SAS XPT Files
SAS transport file (.xpt file) will be provided as outputs of MedXview’s software DefineGen™. We will reformat the CRT dataset if the CRT dataset from CRO which are not compliant with current FDA requirements. MedXview will provide all SAS programs which generate new CRT datasets, one CRT dataset will associate with one SAS program. QA logs will be provided by MedXview as well as a detailed comparison between new CRT and old CRT datasets. MedXview will ensure 100% accuracy of the data.

FDA and CDISC Guidance Compliance
For each CRT data set, MedXview will produce a define.pdf file per FDA guidance that includes the name, label, format, origin, key order length and comments. etc. The definition tables (Define.PDF) are the reflexes of the data model as defined by the company’s own practice.  Additional components can be added into a definition table (define.pdf) if that is needed by using MedXview DefineGen. A Define.xml (following CDISC guidance) will also be provided by MedXview’s software, DefineGen™, automatically. All SAS datasets and formats will be provided in both xpt format and XML formats.