Given the following data set (AE):

Data will be reported by onset week. Day 1?
7 is Week 1, Day 8 ?14 is Week 2. Events beyond Day 14 are assigned Week 3 and will be reported as Follow-up events.
Which statements properly assign WEEK to each event?

• A.select; when (day > 0) week = 1; when (day > 7) week = 2; otherwise week = 3; end;
• B.select; when (day > 14) week = 3; when (day > 7) week = 2; otherwise week = 1; end;
• C.if day > 0 then week = 1; else if day > 7 then week = 2; else if day > 14 then week = 3;
• D.if day > 14 then week = 3; else if day > 7 then week = 2; else if day > 0 then week = 1;

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Which CDISC standard is concerned with the development of simplified case report forms?

• A.Trial Design Model (TDM)
• B.Operational Data Model (ODM)
• C.Study Data Tabulation Model (SDTM)
• D.Clinical Data Acquisition Standards Harmonization (CDASH)

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A subject visit data set (Visits) includes variables for subject ID (SubjID) and visit date (VisitDT).
Which DATA step creates a data set with one record per subject and creates a variable (Visits) that computes the total number of visits for that subject?

• A.proc sort data=Visits out=SortVisits;
  by SubjID VisitDT;
  run;
  data VisitCount;
  set SortVisits;
  by SubjID VisitDT;
  if first.SubjID then Visits=0;
  if last.SubjID then output;
  Visits+1;
  keep SubjID Visits;
  run;
• B.proc sort data=Visits out=SortVisits;
  by SubjID VisitDT;
  run;
  data VisitCount;
  set SortVisits;
  by SubjID VisitDT;
  if first.SubjID then Visits=0;
  else if last.SubjID then output;
  Visits+1;
  keep SubjID Visits;
  run;
• C.proc sort data=Visits out=SortVisits;
  by SubjID VisitDT;
  run;
  data VisitCount;
  set SortVisits;
  by SubjID VisitDT;
  if first.SubjID then Visits=0;
  else if last.SubjID then output;
  else Visits+1;
  keep SubjID Visits;
  run;
• D.proc sort data=Visits out=SortVisits;
  by SubjID;
  run;
  data VisitCount;
  set SortVisits;
  by SubjID;
  if first.SubjID then Visits=0;
  Visits+1;
  if last.SubjID then output;
  keep SubjID Visits;
  run;

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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.Subject Level Analysis Data Set (ADSL)
• B.Basic Data Structure (BDS)
• C.General Data Structure (GDS)
• D.Event Level Analysis Data Set (ADAE)

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Which clause allows macro variable creation on a select statement in PROC SQL?

• A.AS
• B.SYMPUT
• C.INTO
• D.%MACRO

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