Aug
15
- Joanna Koft
- 15/Aug/2011 08:00
As our industry standard of regulatory submissions shifts towards CDISC-compliance, sponsors must adopt new processes to support the shift. With the implementation of the submission standards of SDTM, ADaM, and Define.xml, this adds up to a plethora of new processes and responsibilities. SDTM alone encompasses many of these new processes….including new tasks such as SDTM annotation of CRFs, creation of SDTM metadata specifications, programming of SDTM datasets and parallel programming/QC of SDTM datasets. This puts additional pressures on groups such as statistical programming to be able to efficiently get their work done while adhering to new data standards.