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Exam Number : A00-281
Exam Name : Clinical Trials Programming Using SAS 9 Accelerated Version
Vendor Name : SASInstitute
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Exam ID : A00-281
Exam Title : Clinical Trials Programming Using SAS 9 - Accelerated Version
Questions : 70 to 75
Pass Marks : 70%
Duration : 2 hours
Exam Type : Multiple Choice

Clinical Trials Process
Describe the clinical research process (phases, key roles, key organizations).
Interpret a Statistical Analysis Plan.
Derive programming requirements from an SAP and an annotated Case Report Form.
Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices).
Clinical Trials Data Structures
Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
Identify key CDISC principals and terms.
Describe the structure and purpose of the CDISC SDTM data model.
Describe the structure and purpose of the CDISC ADaM data model.
Describe the contents and purpose of define.xml.
Import and Export Clinical Trials Data
Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).
Manage Clinical Trials Data
Access DICTIONARY Tables using the SQL procedure.
Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).
Transform Clinical Trials Data
Apply categorization and windowing techniques to clinical trials data.
Transpose SAS data sets.
Apply 'observation carry forward' techniques to clinical trials data (LOCF, BOCF, WOCF).
Calculate 'change from baseline' results.
Obtain counts of events in clinical trials.
Apply Statistical Procedures for Clinical Trials
Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).
Use PROC FREQ to obtain p-values for categorical data (2x2 and NxP test for association).
Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests).
Create output data sets from statistical procedures.
Macro Programming for Clinical Trials
Create and use user-defined and automatic macro variables.
Automate programs by defining and calling macros.
Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).
Report Clinical Trials Results
Use PROC REPORT to produce tables and listings for clinical trials reports.
Use ODS and global statements to produce and augment clinical trials reports.
Validate Clinical Trial Data Reporting
Explain the principles of programming validation in the clinical trial industry.
Utilize the log file to validate clinical trial data reporting.
Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
Identify and Resolve data, syntax and logic errors.



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summary and creationIntroduction

long-term indicators regularly linked to COVID-19 (publish-COVID circumstances or lengthy COVID) are an emerging public fitness subject that is not neatly understood. occurrence of publish-COVID situations has been pronounced among folks who have had COVID-19 (latitude = 5%–eighty%), with modifications perhaps related to diverse study populations, case definitions, and facts sources.[1] Few reports of post-COVID situations have comparisons with the general population of adults with bad check results for SARS-CoV-2, the virus that factors COVID-19, limiting capacity to examine background symptom occurrence.[1] CDC used a nonprobability-based cyber web panel dependent with the aid of Porter Novelli Public services* to manage a survey to a nationwide demo of U.S. adults aged ≥18 years to compare the occurrence of lengthy-term indicators (those lasting >four weeks in view that onset) amongst people who self-pronounced ever receiving a positive SARS-CoV-2 examine outcome with the occurrence of identical signs among people who suggested always receiving a negative verify effect. The weighted incidence of ever trying out effective for SARS-CoV-2 changed into 22.2% (ninety five% confidence interval [CI] = 20.6%–23.eight%). about two thirds of respondents who had bought a good check outcome skilled lengthy-time period indicators commonly linked to SARS-CoV-2 an infection. in comparison with respondents who got a negative look at various result, those that obtained a favorable look at various result suggested a greatly larger prevalence of any lengthy-time period symptom (sixty five.9% versus 42.9%), fatigue (22.5% versus 12.0%), exchange in sense of smell or style (17.three% versus 1.7%), shortness of breath (15.5% versus 5.2%), cough (14.5% versus 4.9%), headache (13.8% versus 9.9%), and persistence (>four weeks) of at least one at the beginning taking place symptom (seventy six.2% versus 69.6%). compared with respondents who acquired a bad check effect, a larger percentage of people who acquired a good look at various influence reported believing that receiving a COVID-19 vaccine made their long-time period indicators greater (28.7% versus 15.7%). Efforts to handle put up-COVID conditions should encompass helping health care authorities respect essentially the most normal submit-COVID conditions and optimize look after patients with persisting symptoms, together with messaging on potential merits of COVID-19 vaccination.

all the way through April 9–23, 2021, Porter Novelli Public capabilities and ENGINE Insights† performed a nonprobability-primarily based internet panel survey amongst 6,021 noninstitutionalized U.S. adults aged ≥18 years by means of the Lucid platform.§ Quota sampling and statistical weighting were used to align the demo with U.S. inhabitants distributions through sex, age neighborhood, U.S. Census place, race and ethnicity, and education. Respondents self-mentioned ever having got a favorable SARS-CoV-2 examine outcomes (698), at all times receiving a bad look at various outcome (2,437), or in no way having been validated for SARS-CoV-2 (2,750); handiest deidentified respondents who mentioned having acquired either a favorable or a bad look at various outcomes had been covered in this evaluation. Respondents who bought a poor test had been selected to establish the prevalence of put up-COVID symptoms in a population that didn't get hold of a COVID-19 prognosis. assessment of initial indicators, together with signs that might have commenced earlier than testing,¶ was performed through asking respondents who got a good examine influence, "throughout the month of your first nice COVID-19 check, which, if any, of the following indicators did you event?" followed with the aid of a listing of symptoms. Respondents who acquired a poor look at various outcome were requested, "considering that January 2020, which, if any, of right here signs have you skilled?" lengthy-term signs were assessed through asking those that obtained a good look at various outcome, "Which, if any, of your indicators lasted longer than four weeks after your first tremendous COVID-19 check?"; those that acquired a terrible check result had been asked, "Which, if any, of your indicators lasted longer than 4 weeks given that you first skilled the signs?" Respondents had been asked about health care use and receipt of ≥1 dose of a COVID-19 vaccine. Vaccine impact related to symptoms changed into assessed via asking respondents** how receiving a COVID-19 vaccination affected their long-term symptoms (these lasting ≥four weeks).††

