Form 78 CTSU OPEN RaveRegForm

CTSU OPEN Rave Request Form

OMB #xxxx-xxxx
Expiration Date: xx/xx/xxxx

Public reporting burden for this collection of information is estimated to average 5 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 many 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 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*

Protocol Name/Number:
(As specified by PIO)

e.g. E2410

Protocol Form Public ID(s):

1.2*

(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:

Click here to enter a date.
☐ 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

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

CTSU OPEN Rave Request Form
Revision 4 September 18, 2017

Page 1 of 4

SECTION I – Protocol and Request Information
1.8

If this Request is for a
Revision of the EC, Provide
the Revised CDE ID #s:

1.9*

Estimated OPEN Release
Date:

Click here to enter a date.

SECTION II – OPEN and RSS Setup Information
2.1*

Specify RandoNode URL:

e.g. https://webapps.ecog.org/RandoNode/services/RandoNode

2.2*

Indicate the Protocol
Type:
(Check one)

☐ Treatment ☐ Prevention

Reqd?

2.3*

2.4*

2.5

List the Protocol’s RSS
Step Information.
Select from the drop
down list of step
descriptions.

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

e.g. Yes

Count
Accrual
Step

Step #

e.g. 1

Step Description

Specify Rave Transactions
that OPEN will Handle:

(select one)

Patient
Initialization

Transfer EC
Data

☒

e.g. Yes

e.g. Yes

☐

Select or type.

☐

Select or type.

☐

Select or type.

☐

Select or type.

☐ Yes ☐ No

☐ Optional

2.6*

Is this a Slot Reservation
Protocol?

☐ Yes ☐ No

2.7*

Is this a Rave Protocol:

☐ Yes ☐ No

☐ Mandatory

(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:

e.g. ECOG-ACRIN

3.2*

URL of the Rave Instance
that will Host this Protocol:

e.g. https://ecog-acrin.mdsol.com

Rave Study Names:

PROD

e.g. E2410

3.3*

(Must match the protocol # in
RSS)

UAT

e.g. E2410 (UAT)

3.4*

OPEN-Rave ALS Version
Used for the Protocol?

CTSU OPEN Rave Request Form
Revision 4 September 18, 2017

☐ 4.0 ☐ 5.1/5.2 ☐ 6.0

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3.5

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 Balance
protocol?

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

4.2*

Is this a Rave-CTEPAERS 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? (CM
Flag)

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

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?

☐ Yes ☐ No

4.7*

Will this protocol use
CTSU imaging portal?

☐ Yes ☐ No

*This is required for all new CTEP IND trials

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)

CTSU OPEN Rave Request Form
Revision 4 September 18, 2017

Name: Click here to enter text.
Phone: Click here to enter text. E-Mail: Click here to enter text.

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SECTION VI – LPO Contact Information
6.2*

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

Name: Click here to enter text.
Phone: Click here to enter text. E-Mail: Click here to enter text.

LPO Sign Off:

6.3*

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: Click here to enter text.
Date: Click here to enter a date.

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
Revision 4 September 18, 2017

Click here to enter a date.

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