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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?
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?
age = int((birthdt-randdt)/365.25);
age = int((randdt-birthdt)/365.25);
age= int(yrdif(birthdt,randdt, "act/365.25" ));
age = int((today()-birthdt)/365.25);
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 clinical trial plan
a data management plan
a statistical analysis plan
What is the main focus of 21 CFR Part 11?
electronic submission requirements
trial safety requirements
statistical calculation requirements
trial protocol requirements
What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects?
21 CFR Part 11
Good Clinical Practices
A patient received at least one dose of study medication prior to withdrawing from a study. Which analysis population would always include this patient?
intent to treat
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?
treatment and control group
investigator and subjects
statistician and sponsor
sponsor and investigator
Given the following SAS program:
Which statement correctly identifies invalid values in the variable TRT, if only the values 'A', B', 'C are valid?
if indexc(TRT, 'ABC') eq 0 then output;
if index(TRT, 'ABC') eq 0 then output;
if find(TRT, 'ABC') eq 0 then output;
if indexw(TRT, 'ABC') eq 0 then output;
SASInstitute A00-280 Exam (Clinical Trials Programming Using SAS 9) Detailed Information
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A00-280 Clinical Trials Programming Using SAS 9
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Test Code : A00-280
Test Name : Clinical Trials Programming Using SAS 9
Vendor Name : SASInstitute
Q&A : 99 Real Questions
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Clinical Trials Programming Using SAS 9 education
clinical Trials Programming using SAS 9 | A00-280 Real Questions and VCE Practice Test
event is a essential component to fitting a SAS licensed expert.These components are designed to aid you put together.
These substances expect the candidate has little familiarity with SAS programming and the scientific trials trade. depending on your level of experience, you can also not require all training components. as an example, a SAS licensed Base Programmer would not require the Programming 1 and 2 classes. Please assessment the examination targets and then check which substances will complete your guidance.
* This credential is related to clinical trials programming. if your work is extra related to clinical records integration, please see the SAS scientific records Integration: necessities route.
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