ABSTRACT

The difference between SDTM and ADaM Data checks and CDISC Data Compliance checks is that now the focus is on data content and CDISC structure rules. CDISC data compliance checks are broken down into SDTM and ADaM consistency checks. SDTM examples of these checks include consistency between AENUM and CMAENUM and between RELREC and SDTMs. ADaM checks include valid DTYPE values and consistency between the analysis visit window and protocol. The CDISC data compliance checks must pass through Pinnacle 21 checks.