Note that this stipulation applies to CT active at the time of the creation of the SEND package for the study. The intent is to phase out in the future, in that it can be generated from a SEND package. As always, consult the Technical Conformance Guide (as referenced in the Study Data Standards page) to see what is or isn't required.For instance, if a SEND package is created for a study in 2013 and not submitted until 2017, the CT to which it must adhere is the CT active at the time of the packaging (e.g., 2013 or shortly before it). How do I know whether SEND is mandatory for any given endpoint? Is endpoint ___ required for a study type that isn't required?This makes the process of mapping data into SDTM and ADa M datasets much more straightforward.
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is working to adopt CDISC standards including SEND. (Note: this pertains to updates made the initial SEND requirement laid out in the previous question, e.g., IG updates, new study types, etc.) After new standards or updates are published, pending an evaluation by CDER, CDER will add the standard to the Study Data Standards Resources page with a timeframe for requirement.
At the April 2014 CDISC Europe Interchange, Yuki Ando presented their plans for adoption at some point after FY2017. The timeframe for these will be at least after the standard/version is added to the page, and will apply only to new studies.
For more information see the following PMDA page: When new study types or versions of the SEND Implementation Guide are brought online, when will they be required? When will Respiratory and Cardiovascular be required? It is expected that larger scale additions (such as completely new subject areas) will have a longer timeframe for Sponsors to implement and ramp up before it becomes required.
Note: When will new Controlled Terminology be required?
They can even produce ad-hoc reports and perform It will be very useful for the sponsor to run the Web SDM checks on the clinical data because the FDA reviewers also use the same application to review the data.