aspect estimates and ninety five% CIs were calculated, ordinary and by using demographic qualities (age neighborhood, intercourse, marital status, optimum educational attainment, employment, 2020 household salary, race and ethnicity, U.S. Census location, and group classification§§). Comparisons of demographic features and symptoms had been performed the use of chi-rectangular tests; p-values <0.05 have been regarded statistically enormous. All analyses had been performed using SAS (version 9.4; SAS Institute) and had been weighted with the aid of intercourse, age community, location, race and ethnicity, and training. This pastime was reviewed via CDC and was performed per relevant federal legislation and CDC coverage.¶¶

among the three,135 adults who pronounced having been confirmed for SARS-CoV-2 considering that January 2020, the weighted prevalence of ever receiving a positive look at various result changed into 22.2% (desk 1). in comparison with respondents who acquired a poor check influence (2,437), folks that got a good check influence (698) have been younger (median age = 39.3 years versus 45.three years), and an improved share were working (70.5% versus 61.6%), had bigger household salary (50.8% versus 43.9% made ≥$60,000), and lived in an city group (forty three.eight% versus 37.6%).

standard, 603 (86.5%) respondents who got a good test effect and 1,526 (61.7%) of people who got a poor test outcomes suggested any preliminary indicators. among respondents who stated an initial symptom, more respondents who acquired a good test result (seventy six.2%) than people that acquired a bad test outcomes (69.6%) reported persistence (>4 weeks) of at the least one symptom (p = 0.005) (Supplementary table, https://stacks.cdc.gov/view/cdc/108815). Hair loss (fifty eight.three%), cognitive dysfunction*** (fifty five.5%), shortness of breath (52.8%), and postexertional malaise††† (49.6%) persevered for ≥50% of those that acquired a positive verify outcome and firstly stated these signs; different symptoms, reminiscent of fatigue (forty eight.4%), change in scent or style (forty six.4%), cough (36.2%), and headache (31.1%) persevered for <50%.

a more robust share of respondents who acquired a favorable check effect than those that bought a terrible look at various outcomes pronounced any long-term symptoms (sixty five.9% versus forty two.9%; p<0.05) (desk 2). the most normal symptoms have been fatigue (22.5% versus 12.0%), alternate in odor or taste (17.three% versus 1.7%), shortness of breath (15.5% versus 5.2%), cough (14.5% versus four.9%), and headache (13.eight% versus 9.9%). amongst only respondents who suggested any long-time period signs, essentially the most normal indicators amongst people who bought a good verify effect in comparison with those that received a bad look at various outcome have been fatigue (34.2% versus 28.0%), exchange in scent or style (26.2% versus 3.9%), shortness of breath (23.6% versus 12.1%), cough (22.0% versus eleven.5%), and headache (20.9% versus 23.0%) (all p<0.05 other than headache).

a bigger proportion of respondents who obtained a positive look at various outcome than people that acquired a negative check outcome reported seeing a surgeon (fifty four.1% versus forty two.5%; p<0.001) or going to pressing or emergency care (19.5% versus 14.0%, p = 0.008) for signs once they first passed off; prices of hospitalization had been similar (10.four% versus 9.three%) (desk three). amongst these reporting any long-time period signs, fewer respondents who acquired a good verify outcome than those that acquired a terrible check result suggested seeing a general practitioner for long-term indicators as a minimum once (24.7% versus 35.8%) or greater than once (17.6% versus 27.9%).

Fewer respondents who acquired a favorable examine influence than those that acquired a bad check result reported receiving ≥1 dose of a COVID-19 vaccine (28.3% versus 39.4%). among those that ever experienced any lengthy-time period indicators, greater respondents who received a favorable test influence than those that got a bad verify outcomes reported that having long-time period symptoms motivated them to receive or consider receiving a COVID-19 vaccine (eleven.0% versus 7.0%) and believed that receiving the vaccine made their long-term indicators stronger (28.7% versus 15.7%; p = 0.023), or that their indicators were long past before receiving the vaccine (28.four% versus 13.1%). a similar percentage of respondents who got a favorable test result (16.1%) and those that got a terrible test influence (11.2%) suggested that receiving the vaccine made their long-time period symptoms worse (p = 0.271), whereas 26.four% of respondents who received a positive check effect and 59.2% of people that got a terrible check influence believed that receiving a vaccine didn't have an effect on their indicators (p<0.001).


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