ࡱ> @B? bjbj &}c}c(4---h,-0vxxxxxx$'!nRvv:m<8jb0,K"lHK":K":(K" : Cumulative Table of Study Serious Adverse Events (SAEs) IRB # NOTE: In the table below, indicate which events are new by highlighting in yellow. Since the table is cumulative, only new events should be highlighted each time the SAE report is submitted. Add new rows for additional events as needed. The text boxes will expand as needed. Once completed, upload the table to the Serious Adverse Event Form in the eIRB system. Follow-Up SAEs: If you are submitting a follow-up to a previously submitted SAE, insert a row into the table directly below the original SAE that is being followed-up. To insert a row, place your curser in the row of the original SAE. Then click on Table in the windows toolbar on the top of your screen. Next, select Insert from the drop-down menu, then select Rows Below. If the original SAE is numbered 1, you should number the follow-up 1.1, 1.2, 1.3, and so on. ABCDEFGHSAE #Date of SAEInitial ReportFollow-Up ReportSubject ID #Items that occurred*Key WordsRelationship 1 = Not Likely 2 = Possible 3 = Probable 4 = DefiniteIs the SAE already in the consent form (Y/N)?123 * Use these codes to complete Column E: H = Hospitalization PH = Prolonged Hospitalization PD = Resulted in permanent disability DISC = Discontinuation of drug/device for medical reasons DCA = Development of a congenital anomaly BD = Development of a birth defect CA = Cancer A = Autopsy performed LT = Life Threatening D = Death P = Pregnancy SME = Other Important/Significant Medical Event (Examples of such events include: allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, the development of drug dependency or drug abuse, etc.) INSTRUCTIONS: Please number the events in consecutive order (e.g., 1, 2, 3). The most recent events should be placed last. When adding events to the table, highlight in yellow so that the IRB reviewer will know which event(s) are new. Enter the original date of occurrence of the SAE. Check the appropriate option of submission: initial or follow-up. Follow-up would only be marked if the original SAE had been previously submitted to the IRB office for the same subject. Fill in the unique subject ID number for each subject submitted. List the code letter for the appropriate item(s). H = Hospitalization PH = Prolonged Hospitalization PD = Resulted in permanent disability DISC = Discontinuation of drug/device for medical reasons DCA = Development of a congenital anomaly BD = Development of a birth defect CA = Cancer A = Autopsy performed LT= Life Threatening D = Death P = Pregnancy SME = Other Important/Significant Medical Event Indicate Other and provide description for events that do not fall under one of the above categories. Indicate the key words of the SAE (pneumonia, renal failure, rash, etc.) There may be several key words. List all that are applicable. Choose option 1-4 to represent the relationship of causality of the SAE to the study (which may include the study drug or ancillary drugs, study procedures, the use of placebo, or randomization procedure). If sponsor reports do not use these designations of causality (for example, the reports state yes or no), then state their designation. If (3) probable or (4) definite is chosen, or the investigator believes that there is a sufficient number of similar AEs of (1) not likely or (2) possible events to cause concern, then an amendment should be submitted. The risk section of the protocol and parts of the consent form, including the discussion of risks should be modified. The IRB may query the investigator to ascertain further details of the SAEs that would determine the necessity of protocol and consent modifications. 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