Clinical Site Progress Report - September 4, 2020
The site progress report as of September 4, 2020, indicates significant progress in the clinical trial process. 41 sites have received Advarra approval, 36 sites have completed their readiness call, and 29 sites have executed contracts. 22 sites are released to enroll, with Ben Taub General Hospital, Houston, TX, and Cedars-Sinai Medical Center, Los Angeles, CA, among those sites. The report also shows 14 sites currently in the screening phase and 14 sites with enrolled participants. The document includes detailed information on sites with executed contracts and those released to enroll, highlighting the status and readiness of each.
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C3PO 4 September 2020
Site Progress 41 Sites have Advarra approval 36 Sites have completed their readiness call 29 executed contracts 22 Released to Enroll 14 sites Screening 14 Enrolled
29 Sites With Executed Contracts Name Ben Taub General Hospital, Houston, TX Cedars-Sinai Medical Center, Los Angeles, CA Detroit Receiving Hospital, Detroit, MI Grady Memorial Hospital, Atlanta, GA Harbor-UCLA Medical Center, Torrance, CA Harper University Hospital, Detroit, MI HealthPartners Methodist Hospital, St. Louis Park, MN Henry Ford Hospital, Detroit, MI Jackson Memorial Hospital, Miami, FL Memorial Hermann Texas Medical Center, Houston, TX Oregon Health & Science University Hospital, Portland, OR OSU Wexner Medical Center, Columbus, OH Regions Hospital, St Paul, MN Sinai-Grace Hospital, Detroit, MI Spectrum Health Hospitals Butterworth Hospital, Grand Rapids, MI Stanford University Medical Center, Stanford, CA Temple University Hospital, Philadelphia, PA UCSD Medical Center - Hillcrest Hospital, San Diego, CA UF Health Shands Hospital, Gainesville, FL University of Colorado Hospital, Aurora, CO Wake Forest Baptist Medical Center, Winston-Salem, NC Duke University Hospital, Durham, NC Froedtert Hospital, Milwaukee, WI Maine Medical Center, Portland, ME Parkland Hospital, Dallas, TX Ronald Reagan UCLA Medical Center, Los Angeles, CA University of Utah Healthcare, Salt Lake City, UT UF Health Jacksonville, Jacksonville, FL UPMC Presbyterian Hospital, Pittsburgh, PA Status Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Released to enroll Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Ready to receive investigational product Preparing - High Priority Preparing - High Priority
22 Sites Released To Enroll Hub Site 1st Subject In Ben Taub Cedars-Sinai Emory Florida Florida HFHS Ben Taub General Hospital, Houston, TX Cedars-Sinai Medical Center, Los Angeles, CA Grady Memorial Hospital, Atlanta, GA Jackson Memorial Hospital, Miami, FL UF Health Shands Hospital, Gainesville, FL Henry Ford Hospital, Detroit, MI 26-Aug-20 11-Aug-20 OHSU OSU Regions Regions Stanford Temple Temple Texas UCLA UColorado UCSD Wake Wayne Wayne Wayne Wayne Oregon Health & Science University Hospital, Portland, OR OSU Wexner Medical Center, Columbus, OH HealthPartners Methodist Hospital, St. Louis Park, MN Regions Hospital, St Paul, MN Stanford University Medical Center, Stanford, CA Cooper University Hospital, Camden, NJ Temple University Hospital, Philadelphia, PA Memorial Hermann Texas Medical Center, Houston, TX Harbor-UCLA Medical Center, Torrance, CA University of Colorado Hospital, Aurora, CO UCSD Medical Center - Hillcrest Hospital, San Diego, CA Wake Forest Baptist Medical Center, Winston-Salem, NC Detroit Receiving Hospital, Detroit, MI Harper University Hospital, Detroit, MI Sinai-Grace Hospital, Detroit, MI Spectrum Health Hospitals Butterworth Hospital, Grand Rapids, MI 26-Aug-20 22-Aug-20 19-Aug-20 24-Aug-20
Screening Logs 14 Enrolled 86 Screen Failures 6 had Consent Obtained, but not enrolled (2 got impatient before test results came back; 3 had exclusion criteria discovered) 17 Declined Study 52 Do not meet Inclusion 13 with various (5 missing Spanish Consent form , 5 study team not available) Help! Fixed
2-3 enrollments / site / week
Site Progress 41 Sites have Advarra approval 36 Sites have completed their readiness call 29 executed contracts 2-3 enrollments / site / week 22 Released to Enroll x 50 sites = 100- 150 / week 14 sites Screening 14 Enrolled
Wish we started July 1 Wish we had 50 sites active
Things to do right now Things to do right now 1. Clinical team training Has to be done, but not hard 2. Any other people will be added to DOA? - Get their research / training certificates now 3. EPIC / CERNER / EMR builds - Pharmacy approval for placebo 4. Blood Bank programming and SOPs Talk to them now 5. Committees one more approval Use Francis Collins letter 6. Any special IRB language? - Put it in WebDCU Now. 7. Readiness call Schedule it Now
You cannot change the IRB Approved Consent Form! Your institution and local IRB can add special things in a box after the form (but this has to be approved by the central IRB). Special things go into WebDCU find out if any and put them in NOW! https://siren.network/clinical-trials/c3po/getting-started Consent Form (Updated 7-10-20) C3PO e.consent Use this training link for your practice and training needs. If you provide your email address at the end of the consent you will receive an email like the one a study participant would receive. The email to the participant reflects the email local study team members (on the e.DOA with consenting permissions) will receive when a real participant is enrolled. A site specific participant link, unique to your site and mirroring the cIRB-approved paper version of the site consent will be provided nearer to the time that your site is released to enroll. To learn more: SIREN e.consent SOP
