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Exam Review

Key Facts: SAS Clinical Trials Programming Exam

60-70

Exam Questions

SAS A00-282 credential page

110 min

Exam Duration

SAS A00-282 credential page

68%

Passing Score

SAS A00-282 credential page

$180

Exam Fee (USD)

SAS global exam pricing

A00-282

Exam Code

SAS certification registry

20%

Validation Domain Weight

SAS A00-282 exam content guide

9

Domain Areas

SAS A00-282 exam content guide

The A00-282 exam has 60-70 multiple-choice and short-answer questions in 110 minutes at $180 USD with a 68% passing score. SAS upgraded this credential from Specialist to Professional. Candidates must hold the SAS Base Programming Specialist or Advanced Programming Professional credential plus six months of clinical trials experience. Nine domains: Clinical Trials Process (5%), Data Structures (10%), Regulatory Submissions (5%), Managing Data (5%), Transforming/Summarizing (15%), Applying Statistical Procedures (15%), Macro Programming (15%), Reporting Results (10%), and Validating Data Reporting (20%).

Sample SAS Clinical Trials Programming Practice Questions

Try these sample questions to review concepts for the SAS Clinical Trials Programming exam. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1What does the acronym CDISC stand for in clinical trials data standards?
A.Clinical Data Interchange Standards Consortium
B.Centralized Drug Information Standards Committee
C.Clinical Database Integration Standards Council
D.Computerized Data Inspection and Submission Coalition
Explanation: CDISC stands for Clinical Data Interchange Standards Consortium, a global non-profit organization that develops data standards (SDTM, ADaM, SEND, Define-XML) used in regulatory submissions to FDA, PMDA, and other agencies.
2Which CDISC standard defines the structure of submission datasets describing observed clinical trial data?
A.ADaM
B.SDTM
C.SEND
D.ODM
Explanation: SDTM (Study Data Tabulation Model) defines the standard structure for submission datasets that contain observed/collected clinical trial data, organized into domains such as DM, AE, CM, EX, LB, and VS.
3Which CDISC model is specifically designed to support statistical analysis of clinical trial results?
A.SDTM
B.SEND
C.ADaM
D.CDASH
Explanation: ADaM (Analysis Data Model) is built from SDTM datasets and is structured to support statistical analyses for FDA submissions. ADaM datasets are analysis-ready and traceable back to SDTM.
4What is the purpose of the USUBJID variable in SDTM and ADaM datasets?
A.It stores the subject's date of birth
B.It is a unique identifier for a subject across all studies in a submission
C.It identifies the visit number
D.It identifies the treatment arm
Explanation: USUBJID is the Unique Subject Identifier and must be unique across all studies within a submission. It is typically constructed by concatenating STUDYID, SITEID, and SUBJID to ensure global uniqueness.
5Which SDTM domain holds Demographics data for trial subjects?
A.DS
B.DM
C.MH
D.TS
Explanation: DM is the Demographics domain in SDTM and is a Special Purpose domain. It contains one record per subject with variables such as USUBJID, AGE, SEX, RACE, ETHNIC, ARM, and COUNTRY.
6Which SDTM domain captures Adverse Events?
A.AE
B.CE
C.MH
D.DS
Explanation: AE is the Adverse Events domain. Required variables include AETERM (reported term), AEDECOD (dictionary-derived term), AESEV (severity), AESER (serious flag), AESTDTC (start date), and AEENDTC (end date).
7In the SDTM AE domain, which variable identifies whether an adverse event was serious?
A.AESEV
B.AESER
C.AEREL
D.AEACN
Explanation: AESER is the Serious Event flag (Y/N) and indicates regulatory seriousness as defined by ICH E2A criteria (death, life-threatening, hospitalization, disability, congenital anomaly, or other medically important event).
8Which date format is required for ISO 8601 character date variables (--DTC) in SDTM?
A.MM/DD/YYYY
B.DDMONYYYY
C.YYYY-MM-DDThh:mm:ss
D.YYYYMMDD
Explanation: SDTM --DTC variables use ISO 8601 extended format YYYY-MM-DDThh:mm:ss. Partial dates are allowed, e.g., 2026-05 or 2026-05-09T14:30. The format is character, not numeric.
9What does the --SEQ variable represent in SDTM domains?
A.The sequence of dosing within a visit
B.A unique sequence number for each record within USUBJID and DOMAIN
C.The protocol version sequence
D.The order of laboratory tests collected
Explanation: --SEQ (e.g., AESEQ, CMSEQ, LBSEQ) provides a unique sequence number for each record within a subject (USUBJID) within a domain. It is required for traceability and to uniquely identify records.
10Which SDTM domain stores Concomitant Medications data?
A.EX
B.CM
C.EC
D.MH
Explanation: CM is the Concomitant Medications domain. It captures non-study medications taken by the subject. Key variables include CMTRT (reported name), CMDECOD (WHO-DD coded name), CMINDC (indication), CMSTDTC, and CMENDTC.

