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SASInstitute A00-281 : Clinical Trials Programming Using SAS 9 Accelerated Version Exam
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A00-281 test
Format | A00-281 Course Contents | A00-281 Course Outline | A00-281 test
Syllabus | A00-281 test
Objectives
Exam ID : A00-281
Exam Title : Clinical Trials Programming Using SAS 9 - Accelerated Version
Questions : 70 to 75
Pass Marks : 70%
Duration : 2 hours
Exam Type : Multiple Choice
Clinical Trials Process
Describe the clinical research process (phases, key roles, key organizations).
Interpret a Statistical Analysis Plan.
Derive programming requirements from an SAP and an annotated Case Report Form.
Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices).
Clinical Trials Data Structures
Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
Identify key CDISC principals and terms.
Describe the structure and purpose of the CDISC SDTM data model.
Describe the structure and purpose of the CDISC ADaM data model.
Describe the contents and purpose of define.xml.
Import and Export Clinical Trials Data
Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).
Manage Clinical Trials Data
Access DICTIONARY Tables using the SQL procedure.
Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).
Transform Clinical Trials Data
Apply categorization and windowing techniques to clinical trials data.
Transpose SAS data sets.
Apply 'observation carry forward' techniques to clinical trials data (LOCF, BOCF, WOCF).
Calculate 'change from baseline' results.
Obtain counts of events in clinical trials.
Apply Statistical Procedures for Clinical Trials
Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).
Use PROC FREQ to obtain p-values for categorical data (2x2 and NxP test for association).
Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests).
Create output data sets from statistical procedures.
Macro Programming for Clinical Trials
Create and use user-defined and automatic macro variables.
Automate programs by defining and calling macros.
Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).
Report Clinical Trials Results
Use PROC REPORT to produce tables and listings for clinical trials reports.
Use ODS and global statements to produce and augment clinical trials reports.
Validate Clinical Trial Data Reporting
Explain the principles of programming validation in the clinical trial industry.
Utilize the log file to validate clinical trial data reporting.
Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
Identify and Resolve data, syntax and logic errors.
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If at the start you don’t be triumphant, try once more, the saying goes. And that appears to be JP Morgan Chase’s approach to decreasing worker healthcare fees. Months after disbanding Have fitness, its joint venture with Berkshire Hathaway and Amazon, the economic company is launching its own healthcare business unit: Morgan fitness. it's going to invest as much as $250 million and enter into partnerships concerning agency-subsidized healthcare. Haven showed that even the good company juggernauts may be waylaid by means of the complexities of the healthcare system, so there’s skepticism as as to if this new approach will work.
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a brand new look at discovered decrease survival prices for lung cancer patients aged 66-89 handled with immunotherapy, versus the clinical trial information. This distinction is vital as a result of over the last few years, immunotherapy has develop into a key part of cancer treatment, and drugs during this class can pull in billions of bucks in revenue each year. The main purpose is medical trials have proven these cures can result in vastly better results in comparison to chemotherapy with fewer aspect effects. although, the consequences of the analyze indicate it’s essential to encompass extra age companies in scientific trials, for the reason that the samples skewed younger than the actual-world inhabitants the usage of the medication. study more right here.
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Why Vaccine IP insurance policy Is in reality important
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The frequent aid for waiving patent insurance policy for Covid-19 vaccines is symptomatic of a bigger problem, argues contributor Rita Numerof. That’s a scarcity of understanding of the nature of drug development and why IP insurance policy is so vital. examine extra here.
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