Difference between revisions of "Interorganizational SEND"
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[[Category:FDA Working Groups]]
[[Category:FDA Working Groups]]
Revision as of 15:21, 30 May 2013
Interorganizational SEND Project
Welcome to the Wiki for our project to identify challenges and propose solutions to help Sponsors and CROs, to work efficiently together, in a world where nonclinical data, possibly derived from different organizations, will be required to be aggregated in SEND format, for submission to the FDA.
The responsibilities for creating the SEND files for a study is often shared across organizations. Clarity is needed on how these responsiblities can be effectively managed.
- We developed a framework to classify and prioritize scenarios in which data from multiple orginzations needs to be aggregated.
- We selected 3 scenarios and for each developed workfows "on-paper" to create and submit SEND datasets.
- While considering these scenarios we identified several questions that needed to be answered and collaberatively developed answers. These have been published on the PhUSE SEND User's Group wiki: Handling of SEND in Study Documentation
- We started preparing a Scenarios White Paper
- We published a poster at the 2013 FDA/PhUSE Computational Science Symposium
At the 2013 PhUSE/FDA conference we made the following plans:
- Test each of the work-flows presented at the 2013 conference by November with as close to real processes as possible and with 3 of the CROs participating in this working group
- Prepare a whitepaper/poster for 2014 FDA/PhUSE conference to share what we learned.
This table is being populated with the names of sponsor companies and the quarter of 2013 that will be testing the secnario with each CRO.
|Scenario 1: CRO Study with SEND Dataset Assembled by CRO||Sanofi q2-3||J&J q4||Lilly q2-3|
|Scenario 2: A CRO generating SEND with PK/TK data from outside||Sanofi, GSK||BMS q4||Lilly q2-3|
Scenarion 3 will be tested by INDS in Q2 and Roche in Q3.
The common Regulatory Data Flow will be tested by GSK and possibly others.
For each of these we are asking the respondent to answer the following questions:
- Does your experience match the scenario flow-chart?
- If not, where does it differ. Which way is better?
- If x happened instead of y, what was the impact? is there a recommendation from these differences.
- Do you have any experiences with re-work initiated by a request from the FDA. How long did the process take, What can you share about the experience?
- What were the challenges and solutions for them.
- What would you want to do differently in the future
- What would you need to work out in advance to ensure a smooth process
- Where there any areas that you were unable to resolve?
- how long did it take
- What were the actives that determined the length of the project (critical path).
- Do you have any guides on estimating the effort to do the work
- How many times have you done this? Is this the first experience?
- If you have done this several times, can you describe the learning curve?
- How long (calendar time, person hours) did each phase take? (determining what needs to be done, doing the work, confirming/closing the project)
- What tools (software) did you use?
In 2013 as we will contiue this work, we will need participation from individuals with the following areas of expertise with an interest and ideally gaining some experience exchanging data or reports with other organizations to contribute to this effort:
- IT Specilists
- SEND implementers
- GLP QA auditors
The total group will be limited to 12-20 people, with representation from all of the above areas of expertise.
What is the commitment?
- Time - will vary widely (minimum of 1 hour every two weeks for team meetings, up to 4-8 hours / month)
- Expected to contribute, not just be a spectator
If you would like to participate, please contact the co-leads for this group:
- Susan DeHaven (Susan.DeHaven@sanofi.com)
- William Houser (email@example.com)
1 telecon every other week at the same time. Since we have several new participants are in the process of selecting the best time.
- Pranav Agnihotri, PointCross
- Kenjie Amemiya, Genentech
- Kathryn Brown, Sanofi
- Susan DeHaven, Sanofi
- Steven Denham, MPI Research
- Jennifer Feldmann, Instem
- Jeff Foy, Celgene
- Geoff Ganem, Genentech
- Isaac Hatzell, Johnson & Johnson
- William Houser, Bristol-Myers Squibb
- Laura Kaufman, Preclinical Data Systems
- Jyotsna Kasturi, Johnson & Johnson
- Lou Ann Kramer, Eli Lilly
- Wayne Kung, Genentech
- Shree Nath, PointCross
- Louis Norton, Covance
- Debra Oetzman, Covance
- Gerard Randoph, Roche
- William Reinholt, MPI Research
- Lynda Sands, GlaxoSmithKline
- Troy Smyrnios, MPI Research
- Nathan VanSweden, MPI Research
- Audrey Walker, Charles River Laboratory
- Heather Williamson, PointCross
- Steven Wilson, MIP Research
- Peggy Zorn, INDS
Conference Calls and Minutes
Last revision by DanBoisvert,05/30/2013