Emergency Use Report (Subsequent to use) doc 8 08_ACR

University of Miami Human Subject Research Office POST - EMERGENCY USE REPORT Notification of Use of Drug, Biologic or Device (Subsequent to Administration of the Test Article) [21 CFR 56.102(d)] This report must be submitted to the Human Subject Research Office within business days after the use of the test article If you have any questions on how or when to use this form contact us at the IRB Office 305243-3195 Definitions Emergency Use: Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)] Test Article: A test article includes any drug, biological product, or medical device for human use [21 CFR 56.102(l)] Life-threatening: For an emergency use of a test article, FDA regulations define a “life threatening” situation to include the scope of both life-threatening and severely debilitating, as defined below Life-threatening means diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival The criteria for life-threatening not require the condition to be immediately life-threatening or to immediately result in death Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible Severely debilitating means diseases or conditions that cause major irreversible morbidity Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke Administrative Information eProst # Department Date of Report Date of Use             Role* Name of Physician Reporting the Use Contact Person             Name Phone Fax                                     Investigational Article Information I am informing the IRB of the       use of List your drug or device and IND/IDE/HUD# FDA status       Name of Investigational Drug or Biologic: IND #: Name of Investigational Device: IDE #: Restrictions Post-Emergency Use Report Version 8/08 IND/IDE sponsor’s name             University of Miami Has there been a previous Emergency Use of this test article at this site? (Please note: FDA regulations will only permit one emergency use of a test article at an institution.) Patient is Does the patient belong to any of the vulnerable population groups? Yes STOP Use of this article again will require submission of a new study for full board review Contact the Human Subject Research Office at (305) 243-3195 to discuss how to most expeditiously get this study reviewed No Explain how you have verified this information:       Under the age of 18 18 or older Yes No Pregnant women, fetuses, or neonates of uncertain viability or nonviable (45 CFR Part 46, Subpart B)       Emergency Use Exemption from Prior Board Review The medical indication is Emergency use situation: All four of the following conditions must apply for exemption from prior board review: Agent(s) Dose Duration Off Label Use Frequency Location of treatment (hospital & service) Explain condition requiring use       YES A life-threatening or severely debilitating situation exists necessitating the use of the investigational drug, biologic or device; AND YES No standard acceptable treatment is available; AND YES There is not sufficient time to obtain IRB/FDA approval                   YES       No                   Prior course of treatment (include medication)       Current Patient Status/Result of Use       Description of Life Threatening Condition: a Diagnosis:       b Why was the condition considered life-threatening?       c Please justify your opinion that there is no alternative method of approved or generally recognized therapy available that provides an equal or greater likelihood of saving the subject's life       d What made the physician(s) conclude that there was no standard acceptable treatment available, so that an investigational treatment has to be offered?       Post-Emergency Use Report Version 8/08 University of Miami If the test article is a drug, what is the drug trial phase status, as assigned by the FDA? Phase I Phase II Phase III Phase IV Treatment If the test article is a device, what is the device status, as assigned by the FDA? This device is: Significant Risk Non-Significant Risk This device is: Investigational Marketed What was the source (supplier or manufacturer) of the test article?       How did the physicians gain possession of the test article?       Will the patient or his/her health care provider be required to pay for any related procedures or products? No Yes, please explain:       Who is responsible for costs incurred due to adverse events?       Identify the risks (current and potential):       NA a) Describe the expected frequency, degree of severity, and potential reversibility       NA b) Describe possible late effects:       NA c) Risks from article:       NA e) How will the patient be assessed for the occurrence of adverse events described above?       NA f) Describe your monitoring plan:       Informed Consent/Emergency Waiver What type of informed consent process was implemented prior to administration or application of the test article to the patient?       Informed consent obtained from the Subject or the subject legally authorized representative: Yes; attach a copy of the consent form and skip section below No; provide justification below and complete section If informed consent was not obtained before use please provide justification a Subject had a life-threatening condition necessitating use of test article Explain:       b Consent could not be obtained because of inability to communicate with, or obtain legally effective consent From the subject Explain:       c Time was insufficient to obtain consent from the subject’s legal representative Explain:       d No alternate method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subjects life Explain:       Post-Emergency Use Report Version 8/08 University of Miami If the mental acuity of the patient was in doubt, the person who gave the informed consent was: Legally Appointed Guardian Patient advocate named in a Durable Power of Attorney for Health Care Next-of-Kin: Spouse Adult Child Parent Adult brother or sister If the patient was age