FDA provides more detail on the Scope of SEND

This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the highlight of the week was the FDA public meeting. As you may imagine, this time it was dominated by discussions around the recent addition to the Technical Conformance Guide (TCG), momentously entitled the “Scope of SEND”.

I previously wrote about this when the FDA mentioned it at last year’s public meeting, and again when the recent TCG dropped. Then last week, the agency took the opportunity to take it apart, explaining their thinking and adding clarity.

The public meeting started with a reference back to the binding guidance. To serve as a reminder, that this is not optional, or subjective, and directly flows from that oh-so-important 2014 Guidance. Reinforcing the message that the recent TCG update is not adding anything new, it’s simply clarifying the position that harks back to that 2014 publication.

It was this time last year that the FDA clearly stated to industry that, although the Technical Rejection Criteria references the eCTD sections, the guidance doesn’t limit SEND requirements in the same way. A year later, we get a very detailed insight.

Without going into excessive detail, the guiding principle is this:

• If the study starts after the requirement date, and;
• The study needed to assess and support the safety of clinical investigations, and;
• The study data can be represented in SEND;

Then the study requires SEND for submission.

Things like the age of the subjects, whether or not the study is GLP and the study report status were all discussed. It was clearly stated that these things do not affect whether or not the study requires SEND.

For some sponsors, this now causes a significant issue for certain studies. They may have studies already completed by their CRO, that at the time, incorrectly assumed that the study wouldn’t require SEND because it was in an eCTD section not covered by the Technical Rejection Criteria. So, they may have completed studies without SEND, which actually require SEND. However, fortunately for them, specialist SEND organisations like Instem can take completed studies and create SEND from the study report; allowing them to be compliant, even if they didn’t realise that SEND would be required when they initiated the study.

The FDA presentation also went to great lengths to talk about the value of SEND for regulatory purposes.  They described its value for primary reviews, and how it also assists in secondary and tertiary reviews. They described how SEND is “…used to conduct reviews that will impact regulatory decisions”.

Actually, it’s really inspiring hearing this, at a CDISC meeting focused on driving the SEND standard forward. The general feeling in the (virtual) room was really appreciative of the FDA’s openness in this way.

Till next time,

Marc