SAS/TS-SDTM.sas at main · dimpz4295/SAS · GitHub

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
/*Make all variables upper case. Set library name to nct0285.*/
libname nct0285 "/home/u63567925/sasuser.v94/0mycsg/nct0285";
options validvarname=upcase;

*==============================================================================;
*Create SDTM program for Trial Summary (TS) Domain for
Effect on Non-small Cell Lung Cancer Trial;
*==============================================================================;

data ts;
	length studyid $10 domain $2 tsseq 8 tsparmcd $8 tsparm $200 tsval $200 tsvcdref $100 tsvcdver $20;
	label studyid="Study Identifier" domain="Domain Abbreviation" tsseq="Sequence Number"
	tsparmcd="Trial Summary Parameter Short Name" tsparm="Trial Summary Parameter"
	tsval="Parameter Value" tsvcdref="Value Reference" tsvcdver="Version of the Value Reference";

*------------------------------------------------------------------------------;
*Set variables for studyid & domain.
*------------------------------------------------------------------------------;
	studyid="NCT0285";
	domain="TS";

*------------------------------------------------------------------------------;
*Set variables for Trial summary parameter denoting Placebo.
*------------------------------------------------------------------------------;
	tsseq=1;
	tsparmcd="TCNTRL";
	tsparm="Control Type";
	tsval="Placebo";
	tsvalcd="C49648";
	tsvcdref="CDISC CT";
	tsvcdver="2025-03-28";
	output;
/*Reset variable values to missing for next trial summary parameter.*/
	call missing(tsseq, tsparmcd, tsparm, tsval, tsvcdef, tsvcdver);

*------------------------------------------------------------------------------;
*Set variables for Trial summary parameter denoting Investigational Therapy/Treatment.
*------------------------------------------------------------------------------;
	tsseq=1;
	tsparmcd="TRT";
	tsparm="Investigational Therapy or Treatment";
	tsval="Atezolizumb";
	tsvalcd="52CMI0WC3Y";
	tsvcdref="UNII";
	tsvcdver="";
	output;
/*Reset variable values to missing for next trial summary parameter.*/
	call missing(tsseq, tsparmcd, tsparm, tsval, tsvcdef, tsvcdver);

*------------------------------------------------------------------------------;
*Set variables for Trial summary parameter denoting Sponsor.
*------------------------------------------------------------------------------;
	tsseq=1;
	tsparmcd="SPONSOR";
	tsparm="Clinical Study Sponsor";
	tsval="Genentech, Inc.";
	tsvalcd="0801290006";
	tsvcdref="D-U-N-S NUMBER";
	tsvcdver="";
	output;
/*Reset variable values to missing for next trial summary parameter.*/
	call missing(tsseq, tsparmcd, tsparm, tsval, tsvcdef, tsvcdver);

*------------------------------------------------------------------------------;
*Set variables for Trial summary parameter denoting Study Title.
*------------------------------------------------------------------------------;
	tsseq=1;
	tsparmcd="TITLE";
	tsparm="Trial Title";
	tsval="A Phase II Single-Arm Study Of Atezolizumabmonotherapy In Locally Advanced Or
	Metastatic non-Small Cell Lung Cancer: Clinical Evaluation Ofnovel Blood-Based Diagnostics";
	tsvalcd="";
	tsvcdref="";
	tsvcdver="";
	output;
/*Reset variable values to missing for next trial summary parameter.*/
	call missing(tsseq, tsparmcd, tsparm, tsval, tsvcdef, tsvcdver);

*------------------------------------------------------------------------------;
*Set variables for Trial summary parameter denoting Trial Disease.
*------------------------------------------------------------------------------;
	tsseq=1;
	tsparmcd="INDIC";
	tsparm="Trial Disease/Condition Indication";
	tsval="Non-Small Cell Lung Cancer";
	tsvalcd="254637007"
	tsvcdref="SNOMED";
	tsvcdver="2025-08-31"
	output;
/*Reset variable values to missing for next trial summary parameter.*/
	call missing(tsseq, tsparmcd, tsparm, tsval, tsvcdef, tsvcdver);

*------------------------------------------------------------------------------;
*Set variables for Trial summary parameter denoting Trial Phase.
*------------------------------------------------------------------------------;
	tsseq=1;
	tsparmcd="TPHASE";
	tsparm="Trial Phase Classification";
	tsval="Phase II Trial";
	tsvalcd="C15601"
	tsvcdref="CDISC CT";
	tsvcdver="2025-03-28";
	output;
/*Reset variable values to missing for next trial summary parameter.*/
	call missing(tsseq, tsparmcd, tsparm, tsval, tsvcdef, tsvcdver);

run;