A SEND Update: What to Expect from the FDA SEND Dataset Pilot Review

//A SEND Update: What to Expect from the FDA SEND Dataset Pilot Review

A SEND Update: What to Expect from the FDA SEND Dataset Pilot Review

Jamie Megna, SEND Data Architect
Christy Kubin, SEND Data Architect

We recently participated in the October Standard for Exchange of Nonclinical Data (SEND) Face-to-Face meeting between the FDA and industry. We want to share with you our take-a-ways on the latest SEND developments from this productive session. The FDA is encouraging the industry to submit sample SEND datasets for technical review and the FDA described the process for submitting sample datasets. It is important to closely follow the process described on the FDA website to avoid potential delays in the review process.

When submitting sample datasets, here are some helpful tips to keep in mind.

  1. Once you have received an application number, carefully follow the instructions provided in the email from the FDA eData team.
  2. Samples must not be submitted through the electronic gateway. The sample datasets should be saved to CD, DVD, or flash drive and be mailed to the address provided.
  3. The technical review could take up to 30 days. During this time do not expect to hear from the eData team.
  4. Feedback will be emailed to the primary contact listed on the sample cover letter.
  5. Questions regarding the SEND datasets should be sent to EDATA@fda.hhs.gov.
  6. Questions regarding the sample submission process should be sent to ESUB@fda.hhs.gov

This piloting process should be considered an essential best practice for all companies that will be creating or submitting SEND datasets. Submitting a sample SEND dataset package to the FDA will verify that the datasets can be successfully loaded into the Nonclinical Information Management System (NIMS) and are suitable for review. Once the sample SEND datasets are received, they are uploaded into NIMS. The sample SEND datasets are also sent to the Data Standards group for additional review. Data are never commingled with the production server or shared with review teams.

It is important to understand the scope of the FDA sample SEND dataset review to be able to interpret the feedback accurately. The FDA review is a technical review of your SEND dataset submission. As such, it will provide you with valuable information regarding your dataset’s compatibility with the FDA systems. You will be told whether or not your sample dataset was able to successfully load into NIMS. The FDA validator tool will provide results, which will allow you to view any errors and warnings that were produced when your sample SEND dataset was run through the validator.

The FDA review is not a content review. This means that you will not get detailed feedback on the population of variables within a domain, the appropriateness of the data you included in the domain, or any other content- related questions that you may have. The comments that you will receive regarding domains and variables will generally be limited to the errors/warnings produced by the validator. Similarly, you will not receive detailed feedback on the content of your define file or Study Data Reviewer’s Guide. The FDA review will provide you with the assurance that your SEND dataset package meets the technical requirements to successfully load into the NIMS for review. It provides you with the opportunity to work out any technical issues before submission and to converse with the FDA regarding technical requirements.

A successful pilot provides peace of mind that the submission process should proceed smoothly once SEND datasets are required.

By |2017-07-04T10:26:48+00:00December 10th, 2015|Blog|Comments Off on A SEND Update: What to Expect from the FDA SEND Dataset Pilot Review

About the Author:

MPI Research, with global headquarters in Mattawan, Mich., provides safety evaluation, discovery, bioanalytical and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. The company offers comprehensive imaging solutions including preclinical imaging, radiochemistry, and data analysis. Scientific knowledge and experience, responsiveness, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.