CTSU-OPEN -Rave Form RevisedMarked-up Attach 18

Corrected time in burden statement from 5 to 10 minutes per SSA

Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7074, Bethesda, MD 20892-7974, ATTN: PRA (OMB#0925-0753). Do not return the completed form to this address.

OMB# 0925-0753

Expiration Date: 07/31/2021

CTSU OPEN Rave Request Form

Use this form to initiate the development of a new protocol in OPEN and Rave, or to update an Eligibility Checklist for an existing protocol.

Submit the completed form to the OPEN Registrar team ([email protected]). Please contact the OPEN team for any questions regarding the form. All questions marked with a red asterisk (*) must be completed.

For Rave protocols, an individual from the Lead Protocol Organization (LPO)¹ must notify CTSU of the Rave production release date to configure the Rave production settings.

SECTION I – Protocol and Request Information
1.1*	Protocol Name/Number: (As specified by PIO)
1.2*	Protocol Form Public ID(s): (Please indicate the associated step # for each public ID)
1.3*	Protocol CRF Name:
1.4*	Protocol CRF Version #:
1.5*	LPO Name:
1.6*	Date of Request:
1.7*	Type of Modification: (Check all that apply)	☐ New submission ☐ Addition of questions ☐ Deletion of questions ☐ Question setup changes (such as data type, question order, help text) ☐ Major wording changes (impacts responses) ☐ Minor wording changes to questions (does not impact responses) ☐ Change in valid values (addition, deletion, update) ☐ Updates to the Rave information ☐ Edit check updates
1.8	If this Request is for a Revision of the EC, Provide the Revised CDE ID #s:
1.9*	Estimated OPEN Release Date:

SECTION II – OPEN and RSS Setup Information
2.1	Specify RandoNode URL:	Remove Question e.g https://webapps.ecog.org/RandoNode/services /RandoNode
2.1*	Indicate the Protocol Type: (Check one)	☐ Treatment ☐ Prevention
2.2*	List the Protocol’s RSS Step Information. Select from the drop down list of step descriptions.	Reqd? e.g. Yes	Count Accrual Step	Step #	Step Description	Specify Rave Transactions that OPEN will Handle:
						Patient Initialization	Transfer EC Data
				e.g. 1		e.g. Yes	e.g. Yes
		Remove this column
2.3*	Is an Embedded Ancillary Protocol Associated with this Protocol?	☐ Yes ☐ No
2.4	If Yes, Indicate Whether the Embedded Ancillary Protocol is Optional or Mandatory:	☐ Optional ☐ Mandatory
2.5*	Is this a Slot Reservation Protocol?	☐ Yes ☐ No
2.6*	Is this a Rave Protocol:	☐ Yes ☐ No (If No, skip to section V, only applies to legacy trials)

Remove question

SECTION III – Rave Information
3.1*	Name of the Rave Instance that will Host this Protocol:
3.2*	URL of the Rave Instance that will Host this Protocol:
3.3*	Rave Study Names: (Must match the protocol # in RSS)	PROD
		UAT
3.4*	OPEN-Rave ALS Version Used for the Protocol?	☐ 4.0 ☐ 5.1/5.2 ☐ 6.0 ☐ 7.0
3.5	Use the OPEN-Rave Supplemental Checklist to ensure the Rave configurations and study setup are completed correctly. (Not for submission to the CTSU)	CTSU-OPEN-Rave-RequestForm-SupplementalChecklist.docx

SECTION IV –Rave and RSS Setup Information See the Supplemental Checklist for additional information regarding the integrations and the required testing.
4.1*	Is this a Balance protocol?	☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 6.0* or above)
4.2*	Is this a Rave-CTEP-AERS Integration Protocol? (should use the Standard CTSU AE, AER, LAE and LAER forms) (RSS caAERS Load Flag)	☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.1 or above) *This is required for all new CTEP IND trials
4.3*	Does this protocol use TSDV based on site auditing? (TSDV Flag)	☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.2* or above) *This is required for all new Rave trials
4.4*	Does this protocol use central monitoring the source document portal for central monitoring? (CM Flag) Add section below line on right Rephrased question 4.4 when the CM portal was renamed Source Document Portal.	☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 6.0* or above) *This is required for all new CTEP IND trials
		If yes, provide: Step Number: If this is Not a new activation, enter effective date, otherwise leave blank: Select Effective Date: Click or tap to enter a date. OR, use protocol activation date: ☒ Patient Selection Method: Patient 1st X (Leave blank if ‘All’ or Manual is selected) Patient Next Y (Leave blank if ‘All’ or Manual is selected)
4.5*	Will this trial be available on the Data Quality Portal (DQP Flag)	☐ Yes ☐ No *This is required for all new Rave trials
4.6*	Is this an ePRO protocol?	Remove question ☐ Yes ☐ No
4.7*	Will this protocol use the CTSU Imaging Portal	☐ Yes ☐ No

SECTION V – LPO Comments
5.1	Comments: (Optional)

SECTION VI – LPO Contact Information
6.1*	LPO OPEN Contact: (The contact at the LPO for the protocol’s OPEN configuration questions)	Name: Phone: E-Mail:
6.2*	LPO Rave Contact: (The contact at the LPO for the protocol’s Rave configuration questions)	Name: Phone: E-Mail:
6.3*	LPO Sign Off: The LPO ensures the accuracy of this form and that all integration testing per the supplemental checklist is completed prior to study activation in OPEN and Rave	Name: Date:

SECTION VII – Form Download (To be Completed by CTSU)
7.1*	CTSU Reviewer Name:
7.2*	Date of Form Download:

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

CTSU OPEN Rave Request Form

June 17, 2019 Page 4 of 4