Dating rules to my future self wiki
Please contact [email protected] for additional advice about such a submission.Is SEND mandatory for study types that were not piloted?For example, if there is a safety pharm study with body weights, will the body weights need to be submitted?The Study Data Standards page provides current expectations/recommendations.As a reminder, the Technical Rejection Criteria are available on the FDA Study Data Standards page.When do the Technical Rejection Criteria go into effect?Note that while typical study types will be piloted, but a study type need not be piloted to be specified by the Study Data Standards page to be mandatory.However, electronic submissions of data are encouraged, even when the study type is not yet mandatory.
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?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?There were several variables added in SDTM v1.3, e.g., TSVALNF, TSVALCD, TSVCDREF, and TSVCDVER.If it is for legacy data submission, you don’t need to include those variables for TS.