Get With The Guidelines® -Stroke Hospital Participation ...



Get With The Guidelines? -Stroke Hospital Participation Agreement forMild and Rapidly Improving Stroke Symptoms (“MaRISS”) Research StudyMaRISS Study ID No._________________This Hospital Participation Agreement (“Agreement”) is made and entered into as of , 2017 (“Effective Date”) through September 30, 2019 (“End Date”) by and between the American Heart Association, Inc. (“AHA”), a New York not-for-profit corporation with offices at 7272 Greenville Avenue, Dallas, Texas 75231 and (enter hospital name here) (“Participating Site”), a (enter hospital corporate entity type here) located at (enter hospital address here).WHEREAS, AHA is a non-profit health organization with volunteers throughout the United States who are dedicated to the goal of building healthier lives free from cardiovascular disease and stroke, through research, advocacy and the development of programs that improve patient access to high-quality health care;WHEREAS, the AHA is collaborating with the University of Miami (“UM”) to conduct the Mild and Rapidly Improving Stroke Symptoms Research Study (“Study”) and is recruiting hospitals currently enrolled in the Get With the Guidelines? Stroke (“GWTG-S”) program to participate in the Study;WHEREAS, the GWTG-S program includes the national data registry (“GWTG-S Registry”) managed by Outcome Sciences, Inc., a Quintiles company (“Quintiles”), AHA’s data warehouse and technology vendor;WHEREAS, Participating Site has entered into an agreement with Quintiles pursuant to which Participating Site has enrolled in GWTG-S and utilizes the Patient Management Tool (“PMT”) to submit certain patient data into the GWTG-S Registry;WHEREAS, the AHA has authorized Quintiles to provide Participating Site with access to the PMT for purposes of submitting certain Study data;WHEREAS, Participating Site desires to participate in the Study;NOW THEREFORE, in consideration of the mutual promises set forth herein, it is agreed by and between AHA and Participating Site that:The AHA and Participating Site enter into this Agreement for purposes of Participating Site’s participation in the Study and agree to the terms and conditions contained hereunder. Participation in the Study. By executing this Agreement, Participating Site agrees to participate in Study, which allows Participating Site to submit certain patient data into the GWTG-S Registry’s Study-specific data fields for purposes of Study pliance. The AHA and Participating Site agree to comply with the Health Insurance Portability and Accountability Act of 1996, as amended, (“HIPAA”) and regulations promulgated thereunder, the Privacy Rule and Security Rule as provided in 45 C.F.R. Parts 160 and 164, including revisions and regulations promulgated under the HITECH Act; and all applicable federal and state laws and regulations relating to the conduct of the Study, including those related to the conduct of clinical research, data privacy, safety reporting, financial disclosure, conflict of interest, and patient safety.Term and Termination. This Agreement will become effective on the Effective Date and will continue until the End Date. AHA may terminate this Agreement immediately upon written notice to Participating Site if AHA or UM cancels the Study. Either party may terminate this Agreement without cause upon thirty (30) calendar days written notice to the other party. Either party may terminate this Agreement for material breach upon thirty (30) calendar days written notice to the other party.Study Objectives. The overall objective of the Study is to clarify the long-term outcomes of Study patients (“Subjects”) with mild or rapidly improving stroke symptoms and to examine the association with tPA treatment. The Study will follow the Study Protocol, attached hereto as Exhibit E. The Study Protocol may be modified from time to time but will remain substantially similar to Exhibit E. The AHA will notify Participating Site of any modifications to the Study Protocol.Participating Site Responsibilities.Institutional Review Board (IRB) Approval. Participating Site shall obtain the necessary approvals from the applicable IRB(s) before starting the Study, and will provide AHA with copies of such approvals within five (5) business days of receiving confirmation of IRB approval. If Participating Site is without an internal IRB, Participating Site will submit a request to Chesapeake or other AHA approved IRB for study protocol and informed consent review and approval. Participating Site will submit annual continuing reports to the IRB as required by the IRB and a final report once all activities are complete, in addition to complying with any other conditions required by the rmed Consent. Participating Site shall obtain an informed consent form (“ICF”) from each Subject prior to the Subject’s participation in the