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Alliance SDC Updates
Jenny DarcyDirector, Alliance Data Management
CRP Information Session, November 2017
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Presentation Objectives• CALGB System Retirement Project
l Scope and Deliverablesl Timelinel Key Success Factorsl Questions and Discussions
• Terminated Studies• Central Monitoring • RAVE Task Summary/Delinquency Report/Data
Quality Portal (DQP)
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CALGB Systems Retirement Project
l Achieve the Alliance Statistics and Data Center (SDC) 2012 grant objectives to consolidate the legacy cooperative group systems and retire aging systems§ Move toward one data capture system - Rave
for Legacy CALGB studies by mid-January 2018
l Begin consolidation of legacy NCCTG trials built in Ingres data capture system to Rave in early 2018
l Terminate trials whenever scientifically reasonable
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Impact of Terminating Trialsl 20-30 trials have been terminated as part of
this initiativel Alliance SDC will no longer accept forms for these
trialsl Close terminated studies to your local IRB
l Do NOT close trials to the IRB prior to a termination notice
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What Can You Expect When Legacy Trials Transition to Rave?
l Notification memos posted on the Alliance and CTSU website
l All your data will be batch uploaded and viewable within Rave
l Rave invite from iMedidatal All future data collection and amendments
done through Rave
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When Can You Enter Data in Rave?
l When you receive the bi-monthly posting that states you may resume data submission for the studies listed
l New data submitted by Teleform will not be processed and will be returned to the site
l Prior to this broadcast message please abide by the warning when accessing Rave
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DO NOT Access Rave Prior to Memorandum
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ProposedTransitionDate
Study# Committee DataManager
10-1-2017 11001 Leukemia PamFainPribyl/JennyMentlick
10-1-2017 10801 Leukemia PamFainPribyl/JennyMentlick
10-1-2017 30406 Respiratory RyanPotaracke10-1-2017 80802 GI RyanPotaracke10-15-2017 80702 GI ChrisBryhn/Melissa
Heilman10-15-2017 140503 ThoracicSurgery TashaMcDevitt10-15-2017 50904 Lymphoma AndyJohnson11-1-2017 90203 GU GinaGrant11-1-2017 30901 Respiratory TashaMcDevitt11-1-2017 50303 Lymphoma KaylaDietzenbach11-1-2017 10701 Leukemia KaylaDietzenbach11-1-2017 10403 Leukemia KaylaDietzenbach11-15-2017 100104 Transplant AndyJohnson11-15-2017 90601 GU MistBova-Solem11-15-2017 11002 Leukemia KaylaDietzenbach11-15-2017 80803 GI SashaFord12-1-2017 50403 Lymphoma AndyJohnson12-01-2017 100701 Transplant KaylaDietzenbach12-01-2017 50803 Lymphoma AndyJohnson12-01-2017 40503 Breast SashaFord12-01-2017 49907 Breast SashaFord12-01-2017 40603 Breast MelissaHeilman12-15-2017 10603 Leukemia MistyBova-Solem12-15-2017 100801 Transplant KaylaDietzenbach12-15-2017 40601 Breast MelissaHeilman1-1-2018 30610 Respiratory AndyJohnson1-1-2018 50801 Lymphoma AndyJohnson
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Trials Requiring Your Help With Queries
l 80405 & 70807 – we need your help submitting data, so we can terminate these trials by December
l 80702 – the Data Manager will disregard all queries issued in Query Tracker – queries will requiring attention will be issued in Rave
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Central Monitoring Performed by the SDC
• Required Source Documentation Verification (SDV) in place for Ambassador (A031501) and Atomic (A021502)• Eligibility• Treatment (1st 2 cycles)• End Points
• Central Monitor will be required to document review of SDV in Rave
• Amended data breaks review flag and data will be re-reviewed
• Monitoring reports to be established
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l Expected and overdue materials (forms & queries) are tracked in numerous waysl Rave Task Summaryl Reports available to sites on Alliance websitel Data Quality Portal
Data ManagementData Entry & Data Cleaning
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Rave Task Summaryl Displays all pending tasks associated with
the study l High-level categories – status indicated by
iconl Non-conformant Datal Open Queriesl Overdue Data
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Rave Task Summary
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Data ManagementData Entry & Data Cleaning
l Example of Overdue Material Report
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Data Quality Portal (DQP)l DQP does not include Ingres studiesl Forms will stay on the DQP Delinquent
Forms tab if there is an outstanding system query
l DQP not yet available for sites – future tool
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Summary of Tools l Rave Task Summary – Patient-level reportl Delinquency/Overdue – Membership-level
report - includes all studies, regardless of the data capture systeml Currently doesn’t have the capacity for high-
accruing studies l Data Quality Portal (DQP) - Membership-
level report for studies in the Rave data capture system
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Questions?