Form 1 Form

CTSU OPEN Rave Request

OMB# 0925-0753
Expiration Date: 03/31/2026

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 sponsored,
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 7974, Bethesda, MD 20892-7974, ATTN: PRA (OMB#0925-0753). Do not return the completed form to
this address.

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 (CTSUOPENForms@westat.com). 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*
1.2*
1.3*

Protocol Name/Number:
(As specified by PIO, e.g.,
E2410)
Indicate the Protocol
Type
(Check one)
Protocol Form Public
ID(s):
(Please indicate the
associated step # for each
public ID)

1.4*

Protocol CRF Name:

1.5*

Protocol CRF Version #:

1.6*

LPO Name:

1.7*

Date of Request:

Treatment ☐
Public Form ID

CTSU OPEN Rave Request Form_06.18.2024

Cancer Control/Prevention ☐
Step #

CCDR ☐

Registration Type

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☐ New submission
☐ Addition of questions
☐ Deletion of questions
1.8*

Type of Modification:
(Check all that apply)

☐ 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
If this Request is for a
Revision of the EC,
1.9
Provide the Revised
CDE ID #s:
Estimated OPEN
1.10*
Release Date:
1 LPO is used in this document to represent the lead organization for the protocol

SECTION II – OPEN and RSS Setup Information
List the Protocol’s RSS Step Information. Select from the drop down list of step descriptions.

Specify Rave Transactions that OPEN will Handle:

Reqd?

Step #

2.1*

e.g. Yes

e.g. 1

2.2*

Specify Randonode URL
(if different from default
URL):

2.3*

2.4
2.5*

Is an Embedded
Ancillary Protocol
Associated with this
Protocol?
If Yes, Indicate Whether
the Embedded Ancillary
Protocol is Optional or
Mandatory:

Step Description

☐ Yes

Transfer EC
Data

Non-Patient
Initialization

Transfer NonPatient EC Data

e.g. Yes

e.g. Yes

e.g. Yes

e.g. No

☐ No

☐ Optional

Is this a Slot Reservation ☐ Yes
Protocol?

Patient
Initialization

☐ Mandatory

☐ No

CTSU OPEN Rave Request Form_06.18.2024

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2.6

If Yes, Indicate the step
Step: _______
associated with Slot
Reservation
(Slot Reservation can only be
applied to one step)

2.7*

Is this a Rave Protocol?

2.8*

Will this protocol collect ☐ Yes ☐ No
IROC credentialing in
If yes, indicate each type of credentialing that will be collected in OPEN (i.e.
OPEN?

☐ Yes

☐ No (If No, skip to section V)

IMRT, 3D).

Enter Type of Credentialing

Required

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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*

3.4*

3.5

Rave Study Names:
(Must match the protocol # in
RSS, e.g. E2410 or e.g.
E2410 (UAT))
OPEN-Rave ALS Version
Used for this Protocol:
Use the OPEN-Rave
Supplemental Checklist to
ensure the Rave
configurations and study
setup are completed
correctly.

PROD
UAT
☐ 4.0 ☐ 5.1/5.2 ☐ 6.0 ☐ 7.0 ☐ 7.1
(RN should be upgraded to support ALS 7.0 or higher)
CTSU-CDISC-CCDR RandoNode Setup

CTSU-OPEN-Rave-RequestForm-SupplementalChecklist.pdf

(Not for submission to the CTSU)

CTSU OPEN Rave Request Form_06.18.2024

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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 Rave-CTEP-AERS
☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.1* or
Integration Protocol? (Should
above)
use the Standard CTSU AE,
*(This is required for all new CTEP IND trials)
AER, LAE and LAER forms)
(RSS caAERS Load Flag)

4.2*

Does this protocol use TSDV
based on site auditing?
(TSDV Flag)

4.3*

Will this trial be available on
the Data Quality Portal (DQP
Flag)

☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.2* or
above)
*(This is required for all new Rave trials)
☐ Yes

☐ No

*(This is required for all new Rave trials)

If Yes, ☐ check if the study will not use Rave calendaring

Note: if Rave calendaring is not used, the DQP Delinquent Forms, DQP
Form Status modules and the DQP Timeliness Reports will not be
available.
4.4*

Does this protocol use the
source document portal for
Central Monitoring? (CM Flag)
(NCTN Groups may elect to use
the SDP for central monitoring
of trials as they see
appropriate.)

☐ Yes
above)

☐ No (If Yes, LPO should use Rave ALS version 6.0* or

*(This is required for select registration trials and trials as determined
by CTEP)
If yes, provide:
Step Number:
Please provide an effective date or check ‘Use protocol activation date’
Select Effective Date: Click or tap to enter a date.
OR, use protocol activation date: ☐
Patient Selection Method: Choose an item.
Patient 1st X
‘Manual’ is selected.)
Patient Next Y
or ‘Manual’ is selected.)

4.7*

Does this protocol use Patient
☐ Yes
Cloud ePRO?

(Leave blank if ‘All’ or
(Leave blank if ‘All’

☐ No

SECTION V – LPO Comments
5.1

Comments:
(Optional)

CTSU OPEN Rave Request Form_06.18.2024

Page 4 of 5

SECTION VI – LPO Contact Information
6.1*

6.2*

LPO OPEN Contact:
(The contact at the LPO for the
protocol’s OPEN configuration
questions)

Name:

LPO Rave Contact:

Name:

(The contact at the LPO for the
protocol’s Rave configuration
questions)

Phone:
E-Mail:
Phone:
E-Mail:

LPO Sign Off:

6.3*

The LPO ensures the
accuracy of this form and that Name:
all integration testing per the
supplemental checklist is
Date:
completed prior to study
activation in OPEN and Rave

SECTION VII – Form Download (To be Completed by CTSU)
7.1*

CTSU Reviewer Name:

7.2*

Date of Form Download:

CTSU OPEN Rave Request Form_06.18.2024

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