December 17, 2016, is less than five months away.
As we all know by now, studies starting on or after that date must be submitted to the Food & Drug Administration electronically. They must also utilize the most-recent FDA-acknowledged version of data standards.
To support the latter point, FDA is requesting that sponsors submit a Study Data Standardization Plan (SDSP) as part of the IND application.
With time running out quickly, two big questions have taken on a new urgency:
For some time now, FDA has been pursuing a more efficient and faster review process. Asking sponsors to begin developing the SDSP at the IND, and presenting it at the EOP2 meeting with the agency, is a logical extension of this goal. FDA wants ample opportunity to comment on the standards used, while giving sponsors sufficient time to improve the package reviewability.
So, the reasoning behind the request, and its importance, are clear. Unfortunately, executing against this request can be a murky and troublesome journey.
That is to say, complying with FDA’s request — creating an SDSP — is much more complex than it seems.
Sponsors should be able to simply access the Data Standards Catalog to identify the most current versions of the standards (CDISC and otherwise) at study start-up, implement those standards, and disclose them in the SDSP. But that approach is surprisingly complicated and rife with problems.
Now, a sponsor could use a template, which has been developed to help simplify the creation of an SDSP … but the use of the template is hardly “color by number.” Sponsors need to modify the document considerably to provide the reviewer with the information and clear view he/she requires.
With so much frustration and complexity growing around that second big question — the compliance question — Pinnacle 21 decided to step in and help.
On June 29, 2016, we published a white paper titled, “Preparing a Study Data Standardization Plan (SDSP),” authored by our VP of Clinical Data Services, Tom Guinter. Shortly afterward, on July 12, 2016, we hosted two live webinars on the same topic.
Below, you’ll find links to the webinar video and corresponding PPT deck. You’ll also find a link to the aforementioned white paper. These should serve as valuable resources to help get you up-to-speed on SDSPs.
If you have any questions pertaining to SDSPs, please don’t hesitate to send us an email.
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