A00-280 Exam Format | Course Contents | Course Outline | Exam Syllabus | Exam Objectives
Test Detail:
The A00-280 Clinical Trials Programming Using SAS 9 test is administered by SAS Institute. It is designed to assess the knowledge and skills of individuals in clinical trials programming using SAS software. Here is a detailed overview of the test, including the number of questions and time, course outline, exam objectives, and exam syllabus.
Number of Questions and Time:
The A00-280 test consists of multiple-choice and short-answer questions that evaluate your understanding of clinical trials programming using SAS 9. The total number of questions and the time limit for the test may vary, but typically, the test includes:
- Number of Questions: Approximately 55 to 65 questions
- Time Limit: 105 to 120 minutes
Course Outline:
The A00-280 course covers a wide range of topics related to clinical trials programming using SAS 9. The course outline may include, but is not limited to, the following areas:
1. Introduction to SAS and Clinical Trials:
- SAS programming basics and syntax
- Introduction to clinical trials and the role of programming
2. Data Manipulation and Management:
- Importing and exporting data using SAS
- Data cleaning and validation
- Combining and merging datasets
3. Data Analysis and Reporting:
- Creating summary statistics and tables
- Generating patient profiles and listings
- Creating graphs and charts
4. Clinical Trials Programming Concepts:
- Clinical trial terminology and regulations
- CDISC (Clinical Data Interchange Standards Consortium) standards
- Quality control and validation of clinical trial data
5. SAS Macros:
- Introduction to SAS macros and macro variables
- Creating and using macros in clinical trials programming
- Automation and efficiency techniques using macros
Exam Objectives:
The objectives of the A00-280 test include:
- Assessing the candidate's knowledge of SAS programming fundamentals and syntax.
- Evaluating the ability to manipulate and manage clinical trial data using SAS.
- Testing the proficiency in analyzing and reporting clinical trial data using SAS.
- Assessing the understanding of clinical trials programming concepts and standards, including CDISC.
Exam Syllabus:
The A00-280 test syllabus covers various topics related to clinical trials programming using SAS 9, including, but not limited to:
- SAS programming fundamentals
- Importing and exporting data
- Data cleaning and validation
- Combining and merging datasets
- Creating summary statistics and tables
- Generating patient profiles and listings
- Creating graphs and charts for data visualization
- CDISC standards and implementation
- Quality control and validation of clinical trial data
- SAS macros and automation techniques
Note: The specific content and emphasis within each topic may vary, and it is recommended to consult the official SAS Institute materials or authorized study resources for the most accurate and up-to-date syllabus.
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A00-280
Clinical Trials Programming Using SAS 9
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QUESTION: 92
A Statistical Analysis Plan (SAP) defines the selection process for baseline records. This
instructs the programmer to choose the last non-missing analyte value prior to first study drug
administration (date/time). The DEMO data set contains the date/time of first study drug
administration for subject:
What will be the resulting baseline values, as selected per the SAP instructions?
A. Option A
B. Option B
C. Option C
D. Option D
Answer: D
QUESTION: 93
From the Statistical Analysis Plan, patients age is calculated as an integer relative to date
randomized divided by 365.25. Given the following annotated CRF:
52
Which programming code defines the patient's age?
A. age = int((birthdt-randdt)/365.25);
B. age = int((randdt-birthdt)/365.25);
C. age= int(yrdif(birthdt,randdt, "act/365.25" ));
D. age = int((today()-birthdt)/365.25);
Answer: B
QUESTION: 94
An action plan that describes what will be done in a drug study, how it will be conducted, and
why each part of the study is necessary is called:
A. a clinical trial plan
B. a protocol
C. a data management plan
D. a statistical analysis plan
Answer: B
QUESTION: 95
What is the main focus of 21 CFR Part 11?
A. electronic submission requirements
B. trial safety requirements
53
C. statistical calculation requirements
D. trial protocol requirements
Answer: A
QUESTION: 96
What is an international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects?
A. 21 CFR Part 11
B. Good Clinical Practices
C. MedDRA
D. WHODrug
Answer: B
QUESTION: 97
A patient received at least one dose of study medication prior to withdrawing from a study.
Which analysis population would always include this patient?
A. efficacy
B. intent to treat
C. per protocol
D. safety
Answer: D
QUESTION: 98
A Statistical Analysis Plan describes a clinical trial as "A 12 week, double-blind, placebo-
controlled, randomized, multi-center study." Double-blind refers to which groups in this study?
A. treatment and control group
B. investigator and subjects
C. statistician and sponsor
D. sponsor and investigator
54
Answer: B
QUESTION: 99
Given the following SAS program:
Which statement correctly identifies invalid values in the variable TRT, if only the values 'A',
B', 'C are valid?
A. if indexc(TRT, 'ABC') eq 0 then output;
B. if index(TRT, 'ABC') eq 0 then output;
C. if find(TRT, 'ABC') eq 0 then output;
D. if indexw(TRT, 'ABC') eq 0 then output;
Answer: A
55
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