Getting Started

 


POST-ICECAP Steps to be Released to Enroll

 

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

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

  1. Confirm WebDCU access if you don’t already have access to WebDCU by emailing POST-ICECAP-contact@umich.edu to request a WebDCU login.

 

  1. Complete the eDOA Log (electronic Delegation of Authority Log) 
    1. Once user permissions have been approved for a site team member, the team member can be added to the eDOA log. This is where the Primary Study Coordinator will select the role and responsibilities that each site team member has been delegated by the PI. The eDOA must be submitted for regulatory document requirements to populate for study team members.
    2. Please refer to the SIREN WebDCU User Manual for help with the eDOA.

 

 

  1. Upload Site Regulatory Documents and People Documents into WebDCU or transfer if existing in WebDCU for another trial

Please refer to the POST-ICECAP Regulatory Parameters Document for instructions for uploading Site Regulatory and People Documents. A complete list of required trainings based on role(s) and responsibilities is also found in the Document. 

  1. Complete Central IRB Tables in WebDCU

Please refer to the POST-ICECAP Regulatory Parameters Document page 12 for instructions on completing the cIRB tables.

  1. Review and verify or enter your “Site Overview” in the SIREN database.
  2. Review and verify or enter your “Site Inspection History” in the SIREN database.
  3. Enter your “Initial Site Submission” in the POST-ICECAP database.

 

  1. Request Ceding

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

  1. Provide the Protocol and Informed Consent to your local IRB, requesting they cede to Advarra for the POST-ICECAP Trial. Sequence of ceding steps are as follows:
  2. You will submit the consent with protocol to your IRB and request ceding for the POST-ICECAP study.
  3. You will need to provide documentation of your ceding request in WebDCU.

 

ICF Important Information! The cIRB approved POST-ICECAP ICF language is locked!

  • Please review the first page of the consent file for information on SIREN consents.
  • We are not accepting any changes or edits to the main body of the consent form.
  • If your IRB wants additional site-specific language that is non-duplicative with the main consent, they should provide the preferred language to you. Email site-specific language request to: POST-ICECAP-contact@umich.edu in a word document.
  • The CCC reviews and works collaboratively with you until any site-specific language is acceptable.
  • Upon cIRB approval, Advarra will add your site-specific language at the end of the consent in the “black box” section and site contact information will be populated on the consent form.

 

Important Information! Site Submission to Advarra is handled by the CCC!

  • Sites do NOT submit applications directly to Advarra. The CCC will submit site applications to Advarra once the site has completed all 3 cIRB tables and has a Ceding Acknowledgment Document uploaded to WebDCU.
  • Advarra will generate the final approved Informed Consent Form in English and Spanish upon site approval.
  • The CCC will then provide the eConsent link to your site after site IRB approval.

 

  1. Support timely execution of POST-ICECAP contract
    1. HUBs work with the University of Michigan and Spokes works with your HUB.

 

  1. Complete the Readiness Checklist
    1. Please work on the Readiness Checklist. When you are within a week of being ready, reach out to POST-ICECAP-contact@umich.edu to get on the calendar.

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