medidata rave and iwrs/open - national cancer institute · pdf filemedidata rave and iwrs/open...
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Medidata Rave and IWRS/OPEN
Early Drug Development MeetingApril 21 2013April 21, 2013
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Medidata Rave and IWRS/OPEN
AgendaAgendaRegistrationSl iSlot ReservationsCohort ManagementMedidata RaveData Submission GuidelinesData Submission GuidelinesTechnical Support
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Example Registration Flow
Registrar Logs into OPEN
ChooseEnroll
If last Slot taken, IWRS Notifies Sites of Closed
Cohorthttps://open.ctsu.org
Select site, protocol, investigator
TheradexIWRS Cohort Management
OPEN Verifies Slot Available and Cohort Open
Cohort
investigator
Enter demographic and eligibility checklist data
Management System
IWRS Marks Slot as Takeng y
Review & SubmitEnrollment Results:
as TakenLegendOPEN
IWRS
TheradexIWRS Registration
System
Enrollment Results:Patient ID
& Treatment Arm
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System
eCRFs
MedidataRave
Enrollment eCRFs
IWRS Populates Rave eCRFs
Example Theradex IWRS Slot Reservation Flow
R i t Cli k Ch Sl tRegistrar Clicks IWRS link in CTSU website
https://iwrs theradex com
Choose Slot Reservation
https://iwrs.theradex.comSelect site,
protocol, cohort
Click Reserve
IWRS Marks Slot
LegendCTSU.org
IWRSIWRS Marks Slot
as Reserved
Optional Features:
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• Slot Reservation Approvals• Reminders of Unused Reservations
Example Theradex IWRS Cohort Management Flow
L d I tit ti Ch C h t
g
Lead Institution Clicks IWRS link in CTSU website
https://iwrs theradex com
Choose Cohort Management
https://iwrs.theradex.comSelect protocol
Open, Close, or Expand Cohorts
LegendCTSU.org
IWRS
IWRS notifies Sites of Cohort change
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Quick and Easy Cohort Managementg
Open and Close Cohorts
Instant Email Notifications to Sites
Reserve Slots
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Medidata Rave
Web based EDC (electronic data collection) to be used in Web based EDC (electronic data collection) to be used in all future NCI studies
All ET-CTN studies will use the same standard TheradexAll ET CTN studies will use the same standard TheradexeCRFs resulting in expedited study set-up following approvalpp
Built-in, Real-time Edit Checks will minimize queries and after-the-fact data cleaning
Queries entered by CTMS monitors and auditors can be resolved within Rave by the site staff
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Medidata Rave Screenshot
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Data Submission Guidelines
All data is to be submitted within 2 weeks from when it All data is to be submitted within 2 weeks from when it becomes available to the site
Queries should be answered within 2 weeks of being Queries should be answered within 2 weeks of being issued
Task Summary makes it easy to track what tasks are Task Summary makes it easy to track what tasks are pending (e.g. non-conformant data, open queries, overdue data, etc.) for a study or a patient.
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End of Study Report
Theradex will create End of Study Report within 60 days Theradex will create End of Study Report within 60 days of last patient completing
End of Study Report will be used for Statistical analysis End of Study Report will be used for Statistical analysis, and have a sub-report with a subset of data.
Summary Reports for FDAAA Applicable Clinical Trials Summary Reports for FDAAA Applicable Clinical Trials (ACT)
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Technical Support
Theradex provides Rave User GuideTheradex provides Rave User GuideTheradex will provide support for IWRS and RaveCTSU will provide support for RSS and OPENCTSU will provide support for RSS and OPEN
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