Where would you store a value collected on a case report form but not defined in an SDTM domain?
A. RELREC
B. DM
C. SUPPQUAL
D. SC
Given the following data set:
Which type of clinical trials data is this?
A. Laboratory
B. Baseline
C. Medical History
D. Vital Signs
Identify the CDISC model with the following characteristics:
?XML-based content and format standard
?facilitates the archive and interchange of the metadata and data for clinical research
?provides an accurate audit trail that is 21 CRF Part II compliant
A. Analysis Data Model (ADaM)
B. Operational Data Model (ODM)
C. Study Data Tabulation Model (SDTM)
D. Trial Design Model (TDM)
Which CDISC standard is concerned with the development of simplified case report forms?
A. Clinical Data Acquisition Standards Harmonization (CDASH)
B. Operational Data Model (ODM)
C. Study Data Tabulation Model (SDTM)
D. Trial Design Model (TDM)
Define.xml is an XML-based submission of a clinical study's: A. results
B. metadata
C. data
D. protocol
A subject reports a medication started in March of 2007 but cannot recall the day number. What is the value stored in the SDTM domain CM.CMSTDTC variable?
A. 00MAR2007
B. 2007 03
C. MAR2007
D. 2007-03
Given the following data set:
Which type of clinical trials data is this?
A. Demographics
B. Laboratory
C. Medical History
D. Vital Signs
Identify the data structure with the following characteristics:
?Contains one or more records per subject, per analysis parameter, and per analysis timepoint.
?May be derived from findings, events, interventions and special-purpose SDTM domains, or other ADaM datasets.
?A record can represent an observed, derived, or imputed value required for analysis.
A. General Data Structure (GDS)
B. Basic Data Structure (BDS)
C. Subject Level Analysis Data Set (ADSL)
D. Event Level Analysis Data Set (ADAE)
This question will ask you to provide a missing option.
The following program is submitted to create a transport file for multiple data sets:
Which option will limit the files that are copied to type data?
A. intype=data
B. memtype=data
C. entrytype=data
D. include=data
The following SAS program is submitted:
Which alternative program creates an equivalent BASE_BP data set?
A. proc sort data=VS (keep=usubjid vsstresn vstestcd) out=BASE_BP (drop=vstestcd); where vstestcd in('DIABP','SYSBP'); by usubjid; run;
B. data BASE_BP; set VS (keep=usubjid vsstresn); if vstestcd in('DIABP','SYSBP'); run;
C. proc sort data=VS (keep=usubjid vsstresn vstestcd) out=BASE_BP (drop=vstestcd); by usubjid; if vstestcd in('DIABP','SYSBP'); run;
D. data BASE_BP (keep=usubjid vsstresn vstestcd); set VS (drop=vstestcd); if vstestcd in('DIABP','SYSBP'); run;
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