SENDIG v3.1 Fit For Use Pilot is a collaborative effort, including FDA CDER Office of Computational Science (OCS), CDISC SEND development team, and industry participants. The call for participation was published via a Federal Register Notice (FRN) on 20-August-2019, 84 FR 43139 (see link below).
This pilot, as described in the FRN, was open to the public to apply for participation. An excerpt from the FRN follows:
One of the main tenets of an FDA Fit for Use Pilot is that feedback and learning by each pilot participant will be shared with the public broadly. This wiki site is made publicly accessible for that purpose and will be shared in multiple forums beginning in April of 2020.
Learning from this pilot is intended to inform industry improvement efforts and will be incorporated in the next major version of the SENDIG, currently named SENDIG v3.2.
To meet the main tenet of shared learning from this pilot effort, the following deliverables are available:
INDUSTRY FEEDBACK Learning Points & Takeaways:
Individual Participant Feedback - a powerpoint slide deck with details from each pilot participants experience.
This slide deck begins with a summarized description of the pilot content (study types and designs) and the following information on participation:
Agency sought maximum of 5 participants with selection based specific guidelines.
•Received Requests: 9
•Accepted Requests: 5
•Studies Evaluated: 7
Submission packages provided by participants (each zip file comprises one participants contribution)