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

3. 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

4. FusionHealth Agreements
Questions regarding FusionHealth Agreements should be directed to Kayla at or Greg at

5. 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

6. NCC STUDY START UP PROCESS
Start up
1st will have information about WebDCU access and creating your DoA
2nd CIRB submission documents and consents
Creating your DoA in WebDCU™
WebDCU™ will be sending an 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)

7. 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

8. 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.

9. 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.

10. 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
• 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

11. REACH out to us we are happy to help! 