ÐÏà¡±á>þÿ =@þÿÿÿ:;<ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿì¥Ág ø¿JÍbjbj*§*§ ;ÜHÍibHÍibA¿ÿÿÿÿÿÿ·¢¢ÿÿÿÿ2228jäN Ì26" $%Lp%p%p%K&TŸ'¬K(XÑ}Ó}Ó}Ó}Ó}Ó}Ó}$T¶ „,÷}±£(K&K&£(£(÷}p%p%Û¨~:c-c-c-£(vp%p%Ñ}c-£(Ñ}c-c-‚un„áup%ÿÿÿÿPj’ÝYÚÿÿÿÿ)šùpF½}â~<?q¢6…³)¢6…Œáu6…ùuÄ£(£(c-£(£(£(£(£(÷}÷}U+£(£(£(£(£(£(£(ÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿÿ6…£(£(£(£(£(£(£(£(£(¢Bä: EMERGENCY USE REPORT TO RSRB Note: If this report is being completed post-treatment, according to FDA regulations it must be submitted within 5 working days of the treatment date using a Report of New Information through the HYPERLINK "https://rochesterirb.huronresearchsuite.com/IRB/sd/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5bOID%5b0A7646F3B149874E902185897C144551%5d%5d" IRB Review System. The report should be titled “Emergency Use of [INSERT NAME of DRUG/BIOLOGIC/MEDICAL DEVICE] in [INSERT DISEASE/DISORDER]”. INSTRUCTIONS: Use this form to report the emergency use of a test article (investigational drug, biologic, or device) to the RSRB according to HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_607_Emergency_Use_of_Test_Article.pdf" Policy 607 Emergency Use of Investigational Drugs, Biologics, and Medical Devices. Provide the RSRB with the following documents, including this completed report: Informed Consent (if applicable): Notification Before Treatment: Provide a copy of the consent document that will be used to obtain consent from the patient or the legally authorized representative. Notification After Treatment: Provide a copy of the signed consent document completed by the patient or the legally authorized representative. If consent was not obtained according to 21 CFR 50.23(a-c), provide documentation. For Devices Only: An independent assessment of the emergency use from an uninvolved physician, if available. Any additional relevant documents. TREATING Physician Information:Treating Physician Name:Telephone Number:Date of Report: FORMTEXT FORMTEXT FORMTEXT Department:Email Address: FORMTEXT FORMTEXT Test Article Information: FORMCHECKBOX Drug/Biologic FORMCHECKBOX DeviceName of Test Article:Sponsor/Manufacturer: FORMTEXT FORMTEXT IND Number (Drug or Biologic):IDE Number (Device): FORMTEXT FORMTEXT IND or IDE Holder: FORMTEXT patient Information:Patient Initials:Date of Treatment: FORMTEXT FORMTEXT CONTACT THE SPONSOR/MANUFACTURER/FDA:FOR DRUGS/BIOLOGICS: The sponsor/manufacturer should be contacted to determine whether the test article can be made available for use through the company’s IND. If the sponsor/manufacturer will not provide the test article under its IND, contact FDA directly to obtain authorization for the sponsor/manufacturer to ship the test article.Select one of the following: FORMCHECKBOX The sponsor/manufacturer has authorized use under an existing IND. FORMCHECKBOX The treating physician has obtained an IND for this emergency use from the FDA. FORMCHECKBOX The FDA has authorized shipment of the test article in advance of an IND submission.FOR DEVICES: FDA authorization is not required prior to shipment or use of an investigational device in an emergency situation provided the patient meets the criteria for emergency use. Whenever possible, the sponsor/manufacturer should be contacted to obtain authorization for use if the investigational device has an existing IDE. FORMCHECKBOX Authorization from the IDE sponsor has been obtained. FORMCHECKBOX There is no existing IDE for this device.EMERGENCY USE CONFIRMATION:Emergency use applies based on the qualifying criteria (all must be “YES”):YESNON/ADoes the patient have a serious or immediately life-threatening disease or condition? FORMCHECKBOX FORMCHECKBOX Is there NO standard or generally accepted therapy or alternative to treat the disease or condition? FORMCHECKBOX FORMCHECKBOX Is the probable risk from the disease or condition greater than the probable risk from use of the unapproved test article? FORMCHECKBOX FORMCHECKBOX Is there/was there insufficient time to obtain an IND/IDE or RSRB approval of a protocol at a convened board meeting? FORMCHECKBOX FORMCHECKBOX For medical devices, is there substantial reason to believe that benefit will exist from the use of the unapproved medical device? Describe below: FORMCHECKBOX FORMCHECKBOX FORMCHECKBOX Describe the conditions constituting the need for the emergency use of this test article and provide justification for its use, including any additional patient protection measures that were considered: FORMTEXT Describe the outcome of the emergency use to date, including any reportable events: [Note that any subsequent developments must be reported to the RSRB in a timely fashion using the Follow-Up Report to RSRB of Emergency Use of a Test Article.] FORMTEXT FOR DEVICES ONLY:Describe the potential benefit from the use of the test article: FORMTEXT Has the emergency use been evaluated by an uninvolved physician? FORMCHECKBOX YES FORMCHECKBOX NO If yes , attach the independent assessment as a separate document; ensure that all items under Emergency Use Confirmation above are addressed. Name of Independent Physician: FORMTEXT Date of Assessment: FORMTEXT If no , submit the written independent physician assessment once completed.CONSENT INFORMATION:Was/Will written informed consent be obtained from the patient or the legally authorized representative? FORMCHECKBOX YES FORMCHECKBOX NOIf “YES”, attach one of the following: 1) If reporting to the RSRB before treatment, a copy of the consent document. OR 2) If reporting to the RSRB after treatment, a copy of the signed consent document. If “NO”, confirm the following: FORMCHECKBOX The patient was/is confronted by a life-threatening situation necessitating the use of a test article. FORMCHECKBOX Informed consent cannot/could not be obtained from the patient because of an inability to communicate with, or obtain legally effective consent from the patient. FORMCHECKBOX Time is not/was not sufficient to obtain consent from the patient’s legally authorized representative. FORMCHECKBOX There is no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the patient’s life. 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Provide written documentation as part of this report. Name of Independent Physician: FORMTEXT Date of Assessment: FORMTEXT Signature of Independent Physician: FORMCHECKBOX Attempts have been/are being made to notify the patient and/or their legally authorized representative of the use of the test article. Comments: FORMTEXT FUTURE USE OF THE TEST ARTICLE:Do you anticipate the need for a subsequent similar emergency use of the test article? FORMCHECKBOX YES FORMCHECKBOX NO Note: FDA regulations allow for one emergency use of a test article per institution. Any subsequent use of the test article must have prior RSRB approval. If “yes”, submit a treatment use protocol for review and approval by the convened board. 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