Form 76 CTSU-OPEN Rave-Form

CTSU OPEN Rave Request Form

OMB# 0925-0753
Expiration Date: 07/31/2021

Public reporting burden for this collection of information is estimated to average 10 minutes per response,
including the time for review instructions, searching existing data sources, gathering and maintaining the
data needed, and completing and reviewing the collection of information. An agency man 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.

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)
Indicate the Protocol
Type
(Check one)
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:

CTSU OPEN Rave Request Form

e.g. E2410
Treatment ☐
Public Form ID

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
1.7*

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

1.8
1.9*
1 LPO

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

CTSU OPEN Rave Request Form

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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*

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

Select or type.
Select or type.
Select or type.
Select or type.
2.2*
2.3*

2.4

2.5*
2.6

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?

☐ Yes

☐ No

☐ Optional ☐ Mandatory

☐ Yes

If Yes, Indicate the step
associated with Slot
Reservation

☐ 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)

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:

PROD

e.g. E2410

(Must match the protocol # in
RSS)

UAT

e.g. E2410 (UAT)

CTSU OPEN Rave Request Form

Page 2 of 6

3.4*

3.5

OPEN-Rave ALS Version
Used for the Protocol?

☐4.0 ☐5.1/5.2 ☐6.0 ☐7.0 ☐7.1
*RN should be upgraded to support ALS 7.0
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*

Is this a Rave-CTEP-AERS
Integration Protocol? (should
☐ Yes ☐ No (If Yes, LPO should use Rave ALS version 5.1 or above)
use the Standard CTSU AE,
AER, LAE and
*This is required for all new CTEP IND trials
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)

4.4*

Does this protocol use the
source document portal for
Central Monitoring? (CM
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 ☐ Check if legacy study/Rave calendaring is not used

*This is required for all new Rave trials

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

CTSU OPEN Rave Request Form

(Leave blank if ‘All’
(Leave blank if

Page 3 of 6

4.5*

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.
Patient 1st X
or ‘Manual’ is selected.)

(Leave blank if ‘All’

Patient Next Y
or ‘Manual’ is selected.)

(Leave blank if ‘All’

SECTION V – LPO Comments
5.1

Comments:
(Optional)

SECTION VI – LPO Contact Information
6.1*

6.2*

LPO OPEN Contact:

Name:

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

Phone:

LPO Rave Contact:

Name:

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

Phone:

E-Mail:

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

CTSU OPEN Rave Request Form

Page 4 of 6

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

Page 5 of 6