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| Section | Weight | Objectives |
|---|---|---|
| Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Use PROC COMPARE and log review - Validation principles |
| Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Aggregation and transposition - Derive variables and study days |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM - Clinical domain structures |
| Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Create and call macros - Debugging macros |
| Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
1. Which two variables are required in BDS ADaM data sets?
(Choose two.)
A) STUDYID
B) PARAM
C) ASEQ
D) AVAL
2. Study day is defined as DCMDATE minus RFSTDTC +1
Which statement will compute the study day correctly without producing notes for missing values in the log?
A) STUDYDAY=input(DCMDATE,yymmdd8.)-input(RFSTDTC,date9.)+1;
B) STUDYDAY=DCMDATE-RFSTDTC+1;
C) If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,yymmdd8.)- input(RFSTDTC,date9.)+1;
D) If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,date9.)- input(RFSTDTC,yymmdd8.)+1;
3. The following SAS program is submitted:
proc univariate date=work.STUDY; by VISIT; class REGION TREAT; var HBA1C GLUCOS; run; You want to store all calculated means and standard deviations in one SAS data set.
Which statement must be added to the program?
A) output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
B) ods output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
C) ods output mean=m1 m2 std=s1 s2;
D) output mean std;
4. Where would you store a value collected on a case report form but not defined in an SDTM domain?
A) SUPPQUAL
B) RELREC
C) DM
D) SC
5. Which two SDTM domains store information for the experimental design of the trial?
(Choose two.)
A) TD
B) TV
C) TA
D) TE
Solutions:
| Question # 1 Answer: A,B | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: C,D |
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