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A00-281 – Clinical Trials Programming Using SAS 9 Accelerated Version Real Exam Questions and Answers

Clinical Trials Programming Using SAS 9 Accelerated Version

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Test Name : Clinical Trials Programming Using SAS 9 Accelerated Version
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A00-281 exam Format | A00-281 Course Contents | A00-281 Course Outline | A00-281 exam Syllabus | A00-281 exam Objectives


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 (2×2 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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bought von Willebrand Syndrome in Aortic Stenosis | A00-281 PDF Questions and exam Questions

incidence of Bleeding table 2. desk 2. Hemorrhagic issues That came about within the patients.

among the many 42 sufferers with severe aortic stenosis, eleven had episodes of bleeding within the six months before surgery. In two, the bleeding episode happened right through oral anticoagulant medicine and was no longer taken under consideration in further analysis. therefore, 9 of forty two sufferers (21.4 percent) had as a minimum one episode of bleeding, most generally dermis or mucosal bleeding (table 2). among these, one patient had a background of main bleeding (epistaxis) that obligatory transfusion. among the many eight patients with average aortic stenosis, two had a historical past of hemorrhagic syndrome, both whereas receiving antiplatelet agents. There became no difference between sufferers with O and non-O blood kinds with respect to the incidence of bleeding episodes.Base-Line Biologic records

The closure time determined by way of the platelet-characteristic analyzer (which measures platelet feature below situations of excessive shear stress) was extended in ninety two percent of the patients with extreme aortic stenosis and in 50 p.c of these with reasonable aortic stenosis. The ratio of collagen-binding pastime to antigen and the percent of optimum-molecular-weight multimers have been diminished in 67 and 79 % of the patients with extreme aortic stenosis and in 25 and seventy five % of the sufferers with average aortic stenosis, respectively. All sufferers with prolonged closure time based on the platelet-feature analyzer had reduced percentages of highest-molecular-weight multimers. sufferers with severe and reasonable aortic stenosis had significantly diverse values for closure time based on the platelet-feature analyzer and the ratio of collagen-binding pastime to antigen (medians, 173 and 107 seconds [P=0.007] and 0.sixty four and nil.eighty seconds [P=0.006], respectively). They did not differ within the percentage of highest-molecular-weight multimers, which become low in both corporations (median, 8 p.c in patients with severe aortic stenosis and 9 percent in those with moderate aortic stenosis). The effects did not vary in sufferers with O and non-O blood types. The stages of component VIII coagulant activity and von Willebrand antigen were normal in all sufferers (greater than 0.5 IU per milliliter).figure 1. figure 1. Relation between von Willebrand aspect Abnormalities and Severity of Stenosis, Represented as the suggest Transvalvular Gradient Plotted against the percentage of maximum-Molecular-Weight von Willebrand aspect Multimers (r = –0.56, P<0.001).

the road is the regression line.

Platelet-characteristic–analyzer values were positively correlated, and percentages of optimum-molecular-weight multimers were negatively correlated, with the imply transvalvular gradient (r = 0.fifty eight [P<0.001] and r = – 0.56 [P<0.001], respectively) and stenosis-brought on shear stress (r = 0.sixty five [P<0.001] and r = – 0.fifty nine [P<0.001], respectively) (figure 1). The ratio of collagen-binding undertaking to antigen became also weakly correlated with the suggest transvalvular gradient and stenosis-brought about shear stress (r = 0.37 [P=0.021] and r = 0.forty nine [P=0.007], respectively).

The platelet count changed into inside the usual latitude in all but two sufferers (one with severe and one with moderate aortic stenosis). circulation-cytometric evaluation discovered no change between patients and controls in platelet membrane–linked glycoprotein IIIa, von Willebrand element, or P selectin.

No big ameliorations in hemostatic values had been accompanied between patients with and sufferers without a preoperative historical past of bleeding.Surgical treatment

Eleven patients 65 years of age or younger received a mechanical bileaflet prosthetic equipment (Mira, Edwards, or Regent, St. Jude medical), and 31 patients over 65 years of age got a biologic equipment (29 pericardial valves [Perimount, Carpentier-Edwards], 1 stentless porcine aortic valve [Toronto, St. Jude Medical], and 1 cryopreserved aortic homograft [European Homograft Bank]). Mechanical contraptions were implanted in three patients with a preoperative heritage of bleeding.instant Postoperative path

The median blood loss 24 hours after valvular replacement changed into 415 ml (range, a hundred and twenty to 1580). One patient underwent reoperation for bleeding on the day after surgery. One other affected person died from ventricular fibrillation 10 days after surgical procedure.figure 2. figure 2. evaluation of highest-Molecular-Weight von Willebrand component Multimers in one affected person, earlier than and 3 Hours, 24 Hours, and seven Days after Valvular substitute.

Arrows point out the enviornment where the optimum-molecular-weight multimers migrate.

The platelet-function–analyzer values had been corrected in all sufferers on days one and seven. The levels of aspect VIII coagulant pastime and of von Willebrand factor antigen increased enormously by six months after surgical procedure, as compared with the preoperative values (P<0.001 and P=0.002, respectively). The percentage of maximum-molecular-weight multimers become corrected (i.e., was at least 10.5 percent) in all patients on days 1 and seven. The multimeric pattern of von Willebrand ingredient determined in a single patient three hours after surgical procedure became additionally normalized (figure 2).

The postoperative blood loss became drastically higher in sufferers with preoperative bleeding than in those with out preoperative bleeding (median, 565 ml [range, 195 to 1580] vs. 370 ml [120 to 700]; P=0.04). Six sufferers, all with a preoperative history of bleeding, had a blood loss enhanced than seven hundred ml. In these sufferers, the bottom-line percentage of optimum-molecular-weight multimers became vastly lower than in those and not using a extreme blood loss (P=0.007).comply with-up at Six Months in the patients Who Underwent surgery

Two sufferers were misplaced to observe-up at six months. One affected person presented with early homograft valve stenosis that required reoperation at six months. during this patient, repeated epistaxis changed into followed on the onset of restenosis. The different 38 sufferers have been asymptomatic at six months, without bleeding episodes, even those that had a preoperative background of bleeding and had a mechanical prosthesis requiring oral anticoagulant remedy. A mismatch between patient and prosthesis became observed in 10 cases.figure three. figure three. mean (±SE) Evolution of highest-Molecular-Weight von Willebrand aspect Multimers after Valvular replacement in sufferers with and patients without a Mismatch between patient and Prosthesis.

At six months, the platelet counts had been normal, and platelet flow-cytometric evaluation found no change from base line. The platelet-feature–analyzer values, besides the fact that children enormously reduce than at final analysis (P<0.001), have been irregular in sixty six percent of the sufferers (median, 189 seconds; range, 73 to 300). The percentage of optimum-molecular-weight multimers become below the general latitude in seventy four p.c of the sufferers (median, 8.7 p.c; range, 3.9 to 13). determine 3 suggests the time route of the percentage of multimers of highest molecular weight in response to the presence or absence of a mismatch between affected person and prosthesis. The percent changed into drastically decrease in sufferers with a mismatch (P=0.01). the lowest percentage of optimum-molecular-weight multimers changed into observed in the affected person with extreme homograft stenosis. There became no effect of the classification of prosthesis (mechanical or biologic) on the adjustments in hemostatic values.

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