All content on this Wiki is non-binding and any individual opinions expressed should not be considered indicative of the policies or positions of CDISC or any other organization.
Welcome to the CDISC SEND Team's publicly accessible wiki page!
This page is primarily used to share the learning from Fit for Use (FFU, or usability) piloting done collaboratively with the FDA, Industry, and SEND; however, other materials are posted here when it is deemed useful to share publicly with the user community (e.g. results of surveys). Please check the left hand navigation pane or the list of links at the bottom of this page for ALL materials presented by the SEND Team to the public.
SEND Fit for Use Piloting
The CDISC SEND (Standard for Exchange of Nonclinical Data) team acknowledges the great value of usability testing of Implementation Guide (IG) releases and the direct benefit resulting from Fit-for-use (FFU) piloting on enhancing further development of the SEND standard. CDISC SEND Team has actively participated in FFU piloting with the FDA in the past (see the link in left hand panel to access the publicly-available results from the SENDIG v3.0 FFU pilot, a collaboration between CDISC, PhUSE, and the FDA).
One of the main tenets of a Fit for Use Pilot is that feedback provided to each participant and learning points gained by participating will be shared with the public broadly, via the CDISC and PhUSE organizations working processes. Learning from FFU piloting is expected to inform industry CDISC and PhUSE team efforts. (CDISC and PhUSE teams are open to all who are interested in volunteering on data standards and implementation team efforts.) Learning from the SENDIG v3.0 FFU pilot was also incorporated in version 3.3 of the FDA's Study Data Technical Conformance Guide.
Examples of the types of results that can be made shared publicly from a FFU pilot are listed below. The SENDIG v3.0 FFU pilot produced each of these (see link in panel to the left):
- Descriptions of, and charter for the SENDIG v3.0 FFU pilot
- FDA Challenges, Tabular examples
- Industry Feedback at a high level
- Industry Feedback at the Domain and Data file level
- Actual feedback from the FDA to individual sponsor participants about submission files (redacted)
All materials available on this wiki site:
- SENDIG-DART v1.1 Fit For Use Pilot
- SENDIG v3.1 Fit For Use Pilot
- SEND for CBER : Proof of Concept (public)
- SENDIG v3.0 FFU Results (public)
- Industry Responses to FDA Questions (April 2022 through October 2022)
Feedback on this wiki site can be left in the comments below.