Project Scope 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. |
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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 responsiblities 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 useCreate a "points to consider" listAdjust the template as neededPublish the results on the PhUSE SEND Wiki 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 Wiki and at the 2015 PhUSE/FDA Computational Sciences Symposium. |
Accomplished |
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Survey of industry SEND data from Small/Medium Service Providers: How prepared are they to supply data in SEND format?Template to Facilitate Creating Pharmacokinetic SEND datasetsFile:PC template with formulas.xlsx
Summaries of actual experience with scenarios Scenario ExperienceFile:MPI Research I-SEND Scenario Feedback 2013-05-03.docxFile:INDS Testing Scenario 3.docxFile:Scenario 1 w numbering.pdfFile:Scenario 2 w numbering.pdfFile:Scenario 3 w numbering.pdfFile:PP13 SEND Datasets for Interorganizational studies.pdfPoints to consider list when preparing to create SEND datasets for studies that involve multiple organizations:SEND_Implementation_Wiki_-_SEND_between_OrganizationsFile:PP08 Selecting a CRO for SEND.pdfThe role of GLP in SEND files http://www.phusewiki.org/wiki/images/d/d7/PP12_Quality_System_for_SEND_-_flat.pdf
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 DocumentationWe started preparing a Scenarios White PaperWe published a poster at the 2013 FDA/PhUSE Computational Science Symposium, which is available as slides File:I-SEND Poster 2013 as slides.pdf |