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Format | A00-281 Course Contents | A00-281 Course Outline | A00-281 test
Syllabus | A00-281 test
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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Experimental stories and small medical trials have suggested that treatment with intranasal oxytocin might also reduce social impairment in persons with autism spectrum ailment. Oxytocin has been administered in scientific apply to many children with autism spectrum disorder.
We performed a 24-week, placebo-managed phase 2 trial of intranasal oxytocin remedy in infants and teens 3 to 17 years of age with autism spectrum sickness. individuals had been randomly assigned in a 1:1 ratio, with stratification based on age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a complete goal dose of 48 international devices every day. The basic effect was the least-squares suggest change from baseline on the Aberrant conduct guidelines modified Social Withdrawal subscale (ABC-mSW), which contains 13 objects (ratings range from 0 to 39, with bigger ratings indicating much less social interaction). Secondary consequences covered two additional measures of social feature and an abbreviated measure of IQ.
Of the 355 babies and adolescents who underwent screening, 290 were enrolled. a complete of 146 participants had been assigned to the oxytocin group and one hundred forty four to the placebo community; 139 and 138 participants, respectively, achieved each the baseline and as a minimum one postbaseline ABC-mSW assessments and have been included within the modified intention-to-deal with analyses. The least-squares mean trade from baseline in the ABC-mSW ranking (fundamental outcomes) was −3.7 within the oxytocin neighborhood and −3.5 in the placebo neighborhood (least-squares suggest change, −0.2; 95% self assurance interval, −1.5 to 1.0; P=0.sixty one). Secondary effects often didn't vary between the trial agencies. The incidence and severity of adversarial pursuits have been identical in the two agencies.
This placebo-controlled trial of intranasal oxytocin therapy in babies and teens with autism spectrum ailment showed no massive between-neighborhood modifications in the least-squares imply alternate from baseline on measures of social or cognitive functioning over a duration of 24 weeks. (Funded by means of the country wide Institute of infant fitness and Human construction; SOARS-B ClinicalTrials.gov quantity, NCT01944046.)
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