About the SAS Clinical Trials Programming Exam

The SAS Certified Professional: Clinical Trials Programming Using SAS 9.4 (A00-282) credential validates the ability to apply CDISC SDTM and ADaM standards, transform and summarize clinical trials data, run statistical procedures, build clinical macro programs, produce TLFs for regulatory submissions, and validate the resulting reporting using SAS 9.4.

Exam sponsor: SAS / Pearson VUE. The requirements and fees below concern the certification or admission exam, separate from our free practice resources.

Questions

65 questions

Time Limit

1 hour 50 minutes

Passing Score

68%

Exam / Certification Fees

$180 USD

Exam sponsor website

Reported exam pass rate: Not published. Exam sponsor website

Fees, eligibility, and exam policies can change. Confirm them with the exam sponsor before applying or paying.

Our practice resources: topics covered

We aim to reflect publicly available exam outlines and topic information in our study resources. Coverage, format, and difficulty may differ from the actual exam, and we cannot guarantee that every detail is accurate or current. Confirm exam requirements, fees, and policies with the official exam sponsor.

5%

Clinical Trials Process

ICH GCP (E6), trial phases, DMC/DSMB, IRB/Ethics, informed consent, MedDRA AE coding, WHO-DD medication coding, source data verification.

10%

Clinical Trials Data Structures

CDISC SDTM domains (DM, AE, CM, EX, LB, VS, DS, MH, TS, TA, TE, TI), ADaM (ADSL, ADAE, ADTTE, ADLB, ADVS), BDS vs OCCDS, USUBJID, --SEQ, --DTC ISO 8601, --DY/RFSTDTC, ARM vs ACTARM, SUPPxx.

5%

Regulatory Submissions

FDA eCTD, SAS XPORT v5 (.xpt), Define-XML 2.x with value-level metadata and methods, cSDRG/ADRG, CDISC Controlled Terminology (NCI EVS), 21 CFR Part 11 audit trails, SEND for nonclinical.

5%

Managing Clinical Trials Data

MERGE BY USUBJID, PROC SQL joins, INPUT/PUT for ISO 8601 dates (YYMMDD10., IS8601DA.), partial-date imputation, study day rules (no Day 0), age via YRDIF, SUM() for missing-value safety.

15%

Transforming and Summarizing Clinical Trials Data

PROC TRANSPOSE long/wide reshaping, PROC FREQ cross-tabs, PROC SQL COUNT(DISTINCT USUBJID), BMI = WEIGHT/(HEIGHT/100)**2, change/percent-change derivations, AVISIT windowing, LOCF.

15%

Applying Statistical Procedures

PROC TTEST two-sample, PROC GLM/MIXED ANCOVA and MMRM (REPEATED with TYPE=UN), PROC LIFETEST (K-M, log-rank), PROC PHREG (Cox HR), PROC LOGISTIC, ICH E9(R1) estimands.

15%

Macro Programming for Clinical Trials

%MACRO/%MEND, keyword parameters with defaults, %LOCAL/%GLOBAL scope, %EVAL vs %SYSEVALF, %STR/%NRSTR/%QUOTE quoting, SYSAUTOS autocall, %INCLUDE, MPRINT/MLOGIC/SYMBOLGEN, CALL SYMPUTX.

