Getting Started

  2. Getting Started

 

The Getting Started Process for ICECAP Spokes/Sites

Steps to Being Released to Enroll in ICECAP 

ER-CIRB: Resources and steps for relying on an external cIRB

  • Sites do NOT submit applications directly to Advarra. The Siren CCC will submit site applications to Advarra once the site has completed the “Initial Site Submission” in WebDCU under ICECAP - Central IRB.
  • Sites should be submitting requests to their local IRBs to cede to Advarra. The ceding request to the local IRB and the ceding acknowledgement from the local IRB both need to be uploaded and accepted to WebDCU prior to site applications being submitted.
  • Sites should also be working on uploading e-DOAs and other regulatory documents into WebDCU.

  • Sites must complete 3 tables in WebDCU for the Central IRB.

    • Start with the Site Overview table. Go to [SIREN] Icon in WebDCU – click on [Central IRB] – click on [Site Overview] to complete the table.
      • (If the table is already completed for your site, please review and email the site manager to verify that it correct).
    • Next, complete the Site Regulatory Inspection History table as needed; go to the [SIREN] icon in WebDCU – click on [Central IRB] – click on [Site Regulatory Inspection History].
      • You must complete a new record for each regulatory inspection for the Investigator or your research location(s) that have occurred in the last 5 years. If there are no inspections, you will need to attest that the site nor the investigator has had any reportable audits in the past 5 years.
    • Lastly, complete the Initial Site Submission table; go to the [ICECAP] icon in WebDCU – click on [Central IRB] – click on [Initial Site Submission] to complete. 
      • Please ensure that you have uploaded ALL of the regulatory and people documents to WebDCU BEFORE completing this table.

ICECAP Site Milestone Document 

Protocol 

Consent 

  • The CIRB approved ICECAP ICF language is locked.  We are not accepting any changes or edits to the body of the consent form.
  • Contact information and names for the site will be populated on the consent form by the CIRB when they approve the form.

WebDCU Resources 

Training

Training Resources:

Site Readiness 

 

ICECAP Study Team Members 

Step 1: Create a UM Friends Account (if you don't already have one)

New study team members need a UM Friend Account to access all of the ICECAP and Network trainings and resources. Click here for instructions on how to create one.

 

Step 2a: Review the ICECAP WebDCU User Account Process Guide 

Step 2b: Create Study Team Member Accounts in WebDCU (ICECAP)

Regardless of whether the study team member ever expects to access the ICECAP WebDCU database, each study team member must be added to WebDCU before the trial can start at the clinical site. The site/spoke ICECAP primary study coordinator has access to complete this step.

Please refer to the ICECAP WebDCU User Account Process Guide.

 

Step 3a: Create an eDOA Log (electronic Delegation of Authority Log) in WebDCU (ICECAP)

The site/spoke ICECAP primary study coordinator or PI will have access to complete this step. Select the role and responsibilities that each site team member has been delegated to by the PI. The eDOA must be submitted in order for regulatory document requirements to populate for study team members.

Please refer to the ICECAP WebDCU User Account Process Guide.

Step 3b: Required Trainings for WebDCU and ICECAP using the Regulatory Parameters Document 

Step 3c: Complete Regulatory Document Records in WebDCU

All team members MUST be added to the 1) ICECAP Database AND 2) the eDOA, BEFORE all regulatory documents can be fully displayed for completion, please see above. 

 

General Study Start-Up and Regulatory Assistance

Contact: ICECAP-contact@umich.edu or (734) 232-2142 to reach a Site Manager.

 

Bookmarks

Bookmark these most commonly referenced SIREN-NETT-affiliated websites:

​SIREN

WebDCU

ICECAP

SIREN Standard Operating Procedures

 

Are you a SIREN-affiliated Hub bringing up an ICECAP Spoke?

Consult the Hub Management of Spokes SOP.

The Hub is responsible for making sure all the spoke tasks are met. However, the Hub can tailor the process to meet their Hub/Spoke Complex relationship in accordance with the Hub/Spoke Complex SOP.

Please note: If your Hub will be an actively enrolling site, it will be considered a spoke in the WebDCU regulatory and study databases. Instructions for spokes below would then apply to the Hub as well.

 

Are you an ancillary ICECAP Hub?

You will also be considered a spoke in the WebDCU regulatory and study databases. Instructions for spokes below apply.
 
 
Are you a ICECAP Spoke?
  • Enter all spoke study team members into the WebDCU ICECAP database for their roles in ICECAP in the Study Spoke Team Member Request table. You will not be ready to upload documents for team members until this occurs.
  • While preparing your site CIRB application, People and Spoke regulatory documentation should be entered into the WebDCU study database per the ICECAP Regulatory Parameters Document. The goal is to be ready to enroll, including being regulatory and training compliant as documented in WebDCU, prior to study CIRB approval. Please check with your Hub contact to confirm what your Hub/Spoke complex process will be for documenting and maintaining regulatory compliance in the WebDCU study database.
  • When you are regulatory ready, the Hub should then contact their SIREN Site Manager for ICECAP, to schedule a readiness call.