Dating rules to my future self wiki
30 days after publish on the FDA Study Data Standards page. Just TSPARMCD=STSTDTC is explicitly required (for legacy studies under covered study types, e.g., single dose, carc, etc.). There are new variables added in the base SDTM after the SENDIG was published.Will FDA accept submissions with these not included?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?As to officially posted policy, if you submit SEND after 2016-12-17, TS is required.For legacy cases (e.g., only the report), then only the short version TS is required (single row TS; no DM or Define). How will my study reports from a CRO change when SEND files are used? However, it is a longer term goal for the SEND datasets to eventually replace the individual tabulated datasets. To open XPT files, you have a few options: When opened, they appear similarly to Excel workbooks.However, in general, this is encouraged by the FDA.What is the status of the FDA pilots (CDER, CVM, CBER)? SEND will only be a requirement in the United States for certain FDA submissions.
However, electronic submissions of data are encouraged, even when the study type is not yet mandatory.
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?
Please see the Study Data Standards page for pilot status. The FDA uses the files for the review process, via the Nonclinical Information Management System (NIMS) suite. However, it has operational use, such as transfer between organizations, sponsor warehousing, etc., such that it is a good idea to produce SEND datasets, even if not technically required for submission.
This suite provides tools that are built to use SEND datasets' information, such they are able to review a submission more efficiently than when they receive only PDF or printed submissions that contain the individual animal data. As far as the European Medicines Agency (EMA) goes, the Clinical Trial Advisory Group on clinical trial data formats (CTAG2) is working on advising the EMA on clinical data formats, where it is leaning toward CDISC standards (although if it accepts, it would likely follow a similar progression as the FDA, with a 2-3 year pilot.
Before loading the files, their gateway will first perform validation checks against the data to make sure they are SEND-compliant. Here is a link to the recommendations CTAG2 provided the EMA: Final advice to the European Medicines Agency from the clinical trial advisory group on Clinical trial data formats.