Attachment 18 Track Changes

CTSU OPEN Rave Request

OMB# 0925-0753
Expiration Date: 05/31/2024

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 ([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*
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_05.10.2023

Cancer Control/Prevention ☐ CCDR ☐
Step #

Registration Type

Choose an item.
Choose an item.
Choose an item.
Choose an item.
Choose an item.

Page 1 of 6

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

CTSU OPEN Rave Request Form_05.10.2023

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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:

2.1*

2.2*
2.3*

2.4

2.5*
2.6

Reqd?

Step #

e.g. Yes

e.g. 1

Step Description

Patient
Initialization

Transfer
EC Data

Non-Patient
Initialization

Transfer
NonPatient EC
Data

e.g. Yes

e.g. Yes

e.g. Yes

e.g. No

Specify Randonode URL
(if different from default
URL):
Is an Embedded
Ancillary Protocol
Associated with this
Protocol?
If Yes, Indicate
Whether the
Embedded Ancillary
Protocol is Optional or
Mandatory:
Is this a Slot
Reservation Protocol?
If Yes, Indicate the step
associated with Slot
Reservation

☐ Yes

☐ No

☐ Optional ☐ Mandatory

☐ Yes

☐ No

Step: _______

(Slot Reservation can only
be applied to one step)

2.7*

Is this a Rave Protocol:

☐ Yes ☐ No

2.8*

Will this protocol use
IROC credentialing?

☐ Yes ☐ No

(If No, skip to section V, only applies to legacy trials)

If yes, indicate each type of credentialing that will be collected in OPEN
(i.e. IMRT, 3D).
Type of Credentialing

Required

Choose an item.
Choose an item.
Choose an item.
CTSU OPEN Rave Request Form_05.10.2023

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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:

PROD

(Must match the protocol # in
RSS, e.g. E2410 or e.g.
E2410 (UAT))
OPEN-Rave ALS Version
Used for the Protocol?

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

Use the OPEN-Rave
Supplemental Checklist to
ensure the Rave
configurations and study
setup are completed
correctly.

CTSU-OPEN-Rave-RequestForm-SupplementalChecklist.docx

(Not for submission to the CTSU)

SECTION IV –Rave and RSS Setup Information

See the Supplemental Checklist for additional information regarding the integrations and the required testing.

4.1*

4.2*
4.3*

Is this a Rave-CTEP-AERS
Integration Protocol? (should
use the Standard CTSU AE,
AER, LAE and LAER forms)
(RSS caAERS Load Flag)
Does this protocol use
TSDV based on site
auditing? (TSDV Flag)
Will this trial be available on
the Data Quality Portal (DQP
Flag)

☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.1* or
above)
(This is required for all new CTEP IND trials)
☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.2* or
above)
(This is required for all new Rave trials)

☐ Yes ☐ No (If Yes, ☐ check if the study will not use Rave
calendaring)
Note: if Rave calendaring is not used, the DQP Delinquent Forms
and DQP Form Status modules will not be available
(This is required for all new Rave trials)
If yes, will this trial use the standard Phase 2/3 form timeliness
windows?*
☐ Yes ☐ No
*The standard Phase 2/3 form timeliness windows have been
defined by the Data Quality Working Group as 15 days for baseline
forms, 30 days for treatment forms, and 60 days for follow up forms.
A standard for Phase 1 trials has not been established; this form will
be updated with the standard Phase 1 form timeliness windows once

CTSU OPEN Rave Request Form_05.10.2023

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available.
If the trial will not use the standard Phase 2/3 form timeliness
windows, provide the timeliness windows below:
Baseline forms are delinquent

after days.

Treatment forms are delinquent

after days.

Follow up forms are delinquent after

days.

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

4.4*

Does this protocol use the
(This is required for select registration trials and trials as determined
source document portal for
Central Monitoring? (CM Flag) by CTEP)
(NCTN Groups may elect to
use the SDP for central
If yes, provide:
monitoring of trials as they see
Step Number:
appropriate.)

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: Choose an item.
Patient 1st X
or ‘Manual’ is selected.)

4.5*

What method will be used to
assign reviewable data points
in Rave?

Patient Next Y
‘All’ or ‘Manual’ is selected.)
☐ Rave architect

(Leave blank if ‘All’
(Leave blank if

☐ Dynamic data points/edit checks
☐ Rave architect and Dynamic data points/edit checks

4.6*

Does this protocol use the
source document portal for
Eligibility Review?

☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 6.0* or above)
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: Choose an item.

CTSU OPEN Rave Request Form_05.10.2023

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Patient 1st X
or ‘Manual’ is selected.)
Patient Next Y
or ‘Manual’ is selected.)
4.7*

Is this an ePRO protocol?

(Leave blank if ‘All’

(Leave blank if ‘All’

☐ Yes ☐ No

SECTION V – LPO Comments
5.1

Comments:
(Optional)

SECTION VI – LPO Contact Information
LPO OPEN Contact:

6.1*

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

6.2*

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

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

LPO Sign Off:

6.3*

The LPO ensures the
Name:
accuracy of this form and
that 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_05.10.2023

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