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

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

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

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)

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

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

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.

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

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

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

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

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

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

Modifications Submitted via e-mail 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

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

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

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

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.

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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 khattak@musc.edu

Questions?