1. “How to” CIRB, Regulatory, and WebDCU™ Overview July 25, 2019
ARCADIA•CSI
“How to” CIRB, Regulatory, and WebDCU™ Overview
July 25, 2019

2. Central IRB Submission Components
Susan K Roll, RN, BSN StrokeNet Central IRB Liaison

3. Prime Award Protocol Approved by Expedited Review
Minimal risk study, meets Expedited Categories 4, 6, 7a and 7b
Compensation for injury statement is not required
2018 requirements apply
Approval Documents for the Prime Award Protocol are provided to the Clinical Performance Sites
Clinical Performance Sites are approved by expedited review

4. Necessary components of the submission
Documents reviewed include:
PI CV
Delegation of Authority Report
Assurance Statement signed by Site PI
Financial Conflict of Interest Forms
StrokeNet CIRB Performance Site Application Supplement
Local Site Context Form
Partial Waiver of HIPAA Authorization for Screening Purposes
Informed Consent Template modified with site specific required language (“Track Changes” and “Clean” versions)
Site specific Stand-alone HIPAA Authorization (as necessary)
FWA
Reliance Agreement
Other Study specific forms (identified as necessary)

5. Conflict of Interest Forms
Updated and re-signed annually at the time of continuing review
Updated and re-submitted to the CIRB within 30 days of the acquisition or discovery of a new outside financial relationship
Please use Site PI Full first and last name, Full first and last name of the person signing the form, Role on the study (should match role on the DoA)
Do not use a cut and paste signature

6. StrokeNet Protocol Application Supplement
Provides information submitted with the protocol to the CIRB by the Prime Award PI
This is what the CIRB has approved will be done under this protocol at the time of initial approval
Should be used as a reference document to assist when completing the StrokeNet Performance Site Application Supplement

7. StrokeNet CIRB Performance Site Application Supplement
Additional information needed to inform the CIRB of how the local site will administer the protocol and identify any thing that may be done differently than what is outlined by the Prime Award Protocol PI
If a description is requested, please cover each point listed
Example: Compensation/Reimbursement – amount, form of payment, who will payment be provided to, when will the payment occur, what the payment is for, etc.

8. Local Site Context Form
Provides the CIRB with necessary information about your local site, local laws, institutional policies and procedures – what does your specific local site need
The contact information for the person to whom CIRB communication should be directed is to be someone at your local IRB that we can contact if we need to communicate IRB to IRB
Signature from your local IRB confirms the information provided is accurate and that they are aware of your intent to participate in this study, and lets us know if there are local ancillary reviews that need to be done before we can issue approval
The contact information for the person preparing the initial submission is requested so we can communicate directly with that person for clarification and reviewer comments
If you need additional space for answers you can always submit a WORD document with more details

9. Revisions and ARCADIA-CSI specifics
SITE NAME AND ALL LOCATIONS WHERE STUDY ACITITIVES WILL TAKE PLACE OR WHERE PARTICIPANTS WILL BE SEEN
Additional guidance regarding the purpose of the form for the local IRB/Human Research Protection Program or equivalent Office
This study is not enrolling non-English speaking populations
answer no to question 1.a.
for question 1.b. select Other and enter “N/A per protocol” in the text box

10. Partial HIPAA Authorization Waiver for Screening Purposes
The purpose of the this waiver is to be able screen for possible participants and to determine eligibility for the study without obtaining HIPAA Authorization from the possible participants
The answers to the questions on the form should be directed at screening the medical record for possible eligibility
Separate questions for information about those who agree to participate and those who do not agree to participate

11. Informed Consent Template
Include a “track changes” version of all the changes you are making in the editable sections of the template (please follow the instructions provided)
After making those edits, accept all changes to make the “clean” version
The name of the site must be consistent throughout the document
Avoid abbreviations (if used, explain the first time used)
Use complete formal first and last names of the site PI
Site logos are not accepted
Do not bold or italicize fonts
If you are adding local required language, make a comment to tell us it is “required language” as a courtesy

12. Site-Specific Stand-Alone HIPAA Authorization
Only if not able to embed in the ICD as required by site
StrokeNet entities need to be inserted in the Site-Specific Stand-Alone HIPAA Authorization – if not able to insert, ask for alternative template language to list them in the ICD

13. Reliance Agreement and FWA
Supportive documents that must be in place prior to CIRB review
Many RAs have been in place since StrokeNet began in 2014

14. Modifications
Submitted via to the NCC Project Manager in a “timely” fashion, to allow for processing before the change takes place whenever possible
Examples of modifications are:
Changes to the DoA
Changes to the site phone number
Changes to the number to be enrolled at your site

15. NCC STUDY START UP PROCESS
Start up
Start up with the CIRB regulatory packet was distributed to all the selected sites on Tuesday July 23.
StrokeNet cover letter
You will be receiving an from WebDCU™ with log in instructions
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 (HSP, GCP and Protocol) are mandatory for all StrokeNet trials Certificates of completion must be uploaded

16. NCC Regulatory Specialist Emily Stinson, MS and Jennifer Golan, MS
Documents Needed for CIRB Submission
Local Site Context Form- please complete and send back to the Regulatory Specialist for pre-review. Please note that ARCADIA CSI will not be enrolling non English speaking subjects. 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
Protocol Application Supplement
Performance Site Application Supplement- Please review the instructions at the top of this form
ARCADIA CSI Consent v1.0- please complete and send back to the Regulatory Specialist for pre-review. Please note that the compensation for injury element is not required for ARCADIA CSI

17. NCC Regulatory Specialist Emily Stinson, MS and Jennifer Golan, MS
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 Central IRB
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 can put your IRB contact in touch with the Central IRB for guidance

18. NCC Regulatory Specialist Emily Stinson, MS and Jennifer Golan, MS
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 as they are excellent resources
Please begin collecting the required study documents, getting them signed and prepared for review.

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

20. ARCADIA-CSI in WebDCUTM
ARCADIA-CSI will be a new, separate database in WebDCU™, so we will have a new button for this study.
This means we will have a separate DOA, regulatory database, separate CRF binders, etc.
Randomized ARCADIA subjects that are taking study drug will be eligible for ARCADIA-CSI enrollment.
Subjects will need to be enrolled in the ARCADIA database first
Subjects enrolled in both studies will have the same Subject ID
The Subject Enrollment form for ARCADIA-CSI will have a drop down box from which sites will select the correct subject ID that matches the ARCADIA subject ID
Main WebDCUTM contact: Faria Khattak

21. Questions?