Stay Aware: SEND Guidance Updates
The United States Food and Drug Administration (US FDA) recently published the effective dates for the Electronic Common Technical Document (eCTD) – Technical Rejection Criteria (TRC) for Study Data, along with the eCTD Validation Criteria. To help with eCTD Validation Criteria, the TRC self-check worksheet includes instructions and a video on how to use the worksheet. The TRC was updated to reflect the effective dates for the implementation of the TRC on the US FDA’s website: Study Data for Submission to CDER and CBER | FDA.
The US FDA published information can be found here:
- Electronic Common Technical Document (eCTD) | FDA
- Technical Rejection Criteria for Study Data (fda.gov)
What does this mean for non-clinical study data?
This simply means beginning September 15, 2021, the US FDA plans to implement eCTD validation checks for study information submitted within certain sections of module 4 of the eCTD. Submissions that fail the validation criteria will be subject to rejection.
The study data standards requirement dates are listed on the Study Data Standards Resources page within the Data Standards Catalog.
The scope of the SEND study data requirements are as follows for studies submitted to US FDA CDER:
- Studies that started after December 17, 2016 (protocol signature date) for a New Drug Applications (NDAs), an Abbreviated New Drug Applications (ANDAs) and a Biologics License Application (BLAs).
- Studies that started after December 17, 2017 (protocol signature date) for Commercial Investigational New Drugs (INDs).
Any non-clinical study information filed within the eCTD Module sections, 188.8.131.52, 184.108.40.206, 220.127.116.11, must meet the minimum standards:
- If the study was conducted before the requirement dates, a simplified ts.xpt is required. Sponsors have two options:
- Request their Contract Research Organization to create a simplified ts.xpt for an additional fee
- Create their own. Available resources on how to do so can be found on the US FDA’s Study Data for Submission to CDER and CBER webpage: Simplified ts.xpt Creation Guide
- If the study was conducted after the requirement dates, a fully compliant SEND dataset package is required including, but not limited to, a ts.xpt, dm.xpt, and define.xml
Charles River encourages Sponsors to review all the material related to the eCTD TRC as soon as possible to ensure your submission does not get rejected.
How is this different from the original technical rejection criteria?
The technical rejection criteria have always been required since initial publication, but they were not implemented and turned on by the US FDA. The FDA was monitoring the submissions and presenting their findings to industry about the issues encountered, via the CDER Small Business and Industry Assistance (SBIA) webinars. Submissions received from Sponsors between March 15 and September 15, 2021 will receive warnings from FDA when a TRC error is identified. Warning notices will specify each error and provide the error code, error reason, STF Study ID, and eCTD Section (if applicable).
Beginning September 15, 2021, if the submission fails the validation criteria the submission could be subject to rejection.
Is Charles River fully prepared to develop SEND datasets required by the FDA?
Simply, Yes. Over the past 14 years since SEND’s inception in 2007, our SEND experts have been dedicated to providing the necessary datasets by the dates they are requested. Our SEND team successfully deliveries over 450 SEND dataset packages/studies per month.
Our SEND Expert & Active CDISC SEND Industry Team Lead
Director, SEND, DRDS