ࡱ> NPM bjbj 4B..qqqqq<\ceeeeee$ ~#qqq222qqc2c22:,_ p( O0 RX$6~X$_X$q_2~X$. 7: To Be Used ONLY to Report Adverse Events Please fill in name of reporting individual, your contact information and your role if any in this research. Anyone may report adverse events. Name:IRB Number:Address:Role in Project:Phone:Project Investigators:Email:`Title of Project:Report of Adverse events or Unanticipated Problems With Risk or Potential for Risk to Participants or Others Adverse Events should be reported within 10 days or on notification. All deaths or life threatening events MUST be reported in 2 days of occurrence. Safety measures should be taken at once and continued during IRB notification. Adverse Event is an undesirable and unintended, although not necessarily unexpected result of therapy or intervention. (45CRF 46.103(b)(4), 21CRF 56.108(a), 21CRF 312.30(b)(ii), 21CRF312.66) e.g. intestinal bleeding with aspirin therapy, headache after spinal tap. (IRB Guidebook) Serious Adverse Event - any event that may result in the following: a death, a life threatening experience, a prolonged or required hospitalization, persistent or serious disability, congenital anomaly or birth defect, any event requiring intervention to prevent one of the outcomes previously mentioned. (21 CFR 312.32 a) Unexpected or Unanticipated Adverse Event is an event when the specificity or severity is not consistent with the research plan. (21 CRF 312.32 a) Related Adverse Event - where there is a reasonable possibility that the adverse event is caused by the research activity. (procedure, device, drug etc.) ANY ADVERSE EVENT THAT IS SERIOUS OR UNEXPECTED OR RELATED TO THE PROJECT MUST BE REPORTED. Check all that is appropriate: _____ Serious adverse events (may also need to be reported to sponsor of research). _____ Changes or deviations from the original IRB proposal/protocol taken to avoid or eliminate immediate hazards or risks to research participants. _____ Changes (maybe accidental or unintentional) that may increase risks or that may reoccur. _____ Publication in the field, safety report or finding that may indicate alteration from original risk/benefit ratio or a change in safety of procedure that may indicate increased risk. _____ Any adverse event occurring in the study that the Investigator suspects may be related to the study or research procedure. _____ Any unanticipated event related to safety of the research subjects. Describe the adverse event or an unanticipated event that may have caused risk to participants or others. Was this event (check all that apply) ___ unanticipated? ___ serious? ___ related to research procedures? Description of event: (attach pages as needed). If this event involved a death, indicate whether it is directly related to the project and how related. Date of event or period in which problem occurred: ______________________________ Number of Subjects enrolled to date: ______ Number believed to be at risk: _____ Is the potential for the event described in recruiting documents? ___Yes ___No Is the event or potential for the event described in the protocol? ___Yes ___No Is the event listed in the informed consent document? If not, has the informed consent document been modified to include this new information (attach old and new documents). If there is a rationale for not including this event in the informed consent, justify in detail. No new subjects may be enrolled until the new consent form is approved by the IRB. Is it necessary to inform subjects who have already consented to participation in the study of the adverse event? Explain. If yes, submit a new protocol for the study of the event for IRB approval. If particular subjects were involved, indicate subject numbers and ages (do not use names) or other identifiers. If particular subjects/participants cannot be identified than explain. If all participants are involved, please note. Identify interventions/treatments related to this problem. Identify any drug, biological or chemical agent(s) involved. Identify any institutions other than La Tech that are involved and explain involvement. (hospitals, schools etc.) Is there a safety monitoring board involved with research? Has the appropriate safety board been notified? If they have replied, please attach response. Has this event been reported to the research sponsor? If sponsor has responded, please attach reply. If un-sponsored research, indicate here. PI Respondent Only: If continued study participation is planned, please justify in detail. Explain how the approved protocol adequately minimizes risks and warrants continuation or if the protocol does not adequately minimize risks but should be continued. Please provide explanation. Is this the first time this has been reported to the IRB or is this a follow up report? If this is a follow up report indicate if this is the first or if other follow-up reports have preceded this one. Describe any changes since the last report.  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L^`LhH. ^`hH. ^`hH. PLP^P`LhH.Id}A          ο       vu{6 ,w @t* :SQ?yj|J<aMM~iXax-\X[(> .aSMje'`|!BQz%Mch5\b0WL@0`@UnknownG* Times New Roman5Symbol3. * ArialA BCambria Math"hf!2Fa  $ $!x24d2QHP ?qC2!xx2Report of Adverse events or Unanticipated ProblemsMary Margaret LivingstonBarbara Talbot  Oh+'0, DP p | 4Report of Adverse events or Unanticipated ProblemsMary Margaret LivingstonNormalBarbara Talbot97Microsoft Office Word@vl@L @ p՜.+,0 hp|  $  3Report of Adverse events or Unanticipated Problems Title  !#$%&'()+,-./0123456789:;<>?@ABCDFGHIJKLORoot Entry FP pQData "1Table*l$WordDocument4BSummaryInformation(=DocumentSummaryInformation8ECompObjy  F'Microsoft Office Word 97-2003 Document MSWordDocWord.Document.89q