Recent expedited U.S. Food & Drug Administration (FDA) review in response to our public health emergency demonstrates efficiencies that can be attained with true implementation of standardized data. In order to provide a standardized electronic dataset for your nonclinical data which will fulfill regulatory electronic common technical document (eCTD) submission requirements, you must SEND. Use of SEND enhances data review, enables data warehousing, data analysis and data visualization in addition to having a set of controlled terminology for our industry. The FDA requires a SEND dataset for non-GLP studies if those studies are part of your submission, as well as for the customary GLP studies. The FDA provides guidelines to help researchers submit Trial Summary files (ts.xpt) to meet study data requirements for both CDER and CBER, which streamlines the agencies’ review process. An active automated check/rejection of studies that do not have study data in compliance with the requirements specified in the FDA Data Standards Catalog becomes effective on September 15, 2021, hence you must SEND, or your dataset will be rejected.
If you are not “SEND’ing”, you will put your program development at risk. Did you know that Attentive has the experience and utilizes industry compliant software such as Instem’s submitTM to help convert your study reports to data types presented in separate domains (e.g., body weight domain), plus other multiple domains to compile a unique SEND dataset per study for your regulatory filing?
Typical files submitted for nonclinical studies are:
.xpt; Your data.xpt files are files that would be submitted to the FDA and should be reviewed by your stakeholders including your contract lab if applicable, prior to submission.
.xml, .xsd and .xsl; These are Your “define” files which provide an explanation for the terminology utilized as well as the data files included in the dataset.
SEND DM, SDTM and STF; These are your SEND demographic, data translation model and study tagging files respectively.
.nSDRG; is a guide in pdf format for the reviewer which facilitates explanation of the study design, data set, and noting any specific variations or differences from the study report or nonstandard terminology.
Healthier outcomes are exigent, and paying attention cannot and should not be ignored. Attentive employs State of the Art technology for data collection, monitoring and report compilation, which ensures that your data package submitted to the U.S. FDA and other worldwide regulatory agencies is compliant with the guidelines and requirements of SEND as well as 21 CRF Part 11 regulations for electronic records.
Is your non-clinical study data package, which should include your safety pharmacology studies being prepared to support the Standard for the Exchange of Nonclinical Data Implementation Guides (SENDIG V3.0 and V3.1)? At Attentive, we plan along with you to ensure your data is SEND compliant and your timelines are preserved.