Study. Participating Site will ensure that the ICF was approved by the AHA and IRB before use, and will maintain ICF records as needed for Study related auditing. Participating Site agrees that it will not perform any study-specific procedure or assessment prior to obtaining a completed ICF from Subject.Subject Data Recruitment. Within the first year of its staff completing the Training Module, Participating Site shall be responsible for recruiting a minimum of six (6) patients, and shall continue to actively recruit patients throughout the term of this Agreement. Participating Site acknowledges and agrees that AHA shall not remit reimbursement of the Start-up costs and Training Module fees (as outlined in Exhibit A) until Participating Site successfully enrolls its first patient in the Study. Subject Data Collection. Participating Site shall ensure that all Subject data collection meets applicable patient privacy and security standards and the data provided for the Study is accurate and complete. Participating Site will attend Web-based Study training sessions provided and scheduled by AHA, which will include Study Protocol specifics (assessment scales, data collection, data transmission) and clinical research forms.Status Reports. Participating Site will provide to the AHA regular updates and project status reports on the day-to-day progress of Participating Site’s participation, including Subject enrollment for the Study, once patient recruitment is launched and according to a schedule mutually agreed to by the parties, but in any case no less frequently than monthly. These progress reports will include, but are not limited to, the following information:Status of compliance, including IRB approval documentation;Evidence of staff and clinician training for all Participating Site’s Study administrators, including Collaborative Institutional Training Initiative (“CITI”) human subjects training, or the equivalent, and completion of the AHA training module on Study protocol;Number of Subjects enrolled in the study;Confirmation of ICF received from all enrolled Subjects;Study-specific clinical assessment data (AHA to define), to be collected via the PMT;Threats to Study validity or challenges the Participating Site may face with adhering to Study design;Any breaches in confidentiality or deviations from Study design on the part of Participating Site; andAll Serious Adverse Events that occurred during the reporting period.Participating Site will identify an individual project administrator or Study administrator who will oversee the Participating Site’s participation in the Study and will be the primary contact with the AHA.Participating Site will make its project administrator or Study administrator and Study-related staff, as needed, available to AHA personnel responsible for on-site monitoring of the Study, and will cooperate with all such monitoring, training and reporting to AHA. Participating Site will provide necessary space for AHA on-site monitoring staff to perform their monitoring and review functions. During on-site monitoring visits from AHA, Participating Site will allow AHA MaRISS staff access to the Study documents, including informed consent forms and source documents, pertinent hospital or medical records and patient charts. AHA MaRISS staff will not be allowed unsupervised access to electronic health records or other non-research records that contain protected health information.Reporting Serious Adverse Events. In the event Participating Site becomes aware of a Serious Adverse Event (SAE) that is related to or associated with the use of tPA, Participating Site must report to UM as set out in Exhibit C Reporting Adverse Events and submit the SAE form attached hereto as Exhibit D.AHA Responsibilities.AHA will provide the following Study information to Participating Site:Access to the GWTG-S PMT through Quintiles;GWTG-S PMT coding instructions;Supplemental Special Initiative (Study) research tab within the PMT Supplemental Study data elements;Study Training Module and Subsequent Certification Documentation:AHA will provide scheduled and ad hoc training regarding GWTG-S PMT, GWTG-S coding instructions, supplemental special initiatives (Study) research tab, supplemental coding instructions, and supplemental study data elements.Contact information for AHA staff responsible for MaRISS.b. AHA will be responsible for the direct monitoring of the Participating Site through periodic scheduled site visits. All site visits shall be at mutually agreed upon times, except in circumstances where AHA reasonably believes that Participating Site is in material breach of the terms of this Agreement. Such site visits will include review of participant recruitment, flow of data, quality controls related to the data, including logging and maintaining required documents, Adverse Event reporting and Participating