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Page 1: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

Medidata Rave and IWRS/OPEN

Early Drug Development MeetingApril 21 2013April 21, 2013

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Page 2: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

Medidata Rave and IWRS/OPEN

AgendaAgendaRegistrationSl iSlot ReservationsCohort ManagementMedidata RaveData Submission GuidelinesData Submission GuidelinesTechnical Support

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Page 3: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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

Page 4: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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

Page 5: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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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Page 6: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

Quick and Easy Cohort Managementg

Open and Close Cohorts

Instant Email Notifications to Sites

Reserve Slots

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Page 7: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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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Page 8: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

Medidata Rave Screenshot

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Page 9: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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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Page 10: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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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Page 11: Medidata Rave and IWRS/OPEN - National Cancer Institute · PDF fileMedidata Rave and IWRS/OPEN Agenda Registration Slot Reservatiions Cohort Management Medidata Rave Data SubmissionSubmission

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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