Alliance SDC Updates

Jenny DarcyDirector, Alliance Data Management

CRP Information Session, November 2017

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)

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

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

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

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

DO NOT Access Rave Prior to Memorandum

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

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

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

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

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

Rave Task Summary

Data ManagementData Entry & Data Cleaning

l Example of Overdue Material Report

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

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

Questions?