Site’s adherence to protocols.c. Following on-site monitoring visits by AHA, AHA will provide Participating Site with a site monitoring report regarding any problems or issues that may have been noted during the visit. A follow-up timeline will be provided to ensure that any noted issues are resolved and corrections are implemented when pensation. AHA will reimburse Participating Site for satisfactory completion of all Study-related obligations hereunder, including Subject enrollment and data collection, as set out in Exhibit A. No costs or expenses related to any medical treatment of Subjects will be paid. Participating Site will not pay another physician or facility to refer Subjects to the Study. Participating Site will comply with all applicable disclosure obligations relating to compensation as may be required by any IRB medical committee or other medical or scientific organization affiliated with Participating Site. AHA will reimburse the Participating Site an amount not to exceed $25,000.Anti-Corruption/Anti-Fraud. Participating Site agrees that the compensation provided constitutes the fair market value for the services rendered in light of the duties required to be performed hereunder; and will not affect Participating Site’s judgment with respect to the advice and care of each Subject.Debarment. Participating Site represents that neither it nor its staff and personnel involved in the Study have ever been debarred, disqualified or suspended by the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) or other regulatory body, nor have debarment, disqualification or suspension proceedings been commenced. During the term of this Agreement, Participating Site will not employ or otherwise engage any individual to perform Study services who has been debarred, disqualified or suspended as described in this paragraph. Participating Site represents that it is in good standing under all applicable licensing bodies. In the event Participating Site receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification as noted above, Participating Site shall immediately notify AHA in writing, and AHA shall have the right, but not the obligation, to terminate this Agreement, effective, at AHA’s option, immediately or at a specified future date.Inspections/Audits of Participating Site. AHA and its agents or affiliates may visit Participating Site during normal business hours to monitor the Study and compliance with this Agreement. Participating Site will be notified prior to any such visit and will provide assistance and cooperation. The auditor will maintain the confidentiality of all records viewed. Participating Site also will cooperate with all regulatory audits or inspections and will notify AHA promptly after receiving any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study.Representations and Warranties of Participating Site. Participating Site represents and warrants that:Participating Site is duly organized, validly existing and in good standing under the laws of its state where it is licensed with full organizational power adequate for executing, delivering, and performing its obligations under this Agreement;Participating Site will comply with all applicable federal and state laws and regulations related to Participating Site’s participation in the Study; andAt all times during its participation in the Study, Participating Site will maintain commercially reasonable types and levels of insurance coverage, including but not limited to professional liability coverage, and provide evidence of such coverage to AHA upon request.Representations and Warranties of AHA. AHA represents and warrants that:AHA is a not-for-profit corporation duly organized, validly existing, and in good standing under the laws of the State of New York with full corporate power adequate for executing, delivering, and performing its obligations under this Agreement;AHA will comply with all applicable federal and state laws and regulations related to Study; andAHA will maintain commercially reasonable types and levels of insurance coverage.Indemnity. Each party (the “Indemnifying Party”) agrees to indemnify and hold harmless the other party, its affiliates, contractors and licensors, their officers, directors, employees and agents from and against any liability and costs incurred in connection with any claim arising out of any breach by the Indemnifying Party of it representations, warranties and agreements contained in this Agreement.Intellectual Property.Pre-existing Intellectual Property. Ownership of trademarks, service-marks, inventions, discoveries, works of authorship and other developments existing as of the Effective Date hereof, (collectively, Pre-existing Intellectual Property), is not affected by this Agreement, and neither AHA or Participating Site shall have any claims to or rights in any Pre-existing Intellectual