ASPIRE Regulatory Web DCU Clinical Trial Agreements Regulatory

ASPIRE Regulatory / Web. DCU / Clinical Trial Agreements Regulatory / c. IRB Submission – Jennifer Golan, NCC Regulatory Specialist Web. DCU Regulatory Database – Aaron Perlmutter, NDMC Site Monitoring Manager Clinical Trail Agreements – Diane Sparks & Wren Hanson, NCC Contracts

STUDY START-UP PROCESS Central IRB (CIRB) Submission • Start-up email from Regulatory Specialists contains CIRB regulatory documents needed for submission Delegation of Authority (Do. A) Log in Web. DCU™ • Web. DCU access email sent to PSC • Add site study team to Do. A and submit Do. A for approval • Make sure to assign all study team members roles and responsibilities. • People document space holders will populate based on study roles Upload Site and People Documents in Web. DCU • Site documents include: CIRB approval letters, approved consents, and translations • People documents include: CV, ML, and study specific trainings (Human Subjects Protection, GCP and Protocol) Site Readiness Call

NCC Regulatory Specialist Jennifer Golan, MS Documents Needed for CIRB Submission • Local Site Context Form- Please complete and route to your local IRB representative for signature. Regulatory Specialists are happy to pre-review prior to submission. • ASPIRE Main Consent v 2. 0 - Please review provided consent instruction document. Regulatory Specialists are happy to pre-review prior to submission. • Stroke. Net CIRB Assurance Statement- needs to be signed by the site PI • Partial Waiver of HIPAA authorization For Screening • Performance Site Application Supplement- Please review the Performance Site Protocol Application Form and indicate any site differences on this form. • PI Financial Conflict of Interest (COI) form- Only PI form (and any positive disclosures) are needed for CIRB submission. All other study team members will need to complete a COI form and forms are to remain onsite. • PI CV

NCC Regulatory Specialist Jennifer Golan, MS Local IRB Reminders • This study should not be going through a full board review at your site • Your site has a Reliance Agreement in place agreeing to cede to the Central IRB as the IRB of record • The Local Site Context form can serve as acknowledgement if your local IRB does not provide a letter or email of study deferral • Please reach out to us if you are having issues with your local requirements and we can put your IRB contact in touch with the Central IRB for guidance. Central IRB Process • Regulatory Specialists at the NCC will be making your site’s central IRB submission on your behalf • Site submissions are reviewed under expedited review by the CIRB (typically reviewed within 2 weeks)

NCC Regulatory Specialist Jennifer Golan, MS Helpful Tips ü Reference the study documents in the Web. DCU™ Tool. Box ü Upload your documents to Web. DCU™ as soon as possible and replace rejected documents ü Make sure your site name is consistent across all documents ü No site specific edits to the consents outside of the allowable areas, no site logo’s, changes in footers etc. ü Always provide CIRB rationale for site specific required edits to the consents ü Please include the study name and site name in all email subject lines ü Please do not combine multiple study documents in one email ü KNOW and USE your RCC Coordinator they are excellent resources

REACH out to us we are happy to help! Jennifer Golan Emily Stinson golanjl@ucmail. uc. edu stinsoey@ucmail. uc. edu (513) 558 -3976 (513) 558 -3979

Web. DCU Regulatory Database Aaron Perlmutter – ASPIRE Site Monitoring Manager perlmutt@musc. edu

Clinical Trial Agreements Diane Sparks, NCC Contracts - SPARKSDN@UCMAIL. UC. EDU Wren Hanson, NCC Contracts - hansonwm@ucmail. uc. edu

Clinical Trial Agreements • The Stroke. Net National Coordinating Center (NCC) at the University of Cincinnati is the fiduciary agent for all of the trials. • Clinical Trial Agreements (CTAs) are issued by the NCC to the RCC or the Satellite of the Clinical Performing Site. • There will be an email that will explain the CTA template and provide additional instructions for the return of the agreement. • The CTA should be processed as quickly as possible and returned to the NCC as turn around time is tracked as a metric.

Clinical Trial Agreements cont. • Trial Budgets are set when funding is approved by NINDS. Internal site rebudgeting is permitted. • There are no additional funds for individual site requests. • The NCC requests per patient payments for the RCC or Satellite from UC Accounts Payable based on data put into Web. DCU. • Payments are issued by Electronic Funds Transfer (EFT) due to the large number of sites that need paid and the large number of required payments. • It is the responsibility of the RCC or the Satellite to have a fiduciary service agreement in place to transfer clinical trial monies to the site performing the research.

Institution Obstacles – What are they? Contract office feels compelled to review and send revisions Non-negotiable Institutional policy – administrative budget analysis must be completed NIH budget Institutional policy – can’t release contract until IRB approval Why? #Fast Tracking the CTA Process – Let’s Brainstorm Karen Rapp & Chad Tremont – May 22, 2019

Contract Office: Wants vs. Needs What documents do they want? What is a potential compromise? Protocol Draft Protocol Budget Draft budget or total amount per pt IRB Approval CIRB approval of the Prime award Informed Consent CIRB approved Prime award Consent DRAFT Consent Conflict of Interest N/A #Fast Tracking the CTA Process – Let’s Brainstorm Karen Rapp & Chad Tremont – May 22, 2019

Examples of Contract Fast Tracking EXAMPLE SITE 1 • Administrative application completed • Do the bulk of this prior to the CTA arriving • Requires a local IRB# (not approval) • Protocol or protocol synopsis • Conflict of Interest • Confirmation from PI “accepts terms of award and project period” #Fast Tracking the CTA Process – Let’s Brainstorm Karen Rapp & Chad Tremont – May 22, 2019 EXAMPLE SITE 2 • Protocol (or draft) • Consent (or draft to review language to ensure it doesn’t conflict with bylaws of institution) • Budget (or draft)

Questions? ? Do You Know the Answers? • What is the process of obtaining review and signature on the clinical trial agreement (CTA) at your institution? • What is the turnaround time of a standard federal subaward agreement at your institution? • How does the CTA get to the Office of Research/Sponsored Programs/Grants and Contracts? • What part does the PI, Coordinator and department play in the processing of the CTA? • Who has signatory authority for the CTA at your institution? (i. e. It is not the PI. )

More Questions… • Does the legal office require all CTAs come through their office for review? • Does your institution have an electronic system that documents are uploaded into? • Does your institution require a review/approval of the “budget” prior to even reviewing the CTA? • Does your institution require approval by the Stroke. Net CIRB of your site prior to reviewing the CTA? (NIH Single IRB requirements apply to Stroke. Net trials. Stroke. Net CIRB Reliance Agreements signed prior to issuance of the CTA. )