Welcome to P-ICECAP! This page provides a step-by-step guide to help sites complete the necessary regulatory, training, and approval processes before enrolling participants. Here, you’ll find key information on CIRB reliance, WebDCU setup, training requirements, and site readiness milestones. Follow the outlined steps to ensure your site is fully prepared to participate in the trial. Click below to view the steps to be released to enroll in P-ICECAP!
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 2: Create Study Team Member Accounts in WebDCU (P-ICECAP)
Regardless of whether the study team member ever expects to access the P-ICECAP WebDCU database, each study team member must be added to WebDCU before the trial can start at the clinical site. The site P-ICECAP primary study coordinator has access to complete this step.
Step 3a: Create an eDOA Log (electronic Delegation of Authority Log) in WebDCU (ICECAP)
The site P-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.
Step 3b: Required Trainings for WebDCU and P-ICECAP using the Regulatory Parameters Document
Step 3c: Complete Regulatory Document Records in WebDCU
All team members MUST be added to the 1) P-ICECAP Database AND 2) the eDOA, BEFORE all regulatory documents can be fully displayed for completion, please see above.
P-ICECAP Site Milestone Document
Consent (Version 3)
- The CIRB approved ICECAP ICF language is locked. We are not accepting any changes or edits to the body of the consent form.
- There is a black box area on the consent where Advarra will add your local IRB site specific language after that language has been approved by study leadership. Language must not duplicate information already in the consent.
- Contact information and names for the site will be populated on the consent form by the CIRB when they approve the form.
Please see the SIREN SOP on relying on an external ER-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 P-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.
P-ICECAP Regulatory Parameters Document (Sites’ guide to regulatory, EFIC and cIRB submission field capture in WebDCU)
Please visit our Education and Training page for the complete list of trainings.
Contact: PICECAP-contact@umich.edu