BACKGROUND

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:

Based on published guidance [See the Technical Rejection Criteria for Study Data at https://www.fda.gov/media/100743/download.] studies initiated after December 17, 2016, must be submitted with data formatted in accordance with the data standards listed in the FDA Data Standards Catalog for new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). For investigational new drug applications (INDs), the requirement [See the Technical Rejection Criteria for Study Data at https://www.fda.gov/media/100743/download.] applies to studies initiated after December 17, 2017. SEND 3.1 is included in the Data Standards Catalog, and the submission of SEND nonclinical datasets is expected to continue to increase in the future. This pilot will evaluate the compliance of sample SEND 3.1 datasets submitted to CDER. As part of this evaluation and in anticipation of FDA receiving datasets for regulatory review, the CDISC SEND team, in collaboration with CDER and available pilot participants, will update the SENDIG 3.1 as needed to include specific data elements and terms.

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.   

SHARED LEARNING

To meet the main tenet of shared learning from this pilot effort, the following deliverables are available:

1. The FDA Federal Register Notice, 84 FR 43139, announcing the pilot https://www.federalregister.gov/documents/2019/08/20/2019-17877/fit-for-use-pilot-program-invitation-for-the-clinical-data-interchange-standards-consortium-for (this link was tested at the time of posting but will not be maintained if revised in the future, please access the FDA Federal Register web page.)
   
   

2. INDUSTRY FEEDBACK Learning Points & Takeaways:       

   
   

3. 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
   
   

4. Submission packages provided by participants (each zip file comprises one participants contribution)

   participant 1.zipparticipant 4a.zipparticipant 4b.zipparticipant 5 (1).zip