Industry SEND Progress Survey
- 1 Project Overview
- 2 Plans
- 3 Participation Needs
- 4 Project Participants
- 5 SEND Survey Results 2017 (Presented at PhUSE CSS 2018)
- 6 SEND Survey Results 2016 (Presented at PhUSE CSS 2017)
- 7 2015 Survey Results (presented at PHUSE CSS 2016)
- 8 2017 March Survey Results
Welcome to the site for the Industry SEND Progress Survey project group.
This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on.
We are part of the FDA/PHUSE Computational Sciences Nonclinical Working Group.
Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.
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.
An annual survey continues to be informative to multiple stakeholders including PHUSE and CDISC and its members. Questions are asked about the timing of SEND dataset creation, the relationship between the report and the SEND datasets, and the decision to create SEND datasets for every study or to create the datasets only when a study is known to be in the submission.
Through responses to a survey, a picture of what is being done in the industry can be provided to all companies regardless of size and provide information for decision points. In addition, the agency can use the survey as a barometer of SEND understanding, process development, and need for additional guidance in general or specific areas. Results are presented at PHUSE CSS and/or PhUSE Connect meetings.
Create an annual electronic survey sponsored by PHUSE with up to 15 multiple choice questions with an option to provide additional free text information. Send that survey out to the PHUSE members (and CDISC list groups) requesting a 30 day response time. Compile the responses and distribute to PHUSE members and make the results available on the PHUSE WIKI.
- Survey Jan 2017
- Survey Jan 2018
- Survey Jan 2019
The project proposal is to create an electronic survey sponsored by the Nonclincal WG of PHUSE CSS collaboration. The survey would contain up to 15 multiple choice questions with an option to provide additional free text information. Send that survey out to the PHUSE members requesting a 30 day response time. Compile the responses and distribute to PHUSE members and make the results available on the PHUSE WIKI.
The areas to be covered by the questions would include but are not limited to:
- General progress to being SEND ready i.e. 25%, 50%, 75%, Complete
- Timing for SEND dataset creation i.e. at end of study or at time of submission
- Creation of SEND dataset for submission only or also for other data mining/visualization process/historical control
- Use of outside consultant or SEND software vendor to assist with implementation
- Involvement in the SEND project of support groups such as Quality Assurance
- Role of person signing to verify that data has been QC’d to the source data
- Estimate of additional resources needed to support/manage SEND
- Management of controlled terminology – implement every release or select releases
The project will need a suitable survey tool and a small team to support question development, support the survey, tabulate the results and distribute a report. The results will also be posted on PHUSE wiki.
Conference Calls and Minutes
Survey completed 17 Jan 2019 and mailed out on 18 Jan 2019.
The team was established following the PHUSE CSS March 2017.
Call for participation!
We have room for those interested in the status of SEND readiness across the industry and encourage individuals with the following areas of expertise to join and contribute to this effort:
- FDA reviewers
- IT vendors (with a special interest in the data quality aspect of SEND)
- Nonclinical data managers (with focus on the fitness for use aspect of SEND data)
- Biostatisticians (currently working or planning to work of SEND data)
What is the commitment?
- Time (minimum of 1 hour every two weeks for team meetings, up to 3 hours / month)
- Expected to contribute, not just be a spectator
- Contribution of viewpoints and content
- Wiki - creating/reviewing page content
If you would like to participate, please contact the co-leads for this group:
Lou Ann Kramer (firstname.lastname@example.org) Bob Friedman (email@example.com) Jance Fiori (firstname.lastname@example.org)
Bob Friedman, Xybion
Janice Fiori, Eli Lilly
Lou Ann Kramer, CDISC
SEND Survey Results 2017 (Presented at PhUSE CSS 2018)
Survey Results presented at the US CSS event, Silver Spring, March 2018
SEND Survey Results 2016 (Presented at PhUSE CSS 2017)
Survey Results presented at the US CSS event, Silver Spring, March 2017
2015 Survey Results (presented at PHUSE CSS 2016)
Survey Tool Output File With Results File:PhUSE SEND Survey - Final Results.pdf
2017 March Survey Results
Industry SEND Readiness Survey - 2017 Slide Deck