Short Forms (New 10-7-20)
Clinical Team Resources (NEW 8-25-20)
DSMB Roster (coming soon)
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.
e-Consent Checklist (coming soon)
SIREN-NETT - FWA Requirements for Spokes
FWA Lookup: http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc
CLIA Lookup: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information.html
IDE Approval Letter 6/9/16
Approval letter with conditions 4/29/16
Protocol and ICF Modification Approval Letter (May 2020) (NEW 5-5-20)
Protocol Approval with Modifications Letter (January 2020)
Short Form Instructions (NEW 7-20-20)
Short Form Collection:
Readiness Checklist (coming soon)