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Date Name Thumbnail Size Description Versions
14:55, 2 January 2020 Nonclinical Study Data Reviewers Guide Completion Guidelines v1.2 draft.docx (file) 285 KB First version of 2020. Updated after nsdrg team meeting 2Jan2020. 1
14:53, 2 January 2020 SDRG Nonclinical Template V1.2 draft.docx (file) 62 KB First version of 2020. Updated after nsdrg team meeting on 2Jan2020. 1
14:44, 2 January 2020 SDRG Nonclinical Template V1.2 draft 02Jan2020.docx (file) 62 KB Template update following nsdrg team meeting on 2Jan2020. 1
11:01, 12 September 2019 Nonclinical Study Data Reviewers Guide Completion Guidelines v1.1.docx (file) 276 KB Draft working document - version following 9-12-2019 team meeting. Updating section 4. 4
14:45, 24 July 2019 Questions from PhUSE NSDRG Team on Section 5 10May2019 - FDA Response.pdf (file) 148 KB   1
10:44, 22 July 2019 2017 SEND Readiness Survey Results - Slides 11-20.pdf (file) 1.6 MB   1
10:41, 22 July 2019 2017 SEND Readiness Survey Results - Slides 1-10.pdf (file) 1.32 MB   1
10:30, 22 July 2019 CDISC PhUSE collaboration Kramer Decker Break out v1.pptx (file) 122 KB   1
10:27, 22 July 2019 DDSL 2017 CSS Overview.pptx (file) 1.65 MB   1
10:25, 22 July 2019 Opener - Nonclinical topics agenda.pptx (file) 510 KB   1
10:20, 22 July 2019 Breakout 1 Fit for Use Industry Feedback CSS preread.pptx (file) 850 KB   1
10:16, 22 July 2019 Breakout 1 - Data Inconsistency Methodology Findings and Goals Final.pptx (file) 558 KB   1
09:53, 19 June 2019 Challenges of SEND Implementation Status List.xlsx (file) 15 KB spelling correction 2
20:51, 18 June 2019 PhUSE CSS 2019 - SEND Workshop - BioCelerate Presentation Pack vF.pdf (file) 753 KB   1
15:24, 18 June 2019 Nonclinical Survey Results Slides CSS 2019.pdf (file) 677 KB   1
22:31, 2 June 2019 SEND Challenges Breakout Discussion.pptx (file) 121 KB   1
22:24, 2 June 2019 Nonclinical Scripts Project Status 2019.pptx (file) 688 KB   1
22:21, 2 June 2019 Data Visualization Project Status 2019.pptx (file) 717 KB   1
22:18, 2 June 2019 SEND Implementation User Group Status 2019.pptx (file) 694 KB   1
22:14, 2 June 2019 Data Consistency Project Status 2019.pptx (file) 1.16 MB   1
13:17, 13 May 2019 Getting Ready for 2019 CSS Nonclinical Topics Working Group.pdf (file) 185 KB   2
12:04, 10 May 2019 NSDRG Project Status 2019.pptx (file) 1.11 MB   1
12:03, 10 May 2019 Demystifying Define.xml Project Status 2019.pptx (file) 1.13 MB   1
12:02, 10 May 2019 2019 CSS Modeling ADA in Nonclinical studies Project Status.pptx (file) 1.17 MB   1
13:45, 16 April 2018 E-data Implementation Impact Panel Discussion Summary final.pptx (file) 537 KB   1
13:40, 16 April 2018 E-data Impact Panel Discussion - Nonclinical.docx (file) 537 KB   1
13:03, 16 April 2018 BO3 Improving Info Accessability - Wiki discussion outcome.pptx (file) 79 KB   1
12:49, 16 April 2018 PhUSE CSS 2018 BW Gain NonclinicalScript Presentation.pdf (file) 906 KB   1
12:47, 16 April 2018 SEND Development Status CDISC presentation CSS 2018.pdf (file) 203 KB   1
12:15, 16 April 2018 PhUSE-CSS-eTOX eTRANSAFE Presentation.pdf (file) 967 KB   1
12:09, 16 April 2018 PhUSE US CSS 2018 - BioCelerate Presentation - 2018-02-23.pdf (file) 904 KB   1
12:07, 16 April 2018 Data Consistency - SEND Datasets and Study Reports Wiki Deck.pdf (file) 227 KB   1
14:26, 12 April 2018 What can Do..... with Pic.pptx (file) 1.85 MB   1
14:19, 12 April 2018 PhUSE CSS 2018 Nonclinical Rosario Lilliam - flattened.pdf (file) 494 KB   1
13:59, 12 April 2018 Nonclinical WG photo CSS 2018 - web.jpg (file) 36 KB   1
10:36, 23 February 2018 NSDRG Project Status 2018.pptx (file) 1.2 MB   1
14:18, 10 November 2017 SDRG Nonclinical Template draft 09Nov2017.docx (file) 63 KB   1
06:56, 25 April 2017 CSS NonClinical Topics v2017 Lilliam Rosario OCS - keynote.pdf (file) 1.01 MB   1
06:42, 21 March 2017 2017 UPDATE Data Consistency to Reports.ppt (file) 405 KB   1
06:36, 21 March 2017 2017 UPDATE Nonclinical Script Assessment.ppt (file) 367 KB   1
21:18, 20 March 2017 2017 CSS NCT Breakout Plan.pptx (file) 502 KB   1
21:16, 20 March 2017 2017 UPDATE Visualization of Histopath Data.ppt (file) 370 KB   1
21:13, 20 March 2017 2017 UPDATE Test Submission Forum 2.ppt (file) 492 KB   1
21:11, 20 March 2017 2017 UPDATE nSDRG.ppt (file) 413 KB   1
21:09, 20 March 2017 2017 UPDATE Endpoint Modeling.ppt (file) 368 KB CSS update file 1
21:58, 18 March 2017 NSDRG Package v1.1 2017-03-19.zip (file) 513 KB nSDRG update to V1.1 for public. Update to Completion Guidelines and Template. 1
12:13, 16 March 2017 SDRG Nonclinical Guidelines update v1.1.docx (file) 304 KB Version 1.1. Updated with Public Comments and FDA comments from F4U. 1
14:34, 5 January 2017 Copy of Nonclin SDRG Public Comments Tracker.xlsx (file) 17 KB List of comments received by team. 1
14:12, 5 January 2017 SDRG Nonclinical Guidelines draft update from Public and FDA comments.docx (file) 366 KB Working Draft Version: Addressing comments from FDA FR Notice of Mar 2106 and associated Reviews and Pilots 1
13:53, 19 July 2016 20160525 Nonclinical Basel Resume.pptx (file) 572 KB Update for format corrections 2
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