ACRIN 6701 Repeatability Assessment of Quantitative DCE- MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate Data Management Training Glenna Gabrielli, Senior Research Associate

ACRIN 6701 Study Chair: -Mark Rosen, MD, PhD Co-Chair- Physicist -Edward F. Jackson, PhD Study Statistician -Eunhee Kim, PhD

ACRIN 6701 Donna Hartfeil, Project Manager Glenna Gabrielli, Data Manager Dena Flamini, Imaging Technologist

ACRIN 6701 Patty Blair, Monitoring Chris Steward, Auditing

Registration/OPEN -Accessing OPEN -Registering a Patient Data Collection/MedidataRave Medidata Rave -Setting up your Rave account - eLearnings -iMedidata v. Rave EDC -ACRIN 6701 in Rave -General Rave EDC Overview

Registration/OPEN

Accessing OPEN

All site staff (Lead Group) will use OPEN to enroll patients to this study. OPEN can be accessed at ( or from the CTSU members' web site OPEN tab. Prior to accessing OPEN site staff should verify the following: All eligibility criteria have been met within the protocol stated timeframes. Site staff should use the registration forms provided on the group or CTSU web site as a tool to verify eligibility. All patients have signed an appropriate consent form and HIPAA authorization form (if applicable). Access requirements for OPEN: Site staff will need to be registered with CTEP and have a valid and active CTEP-IAM account. This is the same account (user id and password) used for the CTSU members' web site. If you do not have one you can log into ctep.nci.nih.gov/iam and request an account. {Please allow 3 business days for processing.} To perform registrations, the site user must have been assigned the 'Registrar' role on the relevant Group or CTSU roster. To perform registrations on protocols for which you are a member of the Lead Group, you must have an equivalent 'Registrar' role on the Lead Group roster. Role assignments are handled through the Groups in which you are a member. To perform registrations to trials accessed via the CTSU mechanism (i.e., non-Lead Group registrations) you must have the role of Registrar on the CTSU roster. Site and/or Data Administrators can manage CTSU roster roles via the new Site Roles maintenance feature under RSS on the CTSU members' web site. This will allow them to assign staff the "Registrar" role.

Accessing OPEN Upon patient registration to the ACRIN 6701 trial through OPEN (Oncology Patient Enrollment Network) via an electronic copy of the registration /eligibility data will be available in Medidata Rave. Further instructional information is provided on the CTSU members' web site OPEN tab or within the OPEN URL. For any additional questions contact the CTSU Help Desk at or

Registering a Patient in OPEN

Data Collection/Medidata Rave

Data collection for this study will be done exclusively through Medidata Rave. Access to the trial in Rave is granted through the iMedidata application to all persons with the appropriate roles in RSS. To access iMedidata/Rave the site user must have an active CTEP IAM account ( Upon initial site registration approval for the study in RSS, all persons with Rave roles assigned on the appropriate roster will be sent a study invitation from iMedidata. To accept the invitation, site users must log into the Select Login ( using their CTEP-IAM user name and password, and click on the “accept” link in the upper right-corner of the iMedidata page. Please note, site users will not be able to access the study in Rave until all required Medidata and study specific trainings are completed. Trainings will be listed in the upper right pane of the iMedidata screen. Users that have not previously activated their iMedidata/Rave accounts will also receive a separate invitation from iMedidata to activate their account. Account activation instructions are located on the CTSU website, Rave tab under the Rave resource materials (Medidata Account Activation and Study Invitation Acceptance). Additional information on iMedidata/Rave is available on the CTSU website under the Rave tab at Please refer to the ACRIN 6701 Forms Completion Guidelines for the forms submission schedule. The investigative site is required to submit data according to protocol. The case is closed when all data have been received, reviewed, and no outstanding data query exists for the case. If a temporary problem prevents access to the URL, all sites are notified of the event and estimated down time. The investigative site should wait until access is restored to submit data. The site research associate (RA) or investigator should notify the DMC of the problem and the DMC will give an estimated time when access will be restored, as well as instructions for sites to proceed in the interim.