Property of the other except as may be otherwise expressly provided in any other written agreement between them. For clarity, any and all existing data residing in or obtained from the AHA’s GWTG-Stroke registry database maintained by AHA, or its vendor, will be the sole and exclusive property of AHA or its licensors. Participating Site shall have no rights to use or display in any manner the service marks owned by the AHA without the express written permission of the AHA.Study Results. Any and all Study results and/or data analysis created by UM and directly relating to the Study (“Study Data Analysis”) shall be the sole and exclusive property of UM or AHA as its licensee. No rights whatsoever in the Study Data Analysis are granted hereunder to Participating Site.MaRISS Publication Policy. The MaRISS limited dataset originates in the GWTG-Stroke registry and will be analyzed by UM. UM has first right to publish and present the data and Study Data Analysis at scientific meetings. If UM does not publish within 18 months of completion of the Study, the AHA has the right to publish the Study Data Analysis. All proposed publications and presentations need to be approved by the MaRISS Steering Committee. All publications are also subject to the written agreements between UM and the AHA, and UM and Genentech, and will comply with the AHA’s Get With The Guidelines Publication Policy. Sub-analyses not specified by the Study Protocol can be considered for review. A Participating Site may submit proposals to the MaRISS Steering Committee, which will evaluate the proposal for scientific merit and integrity, and potential conflict with other proposals or with the main Study objectives. These sub-analyses may be published after the main conclusions of the MaRISS Study have been published. The MaRISS Steering Committee makes the final determination on approval of these analyses.Data Ownership. Participating Site authorizes AHA and Quintiles to include its Participating Site Data in AHA’s GWTG-S Registry.Subject Data. All information relating to Subjects and all Participating Site data shall be the exclusive property of Participating Site, subject to the rights, if any, of Subjects in individually identified or identifiable information, and subject to the rights granted to AHA in this Agreement. To the extent permitted by law, all data that are: (1) generated by Participating Site in the processing or reporting of Subject encounters, and (2) contained in files of Participating Site, shall be owned by Participating Site.Data Made Available to AHA. Participating Site authorizes AHA to receive and Quintiles to disclose to AHA, at AHA’s request, Participating Site’s Limited Data Set for the Study, to the extent permitted by the Privacy Rule and the Security Rule and applicable state law and related agreements. In addition, Participating Site authorizes Quintiles to disclose to UM Participating Site’s Subject Data entered into the PMT, for purposes of the Study. AHA also shall be allowed to access, use and disclose related protected health information of Study Subjects as necessary to carry out its duties under this Agreement.Confidentiality. For the purposes of this Agreement, “Confidential Information” is defined as any information including, but not limited to, software, materials, data or business, financial, operational, customer, vendor and other information disclosed by one Party (“Disclosing Party”) to another Party (“Receiving Party”), which is not generally known by or disclosed to the public or known to the Receiving Party except by reason of the negotiation or performance of this Agreement. Confidential Information shall include the Study Protocol defined as the detailed document marked “Confidential” that describes the objectives, design, methodology, procedures, statistical considerations, approaches and plan for the Study whether disclosed to Participating Site during the effective period of this Agreement or discovered by Participating Site as a result of the performance of the Study. All materials, data and reports relating to the Study, as well as intellectual property of AHA, are Confidential Information and the property of AHA or its licensors. All medical records and other source documents maintained by Participating Site shall remain the property of Participating Site. Participating Site will keep the Confidential Information confidential and disclose it only to its employees involved in conducting the Study on a need-to-know basis. These confidentiality obligations will continue until five (5) years after completion of the Study, but will not apply to information to the extent that it: (i) is or becomes publicly available through no fault of Participating Site; (ii) is disclosed to Participating Site by a third party not subject to any obligation of confidentiality; (iii) must be disclosed to IRBs; (iv) is