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Project Scope

Across the Pharmaceutical Industry worldwide there is a variety of understanding of SEND and approaches to SEND implementation. Generally, the larger companies have had the resources to follow SEND through its first announcement to the issuance of the SEND Guidance document which set the due dates for SEND to be used for submission of the studies started on or after the due date.

This project creates an electronic survey sponsored by PHUSE, with up to 15 multiple choice questions and an option to provide additional free text information. The survey is sent out to PHUSE members, requesting a 30 day response time, then the responses are compiled, distributed and made publicly available

Execute a survey process to objectively collect data that enables detection of impactful issues and trends (both good and bad) that can be acted upon by the PHUSE community

The survey will:
- provide SDOs with actionable information regarding improvements to their standards.
- enable CROs, software developers and data service providers, with extensive data management experience, an opportunity to provide actionable recommendations
- provide Sponsors with information on how they can better leverage their SEND investments.




Project Leads

Email

Janice M Fiori 

fiori_janice_m@lilly.com

Lou Ann Kramer

lkramer@cdisc.org

Mike Harwood mike.harwood@instem.com
Lauren White (PHUSE Project Coordinator)lauren@phuse.global


Deliverables Timelines 

The team plans an annual survey with results to be published at the time of the PHUSE CSS. 

September 2021


Status
colourBlue
titleCurrent Status
 Q42020

Reviewing projects next steps after presenting at the virtual PHUSE/FDA CSS                                                                                  



Resources Type
2015 SEND Survey Results presented at the CSS 2016 event 
2016 SEND Survey Results presented at the CSS 2017 event 
2017 SEND Survey Results presented at the CSS 2018 event 
2018 SEND Survey Results presented at the CSS 2019 event 
2019 SEND Survey Results presented at the CSS 2020 event