So all submitted datasets should be validated against the metadata in the Now you will say "Wait a minute Jozef, being valid against the metadata in the doesn't mean that the datasets are in accordance with what is written in the corresponding IG". So the should always be to validate the contents of the against the contents of the IG.
In 2010, the FDA’s Center for Drug Evaluation and Research published a data standards plan recommending CDISC standardization for the submission of clinical trial data.: To check for compliance, the validation of domains can be done using SAS. For example, P2W is same as TEENRL like “2 weeks after the time period of Element”.The programmers should adhere to company’s standard operating procedures and programming standards to support the creation of SDTM metadata files. 3) : Specifies Inclusion/ Exclusion criteria and contains the following variables. If the criteria changes, TIVERS should change as per protocol amendment.This non-statistical programming time will be significantly reduced after implementing the CDISC standards.3) What are the challenges as SAS programmer you think you will face when you first implement CDISC standards in 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. 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.