Sleep SMART Clinical Trial Agreements / Regulatory Webinar April 24, 2019

FusionHealth Agreements 43 of the 109 identified sites in the trial have a fully executed consignment agreements 66 consignment agreements still pending 54 of the 109 identified sites in the trial have a fully executed DUA 55 DUAs still pending 39 of the 109 identified sites have both agreements executed and 35 of these sites have their CTA also fully executed

FusionHealth Agreements Questions regarding FusionHealth Agreements should be directed to Kayla at kcgossel@med.umich.edu or Greg at gfletcher@fusionhealth.com

Clinical Trial Agreements (CTA) 64 of the 109 identified sites in the trial have a fully executed CTA Median turn-time to sign CTA is at 43 days currently 45 CTAs still pending 4 sites need to complete and return their 3B 3 sites need to execute a Reliance Agreement All sites should have received the following documents to help with the CTA signature process: CTA CIRB approval letters NINDS would like us to achieve the milestone of having 30 sites ready to enroll by the end of May CTA fully executed, Fusion Health Agreements fully executed, and the CIRB submission approved

NCC STUDY START UP PROCESS Start up email: 1st will have information about WebDCU access and creating your DoA 2nd email CIRB submission documents and consents Creating your DoA in WebDCU™ WebDCU™ will be sending an email with login information Add study team to your DoA and submit DoA for approval Make sure to assign all study team members roles and responsibilities. Submit the DoA for review and approval People Document space holders will populate based on study roles People Documents CV - must show current site affiliation, be signed and dated within the past 5yrs. ML - current in the state of practice COI - must have a wet ink original signature and role must match the DoA Study specific trainings (mRS, HIHSS, GCP, HSP, Protocol) are mandatory for all StrokeNet trials. Certificates of completion must be uploaded Other study specific documents, and required training(s)

REGULATORY DOCUMENTS Documents Needed for CIRB Submission Local Site Context Form- please complete and send back to the Regulatory Specialist for pre-review. Once approved please route to your local IRB representative for signature FCOI-needs wet ink signature and role must match the DoA StrokeNet CIRB Assurance Statement- needs to be signed by the site PI Partial Waiver of HIPAA authorization For Screening Performance Site Protocol Application Form Sleep SMART Main Consent v4.0- please complete and send back to the Regulatory Specialist for pre-review. PI CV

CENTRAL IRB SUBMISSION External Local IRB Process This study should not be going through a full board review at your site Your site has a Reliance Agreement (RA) in place agreeing to cede to the Central IRB as the IRB of record Local Site Context form can serve as acknowledgement NCC will be making your site central IRB submission on your behalf Site approvals are reviewed under expedited review by the cIRB Expected turnaround times for all completed and signed documents are 60 days or less Please reach out to us if you are having issues with your local requirements we we can put your IRB contact in touch with the Central IRB for guidance.

TIPS AND TRICKS ToolBox in WebDCU™ Upload your documents to WebDCU™ as soon as possible and replace rejected documents Make sure your site name is consistent across all documents No site specific edits to the consents outside of the allowable areas, no site logo’s, changes in footers etc. Always provide CIRB rationale for site specific required edits to the consents KNOW and USE your RCC Coordinator they are excellent resources Please begin collecting the required study documents, getting them signed and prepared for review.

WebDCU Document Reminders • Taking the quizzes • For ABCD2- please take sleep smart specific training, POINT training cannot be used. • Trainings and quizzes can be found on https://webdcu.musc.edu/campus/ • NIHSS- Please upload certificate of completion, not participation or credit certification. • The expiration date for the StrokeNet CIRB financial Interest Disclosure form is 2/11/2020

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