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;

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

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

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

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

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

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);

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

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

Question 10

CORRECT TEXT
Which CDISC filename contains the following items?
• Variable attributes
• Controlled terminology
• Computational methods
Enter your answer in the space below (Case is ignored. Do not add leading or trailing spaces to your
answer.).

Question 11

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

Question 12

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

Question 13

Given the following data set:

Which type of clinical trials data is this?

• A. Laboratory
• B. Baseline
• C. Medical History
• D. Vital Signs

Question 14

Which CDISC standard is concerned with the development of simplified case report forms?

• A. Clinical Data Acquisition Standards Harmonization (CDASH)
• B. Operational Data Model (ODM)
• C. Study Data Tabulation Model (SDTM)
• D. Trial Design Model (TDM)

Question 15

Identify the CDISC model with the following characteristics:
• XML-based content and format standard
• facilitates the archive and interchange of the metadata and data for clinical research
• provides an accurate audit trail that is 21 CRF Part II compliant

• A. Analysis Data Model (ADaM)
• B. Operational Data Model (ODM)
• C. Study Data Tabulation Model (SDTM)
• D. Trial Design Model (TDM)