What information can be found in the SAS Dictionary tables? There are two correct answer, Please select two correct answer. A. datasets contained within a specified library B. values contained within a specified format C. variables contained within a specified dataset D. values contained within a specified variable Answer: A C

What is the primary purpose for specifying identifier variables across SDTM domains? A. To uniquely reference each record B. To satisfy regulatory conditions C. To include the appropriate subject information D. To include the appropriate study information Answer: A

When writing a validation program using independent programming, which two actions conform to good programming practices? (Choose two.) A. Ensure the production program has been run prior to compare. B. Delete subjects from the production side that are causing differences with the validation data set. C. Copy statistical code directly from the SAP. D. Copy statistical code directly from the production program. Answer: A C

What is the key to ensuring traceability across CDISC data sets and modes? A. Including STDM variables used to derive ADaM variables in the ADaM data set. B. Creating a map for each variable to all of its related predecessors. C. Establishing a clear path between an element and all of its immediate predecessors. D. Establishing a clear path between an element and all of its immediate successors. Answer: A

You have been asked to import an Excel spreadsheet. What will lead to substantial differences between the original Excel spreadsheet and the resulting SAS data set? A. the number of rows to be read from the Excel file B. the number of columns to be read from the Excel file C. multiple value types within a single column D. multiple value types within a single row Answer: C

Which of these tasks is NOT required for a validating programmer to state that an output has been independently validated using double programming once a PROC COMPARE has been run and shows the output electronically validates? A. The Statistical Analysis Plan has been approved and signed off by the sponsor. B. The output is using the correct title specified in the Statistical Analysis Plan. C. Counts displayed in the columns are coherent. D. The output is correctly paginated. Answer: A

Which statement describes an aspect of all Phase II clinical trials? A. randomized controlled multicenter trials on large patient groups B. designed to assess the pharmacovigilance, pharmacokinetics, and pharmacodynamics of a drug C. in vitro and in vivo experiments using wide-ranging doses of the drug D. designed to assess how well the drug works and further assess safety Answer: D

What is the primary purpose of programming validation? A. Ensure that the output from both the original program and the validation program match. B. Efficiently ensure any logic errors are discovered early in the programming process. C. Justify the means used to accomplish the outcome of a program and ensure its accurate representation of the original data. D. Document all specifications pertaining to programmed output and ensure all were reviewed during the programming process. Answer: C

Which two features are captured by the events general observation class of SDTM? (Choose two.) A. Investigational or therapeutic treatments B. Planned protocol milestones C. Planned evaluations D. Subject characteristics Answer: B C

What is the main focus of Good Clinical Practices (GCP)? A. harmonized data collection B. standard analysis practices C. protection of subjects D. standard monitoring practices Answer: C