FAQ

No. The RRF is web-based. You can access it from any computer.

Yes. The RRF link can be used for all CRU Lab-Only studies (National Institutes of Health or Industry).

• Open the RRF link
• Complete the <General Information> section
• In the Facilities Research Visit Location section, select <UHCMC: CRU Lab Only>
• Select <No> for CRU Nursing Core Services
• Select <Yes> for CRU Lab Services
• Complete the CRU Lab Services section
• Select <No> for the remaining sections (Bionutrition, Informatics, etc)
• Upload your study documents to the application
• <Submit> your application

• Facilities
  • DCRU inpatient
  • DCRU/Coleman CRS outpatient
• Nursing services
• Lab services – sample processing, shipping or analytical services
• Bio-nutrition services
• Informatics (REDCap/Explorys)

You select only the Cores you need by checking the boxes marked • YES or • NO

Hint: To determine whether or not you need the services of a Core:

• In each service core section, select <YES> to view that Core’s services
• If you don’t need the services of that core, check the • NO box and move to the next core

There may be two distinct stages in the protocol implementation process:

Phase I: Contract and budget review: If you submit your CRU RRF, with at least the protocol, soon after your submission of documents to Grants & Contracts (G&C), we can work closely with the G&C and Research Finance Services teams to identify budget line items and speed the budget negotiation process.

Phase II: Protocol logistics and implementation: This phase of the implementation occurs most quickly if we have IRB-approved documents as our source documents. While we can begin the logistics and implementation processes without IRB-approved documents, final confirmation of protocol schema and lab processes (Lab Manual of Procedures – MOP) are usually not available until the Site Initiation Visit (for industry-sponsored trials), which can only occur after IRB approval.

• Protocol
• Clinical trials.gov number (CTN.gov)
• IND letter
• National enrollment information (if multicenter study)
• Lab manual/MOP
• IRB application (if available)
• IRB approval date (if available)

Name: Margaret (Peggy) Kelly
Core: Nursing
Email address: Margaret.Kelly@uhhospitals.org
Telephone: 216-844-4901

Name: Jillian Russell
Core: Nursing
Email address: Jillian.Russell@UHhospitals.org
Telephone: 216-286-3886

Name: Sarah Dawson
Core: Lab
Email address: Sarah.Dawson@uhhospitals.org
Telephone: 216-844-1579

Name: Alicia Thomas
Core: Bionutrition
Email address: Alicia.Thomas@uhhospitals.org
Telephone: 216-983-0887

Name: Karen Iacianci-Arian
Core: Finance
Email address: Karen.Iacianci-Arian@uhhospitals.org
Telephone: 216-844-4902

Name: Megan O’Neill Miller
Core: Administration
Email address: Megan.Miller3@uhhospitals.org
Telephone: 216-844-4720

Name: General Mailbox
Email address: DahmsCRU@uhhospitals.org
Telephone: 216-844-4902

Yes. Before you leave the session:
Click <Save and Return Later> at the bottom of any page of the RRF

• You will receive a RETURN CODE on the next screen.
• Write down that code.

When you are ready to return:

• Click on the same RRF link you used to start the resource request (it will open a new RRF)
• In the upper right of your screen, click on <RETURNING> button
• Enter your RETURN CODE
• Your original session will be restored. If it is not, email us at DahmsCRU@uhhospitals.org or call 216-844-4902 or 216-844-4720.

• Protocol (most recent version)
• Investigator’s Brochure
• IND or IDE approval letter (if applicable)
• IRB application
• IRB approval letter
• Consent/Assent forms
• Lab manual and/or MOP (if applicable)
• Pharmacy manual (if applicable)

Please note, for the fastest implementation service:

• Project should be IRB approved
• Upload AT LEAST the following documents with your RRF:
  • Protocol
  • Investigator’s Brochure
  • Lab Manual
  • IRB-approved consent form
• You do not have to wait for IRB approval to submit.
• Upload your unapproved documents to allow us to begin working on your protocol.
• When IRB approved, email your approved informed consent documents and the IRB approval letter.

