PI and Coordinator Webinar August 21, 2019

Overview Site Status and Enrollment Unanticipated Event Reporting-Sue Roll

Site Readiness FusionHealth Consignments Agreements:77 FusionHealth Data Use Agreements: 83 Clinical Trial Agreements: 102 CIRB approved sites: 72 Sites with all contracts executed and CIRB approval: 57

Enrollments Sites open to enrollment: 31 Subjects enrolled: 93 Subjects randomized: 31 August randomizations: Brooks Rehabilitation Hospital, Jacksonville FL- Taisiya Matev, Raine Osbourne PhD, & Parag Shah MD University of Alabama, Birmingham AL- Tammy Davis and Soo Young Kwon MD St. Joseph’s Hospital and Medical Center, Phoenix AZ- Kelly Sims and Supreet Kaur MD Saint Luke’s, Kansas City MO- Debbie Summers, Christine Kennish, & Suzanne Crandall MD Cedars Sinai, Los Angeles CA- Vicki Manoukian and Oana Dumitrascu MD Palmetto Health Richland, Columbia SC- Phil Fleming and Souvik Sen MD Hospital at the University of Pennsylvania, Philadelphia PA- Nichole Gallatti and Steven Messe MD Yale New Haven Hospital, New Haven CT- Radu Radulescu and Klar Yaggi MD In order to schedule your site readiness call, the following need to be completed: Both FusionHealth Consignment and DUA executed CTA executed CIRB Approval All required training completed and uploaded in WebDCU- Trainings can be found here https://webdcu.musc.edu/campus/ KOEO access confirmed and equipment received by site Recommended dummy Nox T3 test completed

Reporting Unanticipated Events to the CIRB and in WebDCU™ Susan K. Roll, RN, BSN, Central IRB Liaison National Central Institutional Review Board

Location in WebDCU™

Unanticipated Event Report Form

(brief but individualized) Example: Hospitalization for pneumonia Select site from drop down Title of event (brief but individualized) Example: Hospitalization for pneumonia Enter subject ID (if applicable, otherwise leave blank)

Was the event unexpected? Is the event related or possibly related to the research? Does this event suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized?

Assure that your descriptions do not include PHI other than the dates indicated (and time if necessary), also avoid naming people and placing blame Describe the event with details (date of occurrence and site awareness, sequence of events, actions taken or treatments given, resolution, if participant remains in the study, and if applicable has the sponsor been notified. 8000 Briefly describe any corrective actions or plan to prevent this type of event from happening again. If this is not a preventable event then indicate this is not preventable

Types are either one of the first 12 OR 13 Events or information fits into one of these 12 types of events Keep in mind the choice “Other unanticipated problem comparable to the events listed above” OR The event or information does not fit the list above

Currently all sites are StrokeNet sites – answer Internal event

PI Assessment of risks/benefits and need for change Does the PI feel the event is related to the conduct of the research at the local site? Does the PI feel there is a meaningful change to the risks/benefits for the participants at the local site? If no is selected for question 14, explain why there is no change to the risks/benefits at the local site.

Only if question 12 is answered: External Site The answer options will be yes/no radio buttons

Only if the answer to question 13 is yes and questions 14 & 16 are no. If PI feels the event is related to the conduct at the local site but there is no meaningful change to the risks/benefits at the local site and it is an external event

Once you select Save Record, the screen will change and you will receive guidance on prompt reporting vs reporting at the time of continuing review. Prompt reporting = within 10 days of site knowledge

The following question on the Adverse Event Form relates to this form The following question on the Adverse Event Form relates to this form. There may be cases in which you may need to fill out the Unanticipated Event From first for guidance on the answer to this question.

Please do not edit or update the form once it has been reported to the CIRB