China CRO - SAS macros of statistical data analysis, Data Management System for clinical trial

ClinStReport Applications

SAS macros, DM system for clinical data management, analysis and reporting

Briefing of ClinStReport

ClinStReport, specifically designed for the pharmaceutical industry, is a fully integrated SAS based macro reporting system for the analysis and reporting of clinical trials. This powerful software tool simplifies and streamlines the clinical data reporting process and produces the most popular layout used in pharmaceutical industry. ClinStReport can generates SAS dataset, text output and real RTF output. ClinStReport provides online helps and ClinStReport can stop promptly with exact error message when it comes across accidental problems. 　

ClinStReport has 5 major macros open for use

Report of demographic data: %mAr0c1

Report of Repeat Measurement: %mRr1c1; %nRr1c1; %fRr1c1

Report of Adverse Events or concomitant Medication: %mXr1c2

Understanding ClinStReport

General rules of Naming the macros in ClinStReport

letters	Stands for	Example
1^st	“m”: macro “m”: used for both continuous and categorical data “n” : used for continuous data only “f”: used for categorical data only	% mReport; % mXr1c2 % mAr0c1; % mRr1c1 % nRr1c1 % fRr1c1
2^nd	“A”: Single-choice Questions e.g. Age, Sex “X”: Mutiple-choice Q uestions e.g, AE or Medications “R”: Repeat Measurement	%mAr0c1 %mXr1c2 %mRr1c1;%nRr1c1; %fRr1c1
3^rd -4^th	“r0” :No grouping variable in row allowed “r1”: Maximum 1 grouping variable in row allowed	%mAr0c1; %mRr1c1;%nRr1c1; %fRr1c1;%mXr1c2
5^th -6^th	“c1”:Maximum 1 grouping variable in column allowed “c2”:Maximum 2 grouping variable in column allowed	%mAr0c1 ; %mRr1c1 %nRr1c1 ; %fRr1c1; %mXr1c2

General rules of Naming macro parameters in ClinStReport except macro(mReport)

Parameter	Property	Default	Apply To	Explanation
append	Optional	new	mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1; mReport	Specify output destination to a new file or append to an existed file when parameter file is assigned a value: - New : New file - Yes : append to an existed file
c1Group	Optional		mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1	Specify a group (BY) variable (presented in column-dimension )
c1total	Optional	yes	mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1	Request summary statistics of the variable assigned by c1Group -Options: Yes or No
dfMethod	Optional		fRr1c1 ; mRr1c1	Specify statistical method to analyze paired categorical data. Agree is the only choice. McNemar's test for 2 ×2 table, for square tables with more than two response categories, Bowker's test of symmetry;
dMethod	Optional		mRr1c1; nRr1c1	Specify statistical method to analyze paired continuous data. - pairt : Paired T test - msign : Nonparameter sign test - signrank : Nonparameter sign rank test
File	Optional		mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1; mReport	Routing macro output to a physical file, eg: C:\test , the extension of the file will be .txt if filetype=text or filetype=rpt, be .DOC if filetype=rtf
fileType	Optional	text	mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1; mReport	Specify types of output produced -text: Generate plain text output -RTF: Generate RTF output -RPT: Generate output by proc report
fMethod	Optional		mAr0c1; mXr1c2; mRr1c1; fRr1c1	Specify statistical method when testing categorical data. - X2 : General chi square test - EXACT : Fisher’s exact test
InSet	Required		mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1; mReport	Specify a SAS dataset to be analyzed
nMethod	Optional		mAr0c1; mRr1c1; nRr1c1	Specify statistical method when testing continuous data. - ANOVA : F test - WILCOXON : Wilcoxon/ Kruskal-Wallis test
nStyle	Optional	b	mAr0c1; mRr1c1; nRr1c1	Request different layout to display statistics of continuous data Available choice: A or B
OutSet	Optional		mAr0c1; mXr1c2; mRr1c1; nRr1c1; fRr1c1	Routing macro output to a SAS dataset, values assigned should be a valid SAS dataset name
r1Group	Optional		mXr1c2; mRr1c1; nRr1c1; fRr1c1	Specify a group (BY) variable (presented in row-dimension )
vAnalyst	Required		mXr1c2	Specify the variable to be analyzed
vDrop	Optional		mAr0c1; mRr1c1 nRr1c1; fRr1c1	Specify variables NOT to be analyzed
vId	Required		mXr1c2; mRr1c1; nRr1c1; fRr1c1	Specify the variable that identifies subjects(patients), ie observations with the same vId value are taken from the same subject
vKeep	Optional		mAr0c1; mRr1c1 nRr1c1; fRr1c1	Specify variables to be analyzed

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Addr: Room 203, No 8, 165 Mudan Road, Pudong, Shanghai, P.R. China 201204

Tel: (510)-331-2327(US) ; +86 13916348130(CN)

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