SAS Certified Clinical Trials Programming Using SAS 9 (A00-280)

Exam Code: A00-280

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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:

? Combine SAS data sets.

? Efficiently import and subset SAS data sets.

? Access data in an Excel workbook (LIBNAME and PROC IMPORT/EXPORT).

? Create temporary and permanent SAS data sets.

? Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

Manage Clinical Trials Data:

? Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ).

? Access DICTIONARY Tables using the SQL procedure.

? Sort observations in a SAS data set.

? Create and modify variable attributes using options and statements in the DATA step.

? Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

?Pass rate for this exam is 70%, that means you should answer 67 questions correctly out of 95. Please note we provide you total 99 Questions & Answers for your perusal?.

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