SASInstitute SAS Foundation A00-280 Questions & Answers

• Question 1:

  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;

  Correct Answer: A

• Question 2:

  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

  Correct Answer: B

• Question 3:

  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

  Correct Answer: D

• Question 4:

  What is the main focus of 21 CFR Part 11?

  A. electronic submission requirements

  B. trial safety requirements

  C. statistical calculation requirements

  D. trial protocol requirements

  Correct Answer: A

• Question 5:

  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

  Correct Answer: B

• Question 6:

  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

  Correct Answer: B

• Question 7:

  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:

  

  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);

  Correct Answer: B

• Question 8:

  Which statement correctly describes an aspect of a Phase II clinical trial?

  A. randomized controlled multicenter trials on large patient groups

  B. designed to assess the pharmacovigilance, pharmacokinetics, and pharmacodynamics of a drug

  C. in vitro and in vivo experiments using wide-ranging doses of the drug

  D. designed to assess how well the drug works

  Correct Answer: D

• Question 9:

  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

  Correct Answer: D

• Question 10:

  The purpose of the ADaM model is to provide a framework that:

  A. enables the tabulation of the raw source data

  B. enables the creation of study patient profiles

  C. enables the statistical analysis of the data

  D. can be used to generate the CDISC ODM

  Correct Answer: C