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Name Size Creator Creation Date Last Modification Date Labels Attached To
PNG File Greg SA CF graphic (1).png 365 kB Kerry Robson Jan 30, 2023 10:51 Jan 30, 2023 10:51
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Page: Reimagining a Safety Submission – Aggregate Safety Assessment Planning
PNG File lauren.png 362 kB Lauren White Mar 21, 2024 16:00 Mar 21, 2024 16:00
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Page: Working Groups
PNG File image-2024-1-31_12-2-32.png 360 kB Alex Pearce Jan 31, 2024 12:02 Jan 31, 2024 12:02
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Page: Risk Based Quality Management
PNG File image-2024-1-31_12-2-32.png 360 kB Alex Pearce Jan 31, 2024 13:14 Jan 31, 2024 13:14
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Page: Working Groups
PNG File image-2024-6-25_10-45-54.png 360 kB Alex Pearce Jun 25, 2024 09:45 Jun 25, 2024 09:45
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Page: Centralised Monitoring Capabilities
PNG File image-2024-6-25_10-46-21.png 360 kB Alex Pearce Jun 25, 2024 09:46 Jun 25, 2024 09:46
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Page: Quality Tolerance Limits – Threshold Setting Methodologies
PNG File image-2024-6-25_10-46-9.png 360 kB Alex Pearce Jun 25, 2024 09:46 Jun 25, 2024 09:46
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Page: OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM
PNG File image-2024-6-25_10-44-19.png 360 kB Alex Pearce Jun 25, 2024 09:44 Jun 25, 2024 09:44
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Page: Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials
PNG File image-2024-1-31_12-2-32.png 360 kB Alex Pearce Jul 01, 2024 14:20 Jul 01, 2024 14:20
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Page: Working Groups Archive
Microsoft Word Document NSDRG_Completion_Guidelines_v1.2_finale8cbcbbf10e6… 358 kB Paula Apr 08, 2022 15:13 Apr 08, 2022 15:13
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Page: Nonclinical Study Data Reviewer's Guide (nSDRG) Package
Microsoft Word Document NSDRG_Completion_Guidelines_v1.2_finald5ae0e717bde… 358 kB Paula Apr 08, 2022 14:55 Apr 08, 2022 14:55
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Page: Nonclinical Study Data Reviewer's Guide (nSDRG) Package
Microsoft Word Document NSDRG_Completion_Guidelines_v1.2_final1aedcaad1d24… 358 kB Paula Apr 08, 2022 14:55 Apr 08, 2022 14:55
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Page: Nonclinical Study Data Reviewer's Guide (nSDRG) Package
PNG File image-2023-9-6_11-33-6.png 357 kB Alex Pearce Sep 06, 2023 10:33 Sep 06, 2023 10:33
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Page: Experiences with Adapting RWD to CDISC Submission Standards
PNG File DT quote 1.png 357 kB Lauren White Dec 10, 2020 12:20 Dec 10, 2020 12:20
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Page: Data Transparency Summer Event 2020 – Presentations and Resources
JPEG File Andy Richardson.jpg 357 kB Wendy Dobson Oct 27, 2020 15:17 Oct 27, 2020 15:17
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Page: Emerging Trends & Technologies
PNG File image-2023-9-6_11-32-15.png 357 kB Alex Pearce Sep 06, 2023 10:32 Sep 06, 2023 10:32
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Page: Experiences with Adapting RWD to CDISC Submission Standards
PNG File image-2022-9-20_10-0-22.png 355 kB Kerry Robson Mar 16, 2023 10:43 Mar 16, 2023 10:43
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Page: Data Transparency Winter Event 2023
PNG File image-2022-9-20_10-0-22.png 355 kB Kerry Robson Sep 20, 2022 11:00 Sep 20, 2022 11:00
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Page: Data Transparency Summer Event 2023
PNG File image-2023-8-4_12-19-0.png 354 kB Alex Pearce Aug 04, 2023 11:19 Aug 04, 2023 11:19
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Page: Safety Analytics Webinar Series: Overall Safety Assessment – AE Groupings for Assessment of Safety Topics of Interest
PNG File image-2023-8-4_12-19-0.png 354 kB Alex Pearce Sep 07, 2023 11:52 Sep 07, 2023 11:52
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Page: Safety Analytics Webinar Series: Overall Safety Assessment – Interactive Safety Graphics for Regulatory Decision-Making
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