SEND Resources & Answers

There are so many helpful resources available for those who need insights regarding SEND and the respective guidelines. It is your responsibility as the biotechnology or pharmaceutical company to review and submit the SEND datasets to the FDA. With regulations changing regularly, you can always get the answer to your questions through the Charles River SEND team. Over the last year, our experts have completed 3,300+ SEND datasets.

 

Access SEND Guidelines

CDISC and PhUSE all offer websites that offer guidelines and additional documents that can help you along the way. Our experts have shared these specific resources with you.

CDISC SEND

Study Data Technical Conformance Guide and Data Standards Catalog

Electronic Common Technical Document (eCTD) and Technical Rejection Criteria

FDA Study Data Standards Resources

PhUSE Implementation Wiki

 

Frequently Asked Questions

Not only do you have questions regarding submission details and guidelines, you may have SEND related questions about study types, programs, etc. Download a comprehensive document that includes answers to cardiovascular, respiratory, IND, and gene therapy study compliance.

Explore more SEND questions

When do the SEND CBER requirement take effect?
For biologic development, CBER SEND will soon be required for studies that are started 24 months after the transition date of March 15, 2021 will require SEND data sets. Studies started March 15, 2023 or later must be submitted to CBER using SEND.

How will SEND v3.1.1 be implemented? Will the FDA issue an FR notice with dates?
Typically, when the FDA is ready to accept a standard that version of the standard will be added to the FDA Data Standards Catalog with support dates. An FR notice is generally not needed in order to add a standard to the catalog; however, one can be issued.

We’ve heard the FDA is giving a 30-day grace period for the filing of SEND datasets with a submission requiring datasets; can you confirm this?
We have not heard of any grace period, and this information conflicts with other information we have received from FDA. We suggest that you contact eDATA to get an official response from FDA on this subject.

Which define file should you submit to the FDA if there are multiple define files?
Define 1.0 the following files must be submitted: define.xml, define1-0-0.xsl, define.css, define.pdf.

Define 2.0 mandated on and after March 15, 2019, the following files must be submitted: define.xml, define2-0-0.xsl, define.css.

If I have a Word and PDF version in the SEND package, should I remove the Word version from the package before submitting to the FDA?
Yes. Only the PDF version of the nSDRG should be included in the submission.

Once SEND datasets are finalized and sent to my company, are there any additional steps needed for electronic publishing and submission to FDA?
Charles River provides a submission-ready SEND dataset package. You will just need to incorporate those files into your eCTD structure to submit.

Do you provide a study data reviewer guide for each study that requires SEND datasets?
A Nonclinical Study Data Reviewer's Guide (nSDRG) will be provided with each SEND package.

If we get a SEND dataset from our CMO, are there any free programs available to open and review the dataset?
You can use the SAS Universal Viewer to view SEND datasets.

How do you populate the MICHRON and MIDISTR variable with 3.1?
MICHRON and MIDISTR are populated according to the controlled terminology for these variables.

If a study examines special biomarkers related to mechanism of action, are these to be included in the SEND package?
Standard biomarkers are in-scope for SEND and will be included. If there are special biomarkers that are not within-scope it will be mentioned in the nSDRG.

Is it standard that SEND will be required on studies and that PIs will need to provide their domains? Do you handle this or is it a Sponsor’s responsibility to discuss SEND with each study contributor?
The Sponsor should ensure that each third party can provide SEND domains for their portion of the study or arrange for SEND conversion for those data. Charles River will create a single integrated SEND dataset.

Would you choose SEND or INHAND to do data mining within toxicologic pathology data?
The choice between SEND and INHAND should be made based on the needs of your organization.

Should in vivo drug-drug interaction studies be SEND-compliant?
SEND is required single dose toxicity, repeat-dose toxicity and carcinogenicity studies if the study protocol was signed on or after December 17, 2016. SEND is also required for cardiovascular and respiratory studies if the study protocol was signed on or after March 15, 2019.

Is the SEND database applicable for a local tolerance study that involves repeated dose administration for 14 days?
Yes. If this study protocol was signed on or after December 17, 2016 and this study will be submitted in eCTD section 4.2.3.2 Repeat-Dose Toxicity. If the study is a local tolerance study as defined (a toxicology study that assesses the effects of a substance when administered to a restricted portion of the body) in the eCTD structure 4.2.3.6, these studies should be filed in the local tolerance section 4.2.3.6 of the eCTD structure and do not require SEND.

Is SEND also in effect for animal rule studies?
SEND is required for animal rule studies (see SENDIG-AR-v1.0). SENDIG-AR-v1.0 will be required for studies starting on or after March 15, 2022 (protocol signature date). Please see the Data Standards Catalog on the FDA's Study Data Standards Resource page


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Fielding Your Questions; Two of Our SEND Experts

Audrey Walker head shot

Audrey Walker
Director, SEND, DRDS

Christy Kubin head shot

Christy Kubin
Associate Director, SEND, DRDS