Supplemental Checklist for the OPEN Rave Request Form

Supplemental Checklist for the OPEN Rave Request Form

This documentcontains a supplemental checklist (Table 1) for Lead Protocol Organization (LPO[1]) users, to help ensure that Rave set up, transactions are successfully transferred from OPEN to Rave, and all required testing is completed. The LPO’s Rave Administrator should complete this document for each Rave protocol. Please follow the “Instructions”specified in Table 1 to complete each checklist item. Questions with a red asterisk are required. This checklist should not be submitted to CTSU.

Table 1: Supplemental Checklist

Supplemental Checklist for Configuring Rave Protocols
Item # / Checklist Item / Completed? / Instructions
1* / Protocol Number / ☐Yes ☐ No / Provide the PIO assigned Protocol Number for the study. This can be located in the “Protocol #” field within the UAT or Production instance of RSS Oracle (within the “Protocol Maintenance” screen).
2* / Please confirm if the “Is Production” flag has been set up for the production version of the protocol? / ☐Yes ☐ No
[The checkbox for this field must be checked in iMedidata before study invitations are sent to users] / The “Is Production” flag is a configuration within iMedidata that is configured by the Rave contact for a study. The checkbox for this field must be checked in iMedidata (for the production version of the study) before Rave study invitations are sent to users.
3* / OPEN Eligibility Checklist (EC)form(s) and edit check set up complete in OPEN UAT? / ☐Yes ☐ No / Specify whether the setup of the protocol’s OPEN Eligibility Checklist (EC) form and edit checks are complete in the OPEN UAT environment.
4* / OPEN Standard Forms set up completed in Rave? / ☐Yes ☐ No / Specify whether the setup of the OPEN Standard Forms (Subject Enrollment, Demography, Step Information, and Treatment Information) in Rave is complete using the CTSU distributed ALS file.
5* / If OPEN will be used to push the EC data to Rave, was the EC form downloaded to Rave through the Rave OCI (Object Cart Importer)? / ☐Yes ☐ No ☐ N/A / Form should be added via the OCI from caDSR Formbuilder.
6 / If yes, is the EC “Rave-friendly”? / ☐Yes ☐ No ☐ N/A / To avoid errors when OPEN transfers EC data to Rave, certain guidelines need to be followed when designing a protocol’s EC form:
Click here for Guidelines for Pushing EC Data
7* / Was the test site CTSUTST01 linked to the protocol for auxiliary Rave environments? / ☐Yes ☐ No / Specify if the study was pushed to the site CTSUTST01 in the Rave UAT environment.
CTSUTST01 is a fictitious testing site that exists in iMedidata/Rave for testing use for the OPEN auxiliary environments, as well as for OPEN Production Practice mode. The site will not appear when queried in RSS or OPEN.
8* / Rave study draft published and pushed to “All Sites” in the Rave UAT environment? / ☐Yes ☐ No / Specify whether the study project draft was published to the CRF version, and was pushed to the Rave UAT environment for all site(s).
9* / Rave study draft published and pushed to “All Sites” in the Rave Production environment? / ☐Yes ☐ No / Specify whether the study project draft was published to the CRF version, and was pushed to the Rave Production environment for all approved sites.
10* / Was the Batch Upload role assigned to the RWS account in the Rave Production and auxiliary environment(s), for this protocol? / ☐Yes ☐ No / Specify whether Batch Upload role was granted to the Rave Web Service (RWS) account in the Rave Production and auxiliary environment(s) for the study.
11* / Testing completed for the Patient Initialization for the OPEN Standard Forms from OPEN UAT to Rave UAT for all steps that will be pushed to Rave? / ☐Yes ☐ No ☐ N/A
Date: Click here to enter a date. / Specify whether the testing was completed for the Patient Initialization and populating the four standard forms from OPEN UAT to Rave UAT for all steps that will be pushed to Rave. The date field refers to the date the testing was completed.
12 / If OPEN is used to push the EC data to Rave, was testing completed for transferring EC data from OPEN UAT to Rave UAT for all steps that will be pushed to Rave? / ☐Yes ☐ No ☐ N/A
Date: Click here to enter a date. / If OPEN is used for pushing the EC data to Rave, specify whether testing was completed for populating the EC data from OPEN UAT to Rave UAT for all steps that will be pushed to Rave. The date field refers to the date the testing was completed.
13 / Balance Testing / ☐Yes ☐ No / Confirm that patients are initialized in UAT in Rave for OPEN enrollments. Confirm the Balance question is checked and patient information is sent to Balance.
Confirm the correct treatment arm is returned to OPEN. Verify if the PID was randomized in Balance.
14 / If the protocol uses Rave-CTEP-AERS Integration, was the TAC/TAD sent to OPEN (as part randomization) using RandoNode? / ☐Yes ☐ No / As part the randomization process, the RandoNode should send the TAC/TAD to OPEN. During the patient initialization, OPEN will push this data to Rave. If Groups are initializing the patients in Rave, then the TAC and TAD should be pushed to Rave (Treatment assignment form) TAC/TAD are required in Rave for Rave-CTEP-AERS Integration.
15 / If protocol uses Rave-CTEP-AERS Integration, was testing completed to verify the rules evaluation by submitting data to CTEP-AERS from Rave? / ☐Yes ☐ No / Make sure that the patient is initialized in CTEP-AERS Beta and Rave UAT studies from OPEN UAT.
Enter data in the Adverse Event (AE) Form.
Make aRE call from ‘Expedited Reporting Evaluation (AER)’ form for a test patient in UAT environment to CTEP-AERS Beta (Group Rave URLs are configured to connect to CTEP-AERS Beta from UAT) to verify that CTEP-AERS recommendation is displaying correctly in ‘Expedited Reporting Evaluation (AER)’ form.
16 / Is the study using AIS-SAP Integration for TSDV based on-site auditing? / ☐Yes ☐ No / If yes, provide the study name to CTSU to setup the TSDV flag in RSS.
LPO should use Rave ALS version 5.2 or above. ALS 5.2 will add a question “Is the Subject identified for audit” to the “Patient Information NCI Reporting” form. AIS-SAP integration process populates this above question to “Yes” or “No”
Set up two "Field Rules” in TSDV Configuration to move the subjects between the two Tiers (No Forms and Audit Tier).
After the setup of TSDV “Field Rules” is complete, if audit question on “Patient Information for NCI Reporting” form is set to “Yes” the patient is movedinto the Audit tier in Rave so that TSDV can be captured. If it is set to “No” the patient is moved to the “No Forms” tier from “Audit tier” in Rave
After audit is scheduled in AIS, spot check the following in Rave/iMedidata:
1. The cross group auditors and volunteer auditors have been invited for studies where TSDV has been set up.
2. Auditable Patients show up in the “Requires Verification” under “Task Summary” in Rave.
After Audit is complete, spot check the following in Rave:
1. The Rave access has been revoked for group auditors and voluntary auditors.
2. Complete Audit Patients do not show up in the “Requires Verification” under “Task Summary” in Rave.
17 / Is the study using Central Monitoring (CM) Portal? / ☐Yes ☐ No / If yes, provide the study name to CTSU to setup the CM flag in RSS.
Select the appropriate patient selection criteria.
LPO should use Rave ALS version 6.0 or above. ALS 6.0 will add a question “Is the Subject identified for Central Monitoring review?” to the “Patient Information NCI Reporting” form. This question is automatically populated to “Yes” or “No” based on theCM patient selection criteria. If set to “Yes” the site will have to upload source documents to the CM Portal. If set to “No”, no source documents need to be uploaded.
Configure the instructions field on the “Central Monitoring” form to add study specific instructions for site users.
Configure the Custom Function (CF) in Rave to specify the selected Rave folders that contain data for CM review.
Verify that “Central Monitoring Alert” form rolls out in the study UAT environment in Rave in the expected folders
Verify that “Central Monitoring Alert” formdisplays a query.
18 / Is this an ePRO protocol? / ☐Yes ☐ No / If yes, provide the study name to CTSU to setup the ePRO flag in RSS. RSS will send invitations to the Patient Registration application.
If it is PRO CTCAE, use “PRO-CTCAE Version 1.0” ALS released by CTSU.
19 / CIP / ☐Yes ☐ No / CTSU-CIP-Rave Custom Function Setup Guide

