Project Scope Welcome to |
Advance Hub 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. |
Need/Challenge |
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The responsibilities for creating the SEND files for a study is often shared across organizations. Clarity is needed on how these |
responsibilities can be effectively managed. |
Project Plans |
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At the March 2015 meeting:
Create a template for PP data and enhance the PP template to provide organizations without SEND capabilities a way to provide TK data in a format that can more easily be integrated into a set of SEND datasets for a study. Pilot its |
use. Create a "points to consider" |
list. Adjust the template as |
needed. Publish the results on the |
PHUSE SEND |
Advance Hub and at the 2015 |
PHUSE/FDA Computational Sciences Symposium. Evaluate the applicability of other CDISC standards CDASH, ADaM, ODM for non-clinical studies and publish the results on the |
PHUSE SEND |
Advance Hub and at the 2015 |
PHUSE/FDA Computational Sciences Symposium. |
Accomplished |
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Between March 2014 and March 2015
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Between March 2013 and March 2014 Summaries of actual experience |
with Scenario Experience |
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The role of GLP in SEND files |
Selecting a CRO for Creating and Integrating SEND Datasets from Multiple Organisations Between March 2012 and March 2013 We developed a framework to classify and prioritize scenarios |
ine 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 |
collaboratively developed answers. These have been published on the |
PHUSE SEND User's Group |
Advance Hub: 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, which is available as slides File:I-SEND Poster 2013 as slides.pdf |