This document contains a supplemental checklist (Table 1) for Lead Protocol Organization (LPO) 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 specified in Table 1 to complete each checklist item. “Instructions” 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 Completed? Instructions Item # Checklist Item Yes No Provide the PIO assigned Protocol Number for the 1* This can be located in the #” field within the “Protocol Protocol Number UAT or Production instance of RSS Oracle (within the Maintenance” screen). “Protocol Yes No The Production” flag is a configuration within 2* “Is iMedidata that is configured by the Rave contact for a Please confirm if the Production” flag [The checkbox for this field must be “Is study. The checkbox for this field must be checked in has been set up for the production version checked in iMedidata before study of the protocol? iMedidata (for the production version of the study) invitations are sent to users] before Rave study invitations are sent to users. Specify whether the setup of the protocol’s OPEN OPEN Eligibility Checklist (EC) form(s) 3* and edit check set up complete in OPEN Yes No Eligibility Checklist (EC) form and edit checks are UAT? complete in the OPEN UAT environment. Specify whether the setup of the OPEN Standard Forms 4* OPEN Standard Forms set up completed (Subject Enrollment, Demography, Step Information, and Yes No in Rave? Treatment Information) in Rave is complete using the CTSU distributed ALS file. 5* If OPEN will be used to push the EC data Form should be added via the OCI from caDSR to Rave, was the EC form downloaded to Formbuilder. Yes No N/A Rave through the Rave OCI (Object Cart Importer)?
This document contains a supplemental checklist (Table 1) for Lead Protocol Organization (LPO) 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 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.