With the new requirements of electronic submission, CRT datasets need to conform to a set of standards for facilitating REVIEWING process. They no longer are created solely for programmers convenient. SDS will be treated as specifications of datasets to be submitted, potentially as REFERENCE of CRF design.

Therefore, statistical programming may need to start from this common ground. All existing programs/macros may also need to be remapped based on CDISC so one can take advantage to validate submission information by using tools which reviewer may use for reviewing and to accelerate reviewing process without providing unnecessary data,tables and listings.

With the new requirements from UPDATING electronic submission and CDISC implementation, understanding only SAS® may not be good ENOUGH to fulfill for final deliverables. It is a time to expand and enhance the job skills from various aspects under new change so that SAS® programmers can take a competitive advantage, and continue to play a main role in both statistical analysis and REPORTING for drug development.

With the new requirements of electronic submission, CRT datasets need to conform to a set of standards for facilitating reviewing process. They no longer are created solely for programmers convenient. SDS will be treated as specifications of datasets to be submitted, potentially as reference of CRF design.

Therefore, statistical programming may need to start from this common ground. All existing programs/macros may also need to be remapped based on CDISC so one can take advantage to validate submission information by using tools which reviewer may use for reviewing and to accelerate reviewing process without providing unnecessary data,tables and listings.

With the new requirements from updating electronic submission and CDISC implementation, understanding only SAS® may not be good enough to fulfill for final deliverables. It is a time to expand and enhance the job skills from various aspects under new change so that SAS® programmers can take a competitive advantage, and continue to play a main role in both statistical analysis and reporting for drug development.