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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?

1. Option A

2. Option B

3. Option C

4. 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:

Which programming code defines the patient's age?

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

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

3. age= int(yrdif(birthdt,randdt, "act/365.25" ));

4. 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:

1. a clinical trial plan

2. a protocol

3. a data management plan

4. a statistical analysis plan

Answer: B

QUESTION: 95

What is the main focus of 21 CFR Part 11?

1. electronic submission requirements

2. trial safety requirements

   
   

3. statistical calculation requirements

4. 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?

1. 21 CFR Part 11

2. Good Clinical Practices

3. MedDRA

4. 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?

1. efficacy

2. intent to treat

3. per protocol

4. 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?

1. treatment and control group

2. investigator and subjects

3. statistician and sponsor

4. sponsor and investigator

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?

1. if indexc(TRT, 'ABC') eq 0 then output;

2. if index(TRT, 'ABC') eq 0 then output;

3. if find(TRT, 'ABC') eq 0 then output;

4. if indexw(TRT, 'ABC') eq 0 then output;

Answer: A