SAS Institute A00-280 Online Practice Questions and Exam Preparation

SAS Institute A00-280 Online 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;
  A. if indexc(TRT, 'ABC') eq 0 then output;

• 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
  B. investigator and subjects

• 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
  D. safety

• Question 4:

  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
  B. Good Clinical Practices

• Question 5:

  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
  A. electronic submission requirements

• 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
  B. a protocol

• 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);
  B. age = int((randdt-birthdt)/365.25);

• Question 8:

  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
  D. Option D

• Question 9:

  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
  D. designed to assess how well the drug works

• Question 10:

  Where would you store a value collected on a case report form but not defined in an SDTM domain?

  A. RELREC
  B. DM
  C. SUPPQUAL
  D. SC
  C. SUPPQUAL