Not a problem. At the very minimum, we need a copy of your close-to-final protocol to begin working on your project. It, along with all other documents, can be uploaded directly into the RRF or emailed to DahmsCRU@uhhospitals.org. In the subject heading of the email, include:

• PI’s last name, first initial
• Study short title
• The 4-digit “SPID” number in the survey response you receive after clicking <SUBMIT> on the application. This number is associated with only your study. Use it for all correspondence related to your study.

Please note, we will not be able to finish implementation until we have all the documents we need.

Yes. While it is preferred you upload the documents as part of the Resources Request Form, you can always email them to the CRU mailbox at DahmsCRU@uhhospitals.org. Be sure to Include PI last name, first initial and short protocol title in subject line. If you have received your CRU protocol number (ie D-1999), please include that.

Once in your CIRBI site:

• Under the yellow box on the left hand side of the study workspace, there is an activity called “Printer Version”.
• Click on that button
• Another page will open with the full submission with all responses and a list of documents.
• You can print then scan the document, or save it as a pdf and send to the DahmsCRU@uhhospitals.org mailbox.

All IRB software should allow you to download your completed application. Please contact that IRB office (Example: Reliant Review hub, Western Reserve, Cleveland Clinic) directly for download directions.

After the RRF has been electronically submitted you will not be able to access your original submission. However, if you need to make any changes please email DahmsCRU@uhhospitals.org or call 216-844-4902 and we will be more than happy to assist you.

Yes, within two business days an email acknowledgement will be sent to the person who completed the application. The email will include a pdf of your submitted application. The email may also ask for additional information.

Within two business days of submission, an acknowledgment email will be sent to the person who completed the RRF. Please either email the CRU at DahmsCRU@uhhospitals.org or call 216-844-4902 if you do not receive an acknowledgement email.

There is no mechanism to download a submitted RRF. But within two business days from submission of your request, you will receive a pdf version with your acknowledgement email.

All documents associated with a revision to the originally submitted protocol (IRB amendment application, revised protocol, IRB approval letter, informed consent documents, etc.) should be emailed to:

DahmsCRU@uhhospitals.org

In the email subject heading, include:

• PI last name, first initial
• CRU protocol number (i.e. D-1999)
• Short protocol title
• In the body of the email, a brief description of the changes is very helpful (i.e. additional PKs added, visit procedures modified, etc.)

We treat each request for CRU services as an opportunity to partner with you. Our role is to help you meet your recruitment goals, and to ensure the research subject experiences a pleasant research experience in a controlled, disciplined, quality-driven research environment. For us, protocol implementation is an interactive, collaborative process with your study team.

As a general rule, we strive to complete the protocol implementation work so the first patient can be seen within six weeks. But the timeline from “submission of CRU RRF” to “ability to see first patient” is dependent upon many factors:

• Are all the needed documents available to the CRU staff? [See FAQ: What documents should be submitted/uploaded with your application?]
• Is the protocol IRB-approved?
• The acuity level of the protocol (phlebotomy-only vs multi-arm multi-drug trial)
• How rapidly can we obtain responses to study logistics issues from the sponsor?
• (For industry-sponsored studies) Has the SIV been held?

And last but not least:

• Do you have research subjects waiting to be enrolled?

General steps in the CRU implementation process:

• Study team submits CRU RRF along with study documents
• Applicable CRU Managers, including Research Subject Advocate, will review the protocol NOT for content or scientific merit, but for many other factors, including feasibility for conducting the study on the CRU and participant safety issues. This review may result in request for additional information/clarification.
• CRU assigns a protocol nurse who will shepherd the study through the CRU implementation/first patient visit process
• CRU Protocol nurse will create study-specific physician orders and study source documents and submit to the study team for review and approval prior to the protocol conference
• Protocol conference: the goal is to hold a protocol conference within four weeks of receipt of the Resource Request Form and study documents (conference to include PI and key study team members. Conference satisfies GCP requirements for initial study team training and education)
• Resolution of outstanding issues/action items – usually through protocol nurse attendance at the SIV
• Physician approval of orders
• First patient