Definitions for OPEN – Rave Integrations:

OPEN-Balance Integration:Medidata’s Cloud-based Randomization and Trial Supply Management Application that integrates with OPEN and Rave for patient randomization.

SAE Integration: Using Rave-CTEP-AERS. SAE integration links Ravefor reporting routine Adverse Events (AEs) with CTEP-AERS the system for the expedited reporting of SAEs. All routine AEs entered in Rave will be evaluated for possible expedited reporting, and if an expedited report is recommended, the user can launch CTEP-AERS directly from Rave in order to complete the reporting.

AIS-SAP Integration for TSDV based on-site auditing: A process where the site auditing activity is electronically tracked in Rave based on the configuration in TSDV that assignsthe patients to be audited to the auditing tier. The Site Audit Portal (SAP) integrated with CTEP’s Audit Information System (AIS) controls the auditable patients and the auditor access.

Central Monitoring (CM) Portal: A process for performing data monitoring remotely in Rave. Source documents are uploaded in the Central Monitoring (CM) Portal on the CTSU Website, a central location accessible to monitors to review against the data in Rave.

Data Quality Portal (DQP): DQP is accessible via the CTSU Website and provides access to query and form delinquency information for CTEP Rave studies, including the ability to link directly to Rave forms for management of data.

ePRO: Patient Cloud ePRO (electronic patient-reported outcomes) is the mobile app available for iOS and Android devices. Patients can report clinical trial information directly from their mobile devices into the Medidata Clinical Cloud.

CTSU Imaging Portal(CIP):CIP enables the site users to submit source documents to Rave via Fax. The site user will generate a barcoded coversheet from Rave and fax the documents along with the cover sheet to CTSU. CIP automatically loads the documents received via fax into Rave.

Supplemental Checklist for the OPEN Rave Request Form

Revision 3August 18, 2017Page 1 of 6

[1] LPO is used in this document to represent the lead organization for the protocol.