Workbench
Welcome to the ICECAP Workbench (formerlly toolbox)! The workbench provides essential resources for study sites, covering regulatory documents, training materials, consent procedures, and reimbursement policies. This section includes key forms, checklists, and guidelines to support clinical teams in maintaining compliance and efficiency throughout the trial. Explore the categories below to access the materials you need.
Would you like a resource on this page that isn’t here? Please use the “submit a workbench request” button!
Electronic Informed Consent SOP (description of the central IRB-approved eConsent process)
All ICECAP sites should plan to use the electronic version of the consent form, with paper consent available as a last resort. The eConsent platform, Redcap, has been approved by the central IRB for eConsent use in ICECAP. A unique eConsent form link for your site will be provided to you after your site application has received central IRB approval.
IDE Approval Letter 6/9/16
Approval letter with conditions 4/29/16
Protocol and ICF Modification Approval Letter (May 2020)
Protocol Approval with Modifications Letter (January 2020)
Checklist (Please note your site manager will send you a site specific link once you are at that stage in the process)