permitted to be disclosed under an ICF; or (v) is required to be disclosed by applicable law, including to report public health/safety information. Participating Site will notify AHA immediately in the event of a disclosure of Confidential Information not permitted by this section.Limitation of Liability; Remedies.Participating Site agrees that the use of Study Protocol, PMT or GWTG-S for any purpose related to patient care cannot be controlled by the AHA and must not be substituted for the professional skill and judgment of a licensed healthcare provider. Participating Site acknowledges that AHA is in no way responsible for any pharmacological, medical, legal or similar information contained in, entered into, or used in connection with Study;Study materials are provided on an “AS IS, AS AVAILABLE” BASIS AND THE AHA DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.Participating Site acknowledges and agrees that the AHA is not responsible for any errors in or omissions from the Study, including, without limitation, any interpretations therefrom, and participation is entirely at Participating Site’s sole risk; and, further, that Participating Site assumes any and all claims, damages, liabilities, suits, and expenses arising out of or in connection therewith;Except for the indemnity provided in section 13 above, the entire liability of the AHA, and Participating Site’s exclusive remedy for damages from any cause related to or arising out of this Agreement, regardless of the form of action, whether in contract or in tort, will not exceed the amount paid by AHA during the previous twelve month period to Participating Site. IN NO EVENT SHALL THE AHA BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO, LOSS OF USE, REVENUES, PROFITS OR SAVINGS, EVEN IF THE AHA KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES, OR CLAIMS, DEMANDS OR ACTIONS AGAINST PARTICIPANT BY ANY PERSON; andThe remedies set forth throughout this Agreement constitute the Participating Site’s sole and exclusive remedies and the AHA’s entire liability in the event of a breach or any other cause of action arising out of, or in connection with, this Agreement.Independent Contractors. Participating Site is an independent contractor and will not be considered the partner, agent, employee or representative of AHA or UM, and neither AHA nor UM will be responsible for any employment-related taxes, benefits or insurance related to Participating Site’s participation in the Study. Participating Site will not have authority to make agreements with third parties that purport to bind AHA or UM.Miscellaneous. This Agreement constitutes the complete agreement between the parties and replaces all other written and oral agreements relating to the Study. No amendments or modifications to this Agreement will be valid unless agreed to in writing by all parties. Failure to enforce any term of this Agreement will not constitute a waiver of such term. If any part of this Agreement is found to be unenforceable, it will be reformed to the extent possible, and the rest of this Agreement will remain in effect. This Agreement will be interpreted under the laws of the State of Texas. This Agreement will be binding upon the parties and their successors and assigns. Participating Site will not assign or transfer any rights or obligations under this Agreement without the written consent of AHA. Sections 5 through 7, and 10 shall survive expiration or termination of this Agreement.IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized representatives as of the Effective Date.American Heart Association, Inc.Participating SiteBy: ________________________________By: ________________________________Print Name: Yosef Khan, MD, MPH, PhDPrint Name: enter name hereTitle: Dir, Healthcare Quality Research Title: enter title hereand BioinformaticsDate: ______________________________Date: ______________________________EXHIBIT ACompensation ScheduleAHA shall compensate the Participating Site an amount not to exceed $25,000 for its participation in the Study as follows:Funds to cover Start-up costs incurred by Participating Site ($500 for Year 1 only).Reimbursement for documented costs incurred for IRB submission (maximum $2,500 for Year 1 and maximum $1,250 for Year 2).Completion of Training Module ($500 one-time fee paid to Participating Site upon completion of Training Module by all MaRISS staff). Eligible MD and RN trainees will receive one (1) hour of Continuing Medical Education (“CME”) credit. Subject enrollment $400 per Subject, and an additional 22.7% Facilities and Administrative costs (formerly indirect costs), and detailed as follows:$270 per Subject for completing Study assessments up to day 3 (obtaining informed consent, patient enrollment, collecting information of already performed standard of care assessments, performing MaRISS NIHSS, TOAST, and completing MaRISS forms;$30 per Subject for a 10 minute phone call to perform modified Rankin Scale at 30 days;$100 per Subject for the 30 minute phone call at 90 days; and$90.80 per Subject for Facilities and Administrative costs (formerly indirect costs).