Industry SEND Progress Survey

From PhUSE Wiki
Jump to: navigation, search


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.

Project Overview

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.

Identified Need/Challenge

A recent set of questions that were exchanged from the Japanese SQA and the SQA GLP section, SEND Working Group highlighted the need to continue to actively communicate what the industry is doing to meet SEND requirements. The questions 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.

Vision

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.

Project Scope

Create an 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 requesting a 30 day response time. Compile the responses and distribute to PhUSE members and make the results available on the PhUSE WIKI.


Plans

Milestones

  • Project agreed by CS Steering Committee: TBD 2017
  • Schedule regular biweekly teleconfences
  • List of Survey questions: August 2017
  • Conduct Survey: October 2017
  • Analyze results: November 2017-December 2017
  • Publish result to WIKI and PhUSE CSS Annual Meeting Break Out Session: March 2018


Tasks

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. A presentation of data for Break Out session #2 at CSS 2016 is expected. The results will also be posted on PhUSE wiki.

Conference Calls and Minutes


File:Minutes 17-May-2018 PhUSE Survey Team notes 17-May-2018.pdf

File:Survey team minutes 21 June 2018.docx

File:2019.Survey.build.xlsx


File:Minutes 19July2018.docx

File:2019.Survey.build 19 July 2018.xlsx

Participation Needs

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:

  • Toxicologists
  • 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:

George Kalbaugh (george.kahlbaugh@boehringer-ingelheim.com)
Lou Ann Kramer (lou.ann.kramer@instem.com)
Bob Friedman (bfriedman@xybion.com)



Project Participants

Participants:
Bob Friedman, Xybion
George Kahlbaugh, Boehringer-Ingelheim
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

Survey development for 2016 (Work In progress)

PhUSE SEND Industry Survey 2016 ________________________________________ PhUSE SEND Industry Survey

Dear Responder,

Thank you for your time in responding to this survey and helping the industry as a whole know where we stand with SEND readiness. The responses to this survey are anonymous. The results of this survey are solely to develop a picture at a point in time of where the industry is with SEND implementation.

The Nonclinical Working Group of the PhUSE Computational Sciences Symposium

Note: Questions marked with a red asterisk means an entry is required.


What country are you located in?*


What is your primary job area?*

Scientist
Regulatory
Quality
IT
Other::  

________________________________________

1) Demographic: Is your organization primarily a (select all that apply):*

CRO
Sponsor
SEND Service Provider
Other (please describe):  *

________________________________________

Logic: Show/hide trigger exists. 2) Do you run studies in-house that will be submitted to FDA?*

Yes
No
Limited

Logic: Hidden unless: Question "Do you run studies in-house that will be submitted to FDA?" #2 is one of the following answers ("Yes","Limited") Please tell us what type of LIMS system(s) are you using to collect data for SEND datasets?


Logic: Hidden unless: Question "Do you run studies in-house that will be submitted to FDA?" #2 is one of the following answers ("Yes","Limited") For Nonclinical Drug Safety/ General Toxicology (select all that apply):*

In-house / custom
Commercially available system(s)/product(s)
Outsourced Service(s) to vendors or consultants (study conversions, training, etc.)
Other (please describe)::  *

Logic: Hidden unless: Question "Do you run studies in-house that will be submitted to FDA?" #2 is one of the following answers ("Yes","Limited") For DMPK and Analytical (select all that apply):*

In-house / custom system
Commercially available
Outsourced Service(s) to vendors or consultants (study conversions, training, etc.)
Other (please describe)::  *

Logic: Hidden unless: Question "Do you run studies in-house that will be submitted to FDA?" #2 is one of the following answers ("Yes","Limited") For Repro/DART (select all that apply):*

In-house / custom system
Commercially available
Outsourced Service(s) to vendors or consultants (study conversions, training, etc.)
Other (please describe)::  *

________________________________________


Logic: Show/hide trigger exists. 3) What stage of SEND readiness are you in? (select all that are appropriate)*

Have not started /education phase
Implementing a solution (in house, external services, systems)
Other::  *

Logic: Hidden unless: Question "What stage of SEND readiness are you in? (select all that are appropriate)" #3 is one of the following answers ("Implementing a solution (in house, external services, systems)") Please tell us about the system(s) you are implementing (select all that apply):

In-house software
Commercially available software
Commercially available software in a hosted (cloud) environment
External consultation services
Study conversion services
Other (please describe):  

________________________________________

Logic: Show/hide trigger exists. 4) What actions are you currently taking / have taken towards implementation? (select all that apply)*

Have provided training internally
Have performed dry runs of envisioned SEND process(es)
Already producing SEND datasets ("in production")
Have sent test dataset(s) to FDA
Have included SEND dataset(s) in an IND/NDA submission
Have exchanged SEND datasets with another organization
Other (please describe):  *

Logic: Hidden unless: Question "What actions are you currently taking / have taken towards implementation? (select all that apply)" #4 is one of the following answers ("Have exchanged SEND datasets with another organization") What was the purpose of the dataset exchange? (select all that apply)*

Internal reason (visualization, warehouse, etc.)
Regulatory submission or request
Other (please describe):  *

5) Are your service providers able to create SEND datasets or have a plan in place to do this in the right timeframe?

*
Yes
No
Need to confirm
Other (please describe):  *

Logic: Show/hide trigger exists. 6) With regard to your company's implementation of a SEND computer system(s), at what level do you intend to test the system?*

Validate/Qualify the system we use to generate SEND datasets internally
Perform testing of the system we use to generate SEND datasets but not at the Validation/Qualification level
We do not intend to test of the system we use to generate SEND datasets
Other (please describe or add additional information):  

Logic: Hidden unless: Question "With regard to your company's implementation of a SEND computer system(s), at what level do you intend to test the system?" #6 is one of the following answers ("Perform testing of the system we use to generate SEND datasets but not at the Validation/Qualification level") Please provide more information:


________________________________________ 7) At what point related to study finalization (report signed by Study Director) does your company plan to generate SEND datasets? (select all that apply)*

Prior to study finalization, for all studies
Prior to study finalization, upon sponsor/internal request (e.g. for data visualization purposes)
After study finalization, upon sponsor/internal request
After study finalization, for all studies
After study finalization, only if needed for a submission
Other (please describe):  *

8) What is the rationale for your timing decision in question #7 above? (describe)*


9) Will SEND datasets be used by the study director to interpret and analyze the data collected and to draw conclusions that are included in the final report?*

Yes
No
Certain occasions, when specified in the protocol
Not sure

________________________________________

10) How will your company provide QA oversight of the SEND dataset process?*

SEND datasets for each study will be audited as a study activity (audit included in QA Statement).
Each SEND dataset will be audited outside of the study (e.g., treated as facility audit, not included in QA Statement).
SEND dataset process will be audited (e.g., as a facility or process audit).
SEND dataset process is outside study activities and will not be audited.
Other (please explain):  *

11) How do you ensure that your datasets completely and accurately represent the study data? (Select all that apply.)*

100% QC of datasets
QC of datasets (less than 100%)
System testing/validation
Still undecided
Other (please describe):  *

12) What will you use as the reference source to verify (QC) your datasets against?

*
Verified against data tables generated from a LIMS collection system
Verified against the final report tables
Other (describe your source data as specifically as possible):  *

13) If applicable, are you ready to... Yes No Partially Not applicable Receive SEND dataset packages



Review SEND dataset packages



Analyze SEND dataset packages



Submit SEND dataset packages



________________________________________

Thank you for taking the time to complete this survey. If you have any additional remarks you would like to share, please use the space below.


________________________________________