SAS® Macros for Redacting Subject and Clinical Site Codes while Submitting Clinical Trial Data to FDA
Year of Publication
Philadelphia Area SAS Users Group (PhilaSUG) Winter 2017 Meeting
Blue Bell, PA
One of the final steps in the submission of a clinical study report to the FDA involves the submission of clinical datasets with protected subject and site information. The objective of this paper is to develop SAS macros for redacting subject and clinical site codes in clinical datasets with dummy codes. In this regard, macro ‘DUMMY_CODE_MAKER’ and macro ‘MERGE_MAKER’ are created with SAS macro language using DATA step, SQL, SORT and PRINT procedures of SAS. Application of the macros is explained with a model SDTM dataset - Demographics (DM).