SAS scripts for clinical trials applications including generating SDTM domains, ADaM datasets, and Define.xml files.

Important: The data and programs in this toolset were derived from Holland and Shostak (2012). However, extensive modifications were made throughout the data and programs. All the programs are fully tested and correctly functional under SAS University Edition and Windows 10 OS.

1. Preprocess programs

a) "common.sas": common library settings

b) "dm.sas": reads in "dm.csv" to process raw demographic data

c) "ae.sas": reads in "ae.xlsx" to process raw adverse event data

d) "ds.sas": reads in "ds.xlsx" to process raw dosing data

e) "pn.sas": reads in "pn.dat" to process raw pain score data

f) "lab.sas": reads in "lab.xls" to process raw labs data

2. "Define.xml" program

"make_define.sas": contains a macro "%make_define" to generate parts of the define.xml file for the SDTM and ADaM, which can be further concatenated into the define.xml file.

3. SDTM programs

a) "make_empty_dataset.sas": contains a macro "%make_empty_dataset" to generate an empty domain dataset according to the variable list specified in the metadata file "SDTM_METADATA.xlsx".

b) "make_sdtm_dy2.sas": contains a macro "%make_sdtm_dy2" to generate study day for date variables.

c) "make_sort_order.sas": contains a macro "%make_sort_order" to generate a macro variable which contains the keys for ranking a SDTM dataset.

d) "sdtm_dm.sas": generates the SDTM DM and SUPPDM domain datasets from "dm.sas" and "ds.sas" outputs.

e) "sdtm_ae.sas": generates the SDTM AE domain dataset from "sdtm_dm.sas" and "ae.sas" outputs.

f) "sdtm_EX.sas": generates the SDTM EX domain dataset from "sdtm_dm.sas" and "ds.sas" outputs.

g) "sdtm_lb.sas": generates the SDTM LB domain dataset from "sdtm_dm.sas" and "lb.sas" outputs.

h) "sdtm_xp.sas": generates the SDTM XP domain dataset from "sdtm_dm.sas" and "pn.sas" outputs.

4. ADaM pprograms

a) "setup.sas": contains library and format settings.

b) "cfb.sas": contains a macro "%cfb" to generate baseline values and change from the baseline.

c) "dtc2dt.sas": contains a macro "%dtc2dt" to convert character date to numeric date.

d) "mergesupp.sas": contains a macro "%mergesupp" to merge supplemental qualifiers into the parent SDTM domain.

e) "adam_adsl.sas": generates the ADaM ADSL domain dataset from "sdtm_dm.sas" and "sdtm_xp.sas" outputs.

f) "adam_adae.sas": generates the ADaM ADAE domain dataset from "adam_adsl.sas" and "sdtm_ae.sas" outputs.

g) "adam_adef.sas": generates the ADaM ADEF domain dataset from "adam_adsl.sas" and "sdtm_xp.sas" outputs.

h) "adam_adtte.sas": generates the ADaM ADTTE domain dataset from "adam_adsl.sas", "adam_adae.sas" and "adam_adef.sas" outputs.