Clinical Trials Workshop Presenters: Thomas Landis, Senior Grants and Contracts Officer Erika Waday, Information and Training Specialist Jennifer Bingham, Grants and Projects Analyst II Clinical Trials Process Overview Contemplating a Clinical Trial • Confidentiality Disclosure Agreement (CDA) • Study Materials Released to PI • PI Agrees to Undertake the Clinical Trial Confidentiality Disclosure Agreement (CDA) • Purpose: To allow the sponsor to release study materials which contain confidential and proprietary information to the PI and the study team in order for them to determine whether they want and can perform the study. • Parties: Sponsor and NSHE obo UNR, with PI often signing as “Read and Acknowledged.” • Common Issues: Narrowing the definition of “confidential information,” limiting the length of the agreement, limiting the obligation of efforts to be taken to protect confidentiality. Pre-Trial Preparation • • • • • • Clinical Trial Agreement (CTA) OSP-1 Transmittal Form Negotiating the CTA and Informed Consent Form (ICF) Negotiating the Budget IRB Approval Initial Funding, Account Setup and the OSP-22 Budget Setup Form Clinical Trial Agreement (CTA) • What? It is the agreement which establishes the legal relationship between the Sponsor and the Site and sets the rules under which the study will be conducted. • Who? Parties are the sponsor and Board of Regents, NSHE, obo UNR with the PI typically signing as “Read and Acknowledged.” • Role of UNR OSP? To ensure that NSHE contractual policies and procedures are followed and to protect NSHE and the study team as much as possible. OSP-1 Transmittal Form • What? The OSP-1 Transmittal Form acts an informational cover form for all proposals forwarded to the Office of Sponsored Projects (OSP). • When? The OSP-1 should be completed and submitted when the PI has decided the accept the study. This is typically after study materials have been reviewed and the site has been approved by the Sponsor and perhaps the CTA has been sent out. • Why? Some information is needed for the proposal submission process while other information is collected for institutional reporting purposes. And, some of the information collected, such as the certifications, satisfies policies with which UNR must comply. • Requirement: The form must accompany any proposal submitted to OSP, must be completed in its entirety and must be signed by all involved project investigators, chairs/directors and deans. Instructions on completing the OSP-1 form are included in your handouts. Negotiating the CTA and ICF Role of OSP: To negotiate terms and conditions of the agreement to ensure NSHE policies and procedures are adhered to and NSHE and study team are protected. Typical Issues • Term: Sponsors want open-ended project period while UNR prefers to limit project period to < 5 years to avoid chancellor signature. • Subject Safety: Request terms in accordance with the Association for the Accreditation of Human Research Protection Programs (AAHRPP) requirements. • Subject Injury: Try to make sponsor responsible. • Confidential Information: Try to limit in similar fashion to CDA; helps preserve PI publication rights. Negotiating the CTA and ICF • Intellectual Property (IP) and Publication: As much as possible, try to protect PI’s/NSHE’s right to IP developed in course of study; remove barriers to publication. • Indemnification: Limit indemnification language to NSHE requirements. • Coordination with Study Team: Assist in communicating with and conveying to sponsor all agreement paperwork and other information in preparation of study. • Review ICF to ensure it meets AHRPP guidelines and is consistent with terms in the CTA regarding subject injury and indemnification. Role of PI and Study Coordinators: Negotiate budget, initiate request for IRB approval to generate ICF, provide input and approval as to CTA terms to OSP and coordinate with OSP in transmitting CTA “package” to sponsor. Negotiating the Budget • Site Charges vs. Per Patient Charges: Site charges are out-ofpocket expenses incurred by site such as IRB fees, dry ice and storage charges. Per patient charges are payments to be made to site for visits and procedures performed on each patient. • Budgeting Facilities and Administrative Costs (F&A): UNR is to receive 26%, representing the off-campus rate for research, on revenues from studies. Sound strategy must be used to negotiate the budget in order for F&A and site’s costs to be recovered. IRB Approval • Application for approval is initiated by PI. • Typically, an external IRB (WIRB) is used but external WIRB is not required. • IRB approval is required in order for a UNR account to be established. • End date of UNR account cannot extend beyond IRB approval end date. PI must ensure that approval is extended to extend study. Initial Funding, Account Setup and the OSP-22 Form • Initial funding: Generally, start up funding for a clinical trial is the minimum necessary to get the project off the ground. Once the OSP-1 form has been routed to OSP and any necessary IRB approvals are in place, the project spending account can be opened. • Account Setup: A project spending account will be opened for project expenditures. As revenue is received, the spending authority on the account increases. • The OSP-22 form: The OSP-22 form is used to indicate how funding will be budgeted in the account. An OSP-22 form will be needed for the amount of initial funding. Clinical Trials: Post-Award • Invoicing Sponsor • Recognize Revenue and Issuing the Notice of Award (NOA) • Controller’s Office Role • Closeout Jennifer Bingham Post-Award Analyst 775-784-4044 email@example.com Invoicing Sponsor When payment is based upon case report forms, you (the site) will bill the sponsor directly for patient visits. If payments can’t be submitted by case report, OSP will bill on your behalf. Examples of costs for which most sponsors need to be directly billed: • • • • • • • • Start-up Fees Pharmacy Start-up Fees IRB Fees Dry Ice Screen Failures Travel (Patient) Advertising Chart Review • Questionnaires • Per Subject Cost (5% withheld by Sponsor • Record Archiving Fee • Coordinator Fee • Patient Stipend or any other charges that may come up (see example Clinical Trial Patient Invoice and Other Charges Invoice) Recognizing Revenue & NOAs • Once a check has been received and posted in UNR’s accounting system, CAIS, an updated NOA will be sent to the PI and support staff to recognize revenue. At that time, the back up for the check will be sent via email to the site coordinator so they can reconcile their record. • If no back-up was provided by the sponsor, OSP will email the sponsor to request the back-up documentation. Once received, the back up will be forwarded to the site. In the event that it is unknown in what account to deposit the revenue or the check was deposited into the wrong account, OSP will not update the NOA until the sponsor provides back up documentation. Controller’s Office Role • The Controller’s Office/Cashier’s role in the clinical trial process is to identify where to credit the check, either to the invoice number or into the correct account(s). The check and any backup documentation provided by the sponsor will be forwarded to OSP. • All payments should be sent to the following Controller’s Office billing address: Board of Regents Attn: Controller’s Office/Cashier 1664 N Virginia Street Mail Stop #124 Reno, NV 89557 Closeout • Once OSP is notified by the site or receives an IRB Closure form stating the clinical trial has come to an end, closeout procedures may begin. • Upon commencement of closeout procedures, the Sponsor’s Payments made to vend report is requested. The PI on the project will be emailed the Clinical Trial Closeout Checklist and Certification form. • When all payments are received from the sponsor and the clinical trial closeout form is completed by the PI, closeout is completed on the OSP end. Any excess money will be moved to the PI’s Miscellaneous Program Development Account. Resources • OSP Website: http://www.unr.edu/sponsored-projects • Controller’s Office Website: http://www.unr.edu/campusbusiness/units-and-services/controller • Research Integrity Office (oversees the Human Research Protection Program) Website: http://www.unr.edu/researchintegrity Questions?