$50.00 per Subject who completes the Patient Reported Outcome Tool questionnaire online, which is contained in the Study Protocol. This payment shall only be available until completion of 100 cumulatively accrued questionnaires submitted by Subjects from across all MaRISS Participating Sites. International Stroke Conference (ISC) attendance $500 per year for ISC registration for 2 years, which includes:This covers one attendee per Participating Site; andParticipating Site to invoice AHA after attendee returns from ISC.In order to qualify for ISC reimbursement in the current year, Participating Sites that have been actively recruiting for the 6 months immediately preceding the ISC event must have enrolled at least 3 patients into the Study.As provided for in Section 5(c), Participating Site understands that it is responsible for recruiting a minimum of six (6) patients within the first year of completing the Training Module. Upon successful enrollment of its first patient, AHA will reimburse Participating Site Start-up costs and Training Module fees.Participating Site to invoice AHA using the Invoice Template included herein as Exhibit B.Participating Site to submit invoices to:Yosef Khan, MD, MPH, PhDDir, Healthcare Quality Research & BioinformaticsAmerican Heart Association/American Stroke Association7272 Greenville AvenueDallas, Texas 75231Email: mariss@EXHIBIT BParticipating Site InvoicePARTICIPATING SITE: ______________________________INVOICE NUMBER: __________________________INVOICE DATE: _____________________________Within 90 days of completion of each item listed below, please submit an invoice to AHA.ItemQuantityUnit CostUnit RatePreviously InvoicedAmount Due this InvoiceStart-up Costs$500Lump SumIRB submission – Year 1$2,500EachIRB submission – Year 2$1,250EachCompletion of Training Module $500Lump SumSubject Enrollment$400Each22.7% of $400 Facilities and Administrative costs (per patient)$90.80Each PatientSubject questionnaire completion in Patient Reported Outcomes Tool $50Each Patient ISC Attendance – Year 1$500EachISC Attendance – Year 2$500EachTotalTotal Amount Previously InvoicedTotal Amount Due this InvoiceEXHIBIT C Reporting Adverse EventsIn the event Participating Site becomes aware of a Serious Adverse Event (“SAE”) that is related to or associated with the use of tPA, Participating Site must report to the UM within one (1) business day of becoming aware of the SAE.Adverse Event (“AE”). Any untoward medical occurrence in a Subject who is administered tPA, and which does not necessarily have a causal relationship with any treatment provided to Subject during the term of the Study, however insignificant it may appear to be. This also includes an SAE with an associated product quality or technical complaint regarding tPA.Serious Adverse Event (“SAE”). An AE should be classified as an SAE if the following criteria are met:It results in death (i.e., the AE actually causes or leads to death);It is life threatening (i.e., the AE, in the view of the Participating Site, places the Subject at immediate risk of death. It does not include an AE that, had it occurred in a more severe form, might have caused death);It requires or prolongs inpatient hospitalization of Subject;It results in persistent or significant disability/incapacity (i.e., the AE results in substantial disruption of the Subject’s ability to conduct normal life functions);It results in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to tPA; orIt is considered a significant medical event by the Participating Site based on medical judgment (e.g., may jeopardize the Subject or may require medical/surgical intervention to prevent one of the outcomes listed above).Assessment of Adverse Events. All SAEs whether volunteered by the Subject, discovered by Study personnel during questioning, or detected through physical examination, laboratory test, or other means will be reported appropriately. Each reported SAE will be described by its duration (i.e., start and end dates), regulatory seriousness criteria if applicable, suspected relationship to the rtPA (see following guidance), and actions taken.Reporting Form. Participating Site shall submit a separate Serious Adverse Event Reporting Form (“SAE Form”) for each Event within one (1) business day following the SAE. An SAE Form is provided as Exhibit D; andCompleted SAE Forms shall be sent via email and fax to:Iszet Campo Bustillo, MPHUniversity of Miami, Neurology Department 1120 NW 14th Street, Suite 1364Miami, Florida 33136Email: icampo@med.miami.edu Fax: (305) 243-7081 ................
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