Medidata Rave

Setting up your Rave account

In order to set up your account, follow the instructions in the invitation from: Check your junk box if you do not receive it. Please remember the user name and password you specify- it will be required at each login and for future access to iMedidata and Rave

eLearnings

Required and Optional eLearnings Required These eLearning's must be taken in order to gain access to EDC Rave 5.6 EDC Essentials for Clinical Research Coordinators (~45min) ECOG-ACRIN Supplemental eLearning (~10min) Optional Data Privacy Considerations for Clinical Systems (~50min) EDC Inspection Readiness for Clinical Sites (~30min) Access to assigned eLearning's

iMedidata v. Rave EDC

iMedidata v. Rave iMedidata is the user portal- you can access all Medidata Rave URLs you have permissions to from here Rave is the URL where the database is built and managed You will always sign in through iMedidata – Note: If you have an existing CTEP IAM account, you can also sign in through the CTSU portal

Logging In: To access the study in Medidata Rave (hereafter “Rave”), you will need to log-in to iMedidata Enter your username and password, then click the “Log in” button

Accessing the study: Once logged into the iMedidata portal select the “Rave EDC” option for the study. Depending on how many studies you have access to you may need to click the “Next” button to go through the study listing OR search for your study in the search box. OR OR

ACRIN 6701 in Rave

After the case is registered via OPEN -Sign into iMediata using your user name and password

Select Rave EDC under ACRIN 6701 from your list of studies

ACRIN 6701 Rave EDC Homepage

Subjects Home Page

Icon Key Available on Each Page

General ACRIN 6701 Rave Layout Folders are titled by time point and form types – Folders appear on the patient page in the order they should be completed Most forms are contained in folders – Forms appear in the folders in the order they should be completed – Folders/Forms are rolled out according to data entered in the existing forms

Initial Folders Enrollment Forms Contains registration (A0) data. All forms are read- only Surgical History Contains form to capture TRUS biopsy data MRI Scan 1 Visit Contains forms to capture data for MRI 1 visit MRI Scan 2 Visit Contains forms to capture data for MRI 2 visit End of Study Adverse Events Protocol Deviation

Enrollment Forms The Enrollment Forms Folder is where the entered A0 data is available The primary form is the subject enrollment form. This form contains administrative data related to registration (case number, site #, enrollment date, etc…)

Click on a folder to see the forms

Enrollment Forms All data in the enrollment forms folder and on the subject enrollment form is read only.

MRI Scan 1 and 2 Visit Forms Imaging Procedure MRI Scan Administration MRI Imaging Assessment-Anatomic MRI Imaging Assessment-DWI DCE MRI Repeat Image Trigger Image Transmittal Worksheet AE Follow up Safety Assessment Form Baseline Abnormalities 2

General Rave EDC

Dynamic Fields and Forms Rave has the functionality to add fields/forms dynamically to a form/folder/subject All fields that trigger a dynamic function are in italics and appear in either blue or purple font Blue font means the field triggers another field to appear on the form Purple font means the field triggers another form to appear Note: Purple font may also mean that another field and folder are triggered All Forms in the folder are required and can be considered complete when they have the icon For example: The first time the Imaging Procedure Form is opened, only one question appears

Dynamic Fields and Forms Initial View of Imaging Procedure Form

Dynamic Fields and Forms View after “Did imaging commence” answered Yes

Queries Queries will appear when a mandatory field is missing, a field is out of range, or if a field is not compliant with other forms Queries appear after the form is saved as a red highlighted box with the icon The query viewable below the question If the data is revised, the reason for revision must be provided The form will appear with the query icon until the query has been resolved The response field is not required unless the data is correct as is The response field will be greyed out once the data is changed/provided If data is correct as is and a response is provided, the field will still appear highlighted in red, but will have the answered query icon Query Response field Reason for Revision options

Questions?