Simplified TS Domain Generator for NonClinical Study Submissions

Who might want to use this application? The FDA Technical Rejection Criteria says this: "Sponsors whose studies started after December 17, 2016, must use the data standards listed in the FDA Data Standards Catalog for NDAs, BLAs and ANDAs. For Commercial INDs, the requirement applies to studies started after December 17, 2017...In order for the FDA automated eCTD validation process to determine the study start date (SSD) for the submitted study, FDA relies on the SSD value provided in the Trial Summary dataset (ts.xpt) that is referenced in the Study Tagging File (STF)." Therefore, if you are submitting study data as part of an NDA, BLA or ANDA that has had its protocol signed for the first time before December 17, 2016 or for an IND submission for a study that was signed before December 17, 2017 then you do not need to submit SEND datasets for all of the study data. You are, however, required to supply a simplified TS domain like the one that can be generated by this application. For further information, please look on the FDA's Study Data Standards Resources webpage.

How to use this application:

• Type the required STUDYID in the box labelled STUDYID. This must match the study ID in the STF tagging file unless the sponsor's reference id is used instead. Note that the download button will not be enabled until a value is entered into this box.
• If you require an alternate value from that of STUDYID in the STF tagging file, then enter that value in the SPREFID box and a second row will be populated in the dataset with the SPREFID parameter.
• Choose the study start date using the date chooser. This should be the earliest date the protocol was signed. The default is the latest date for which the Simplified TS domain is relevant.
Or

• If study start date is not available or not applicable, tick the checkbox to indicate this and TSVALNF will be populated with NA and STSTDTC will remain empty.
• A preview will appear on the bottom right once the study id has been entered. Use this to verify that the desired values are present in the dataset.
• When all choices have been made and are verified to be correct, press the button labelled "Download" to download the ts.xpt.