10%

Reporting Clinical Trials Results

PROC REPORT (DEFINE GROUP/ACROSS/ANALYSIS), PROC TABULATE for hierarchical summaries, ODS RTF/PDF/TAGSETS.RTF, K-M plots via PROC LIFETEST PLOTS=SURVIVAL, AE summary tables by SOC/PT and arm.

20%

Validating Clinical Trial Data Reporting

Independent double programming, PROC COMPARE plus &SYSINFO bitmap, Pinnacle 21 CDISC conformance, SDTM-to-ADaM traceability (SRCDOM/SRCSEQ/SRCVAR), OPTIONS MERGENOBY=ERROR, SAP as source of truth.

Preparing for the SAS Clinical Trials Programming Exam

What You Need to Know

  • Passing score: 68%
  • Exam length: 65 questions
  • Time limit: 1 hour 50 minutes
  • Exam / certification fees: $180 USD Official sources

Using Our Practice Resources

  • Work through all 100 available questions
  • Review every answer and explanation
  • Track weak areas and revisit them
  • Use our AI tutor for tough concepts

SAS Clinical Trials Programming: Suggested Study Strategy

1Treat the 20% Validation domain as the highest-leverage study area: master PROC COMPARE, &SYSINFO bitmap, Pinnacle 21, and double-programming workflows.
2Memorize SDTM key conventions: ISO 8601 in --DTC, study Day 1 = RFSTDTC (no Day 0), USUBJID uniqueness across studies, and --SEQ uniqueness within USUBJID/DOMAIN.
3Drill ADaM derivations until automatic: BASE selection via ABLFL='Y', CHG = AVAL - BASE, PCHG = 100*(CHG/BASE), TRTEMFL, ANL01FL, and ADTTE CNSR convention (0=event, 1=censored).
4Practice macro debugging with OPTIONS MPRINT MLOGIC SYMBOLGEN; build at least one parameterized clinical macro using keyword parameters and %LOCAL scoping.
5Code real TLFs end-to-end: AE incidence by SOC/PT/arm using ADSL denominator and ADAE numerator with COUNT(DISTINCT USUBJID), then render with PROC REPORT and ODS RTF.
6For statistics, focus on PROC LIFETEST + PROC PHREG for time-to-event, PROC MIXED MMRM for longitudinal data, and PROC GLM ANCOVA for change-from-baseline.

Frequently Asked Questions

How many questions are on the SAS A00-282 Clinical Trials Programming exam?

The A00-282 exam has 60-70 multiple-choice and short-answer (performance-based) questions to be completed in 1 hour 50 minutes (110 minutes).

What score do I need to pass A00-282?

The passing score is 68% on a percentage scale. Performance is measured across all nine domains, with the 20%-weighted Validation of Clinical Trial Data Reporting domain being the most heavily weighted.

How much does the SAS Clinical Trials Programming exam cost?

The exam fee is $180 USD worldwide through Pearson VUE. SAS occasionally offers academic discounts for students and educators.

What are the prerequisites for this exam?

Candidates must hold either the SAS Base Programming Specialist or Advanced Programming Professional credential, complete recommended training (or equivalent experience), and have at least six months of experience as a clinical trials programmer using SAS software.

Is this the same as the older SAS Clinical Trials Programming Specialist exam?

SAS upgraded the credential from Specialist to Professional. The current exam (A00-282) covers nine domains including a heavily weighted 20% validation domain, reflecting the broader scope expected of a Professional-level credential.

Which CDISC standards are tested?

The exam tests SDTM (domains DM, AE, CM, EX, LB, VS, DS, MH, TS, TA, TE, TI), ADaM (ADSL, ADAE, ADTTE, ADLB, ADVS with BDS and OCCDS structures), Define-XML 2.x, CDISC Controlled Terminology, and CDASH for collection. SEND is referenced for nonclinical context.