    • CDISC ADaM structure and purpose
    • Trace raw data through programming to mapped domains

  • Regulatory Submissions (5%)

    • Regulatory requirements for SAS V5 exported data sets
    • Contents and purpose of define.xml

  • Manage Clinical Trials Data (5%)

    • DICTIONARY tables through PROC SQL
    • Input-data exploration, outliers, missing values and errors

  • Transform or Summarize Clinical Trials Data (15%)

    • Derive variables with categorization and windowing
    • Store and check clinical-trials dates using ISO 8601
    • Reshape data with PROC TRANSPOSE and DATA-step arrays
    • Calculate change from baseline
    • Count clinical-trials events
    • FIRST./LAST. variables

  • Apply Statistical Procedures for Clinical Trials (15%)

    • Descriptive statistics with SAS procedures
    • Select analyses according to data types
    • Identify syntax and semantic errors in statistical procedure code
    • Create output data sets from statistical procedures
    • Program safety and efficacy data following instructions

  • Macro Programming for Clinical Trials (15%)

    • Create macro variables and set parameters
    • Access user-defined and automatic variables
    • Define and call macros to automate tasks
    • Debug macros and display values in the SAS log

  • Report Clinical Trials Results (10%)

    • Tables and listings with PROC REPORT
    • Produce and augment reports with ODS
    • Create, group, overlay and customize graphs

  • Validate Clinical Trial Data Reporting (20%)

    • Programming-validation principles in clinical trials
    • Validate reporting with the SAS log
    • Validation with PROC COMPARE and MSGLEVEL
    • Explain differences between independent validation programs
    • Elements not validated by PROC COMPARE
    • Identify and resolve data, syntax and logic errors

How to prepare

Work through the topics, read the explanation after each answer, and revisit the areas where you miss questions. Use the official outline and reference materials below to guide your study.

These independent practice questions are not actual exam items and do not guarantee a passing result.

Frequently asked questions

What is the exam format?

Multiple choice and short-answer questions; short answers may require a numeric answer or a short section of SAS code.

How many questions are on the exam?

Total questions: 60–70.

How long is the exam?

1 hour 50 minutes

What is the passing score?

68%

How much does the exam cost?

USD 180; academic discounts may apply.

Official sources and references

Confirm current exam arrangements with the exam provider.