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Exam Number : A00-281
Exam Name : Clinical Trials Programming Using SAS 9 Accelerated Version
Vendor Name : SASInstitute
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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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IPR evidence and Trial impact for Practitioners

For accused infringers counting on invalidity defenses that were introduced in an inter partes assessment (“IPR”) to battle willful infringement allegations in district court, the shift in IPR success rates can spell hindrance. facts of an IPR during which all asserted claims have been no longer petitioned or one of the most challenged claims had been no longer invalidated in a closing written decision can undermine willful infringement defenses. And now that Halo v. Pulse has chipped away at the excessive-bar of the Seagate goal prong in choose of a fact-intensive comparison, willfulness is greater likely to be a centerpiece of jury trials. See Halo Elecs., Inc. v. Pulse Elecs., Inc., No. 14-1513, 2016 WL 3221515 (U.S. June 13, 2016); In re Seagate Tech. LLC, 479 F.3d 1360 (Fed. Cir. 2007) (en banc). in consequence, facts concerning the strength of and reliance on IPR-introduced defenses is more likely to come into the checklist at trial. Petitioner-defendants should put together early for the chance that proof of perceived IPR screw ups will be offered to jury to stay away from being left with no admissible facts disproving willful infringement. A smartly-organized defendant can even turn the tables on the patent proprietor by using the perceived screw ups to its personal potential in entrance of the jury.


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