ࡱ> U@ tbjbj x<#d4444h.55\ o2"6f:::;;F?>$c?mmmmmmmRpRrmFA;;FAFAm:;nFFFFAX:;mFFAmF(FFhDp6k:|6 pR<4A|i&mn0 o j6sB~6sLk6skT?0'@"FI@e@???mmd> F> APPEndix 8: DATA SAFETY AND MONITORING PLAN If you have any questions about preparing your data and safety plan, please contact one of the GCRC Research Subject Advocates at 982-4311 or 924-5492.  FORMCHECKBOX  Cancer Center Study-DSMP will be reviewed, approved and monitored by the Cancer Center DSMC. Please attach the Cancer Center DSMP  FORMCHECKBOX  Industry initiated/sponsored trial attach the DSMP from their protocol and do not complete this form. STUDY INFORMATION Vulnerable Populations: Check all populations that may be part of the study. Level of risk may increase depending on procedures completed in the following populations.  FORMCHECKBOX  Minors under age 18  FORMCHECKBOX  Cognitive impairment  FORMCHECKBOX  Language barrier  FORMCHECKBOX  Terminal Illness  FORMCHECKBOX  Sensitive Information Recorded  FORMCHECKBOX  Progressive Disease  FORMCHECKBOX  Rare Disease  FORMCHECKBOX  Physical Impairment  FORMCHECKBOX  Pregnant Women  FORMCHECKBOX  Fetus/Fetal Tissue  FORMCHECKBOX  Prisoners  FORMCHECKBOX  Other vulnerable population (describe):  FORMTEXT         FORMCHECKBOX  Study is eligible for expedited HIC review (See HIC web site if unsure whether study can be expedited:  HYPERLINK "http://www.irb.virginia.edu/HICDocs/SOP" www.irb.virginia.edu/HICDocs/SOP STOP: If eligible for expedited review do not complete the rest of this form. DSMP for expedited studies will be as follows: Monitoring will be performed by the PI and HIC through annual review. No adverse events are anticipated, but should they occur they will be promptly reported to the HIC and the GCRC-RSA. Any serious adverse events will require reevaluation of the risk of the study. Check all that apply:  FORMCHECKBOX  Low risk intervention in a population at risk for serious clinical events based on underlying disease  FORMCHECKBOX  Intervention of undefined risk or intervention with low frequency of serious adverse events  FORMCHECKBOX  An approved drug with a well-known adverse event profile, and includes physiologic measurements that carry little risk to the participant or blood sampling.  FORMCHECKBOX  Intervention associated with risk of serious adverse events at high or uncertain frequency  FORMCHECKBOX  Experimental therapies will be administered including all new drug INDs or investigational device exemption  FORMCHECKBOX  Study involves population with very high risk of serious adverse clinical events based on underlying disease or in whom assessment of treatment associated adverse events may be difficult  FORMCHECKBOX  Gene transfer study  FORMCHECKBOX  Other: (describe)  FORMTEXT       ADVERSE EVENT CAPTURE AND REPORTING Description of anticipated adverse events: (copy from the consent form and paste in field ()  FORMTEXT       Description of a structured adverse event determination and reporting system How will you define adverse events?  FORMCHECKBOX  An adverse event will be considered any undesirable sign, symptom or medical condition occurring after administering the investigational drug/intervention even if the event is not considered to be related to the investigational drug/intervention. Medical condition/diseases present before starting the investigational drug/intervention will be considered adverse events only if they worsen after starting study treatment.  FORMCHECKBOX  Other: (describe)  FORMTEXT       How will you define serious adverse events?  FORMCHECKBOX  A serious adverse event is defined as an undesirable sign, symptom, or medical condition which is fatal, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, constitutes a congenital anomaly or a birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment. ALL SERIOUS ADVERSE EVENTS WILL BE REPORTED WITHIN 24 HOURS OF NOTICE TO THE HIC, GCRC-RSA AND APPROPRIATE SPONSORS.  FORMCHECKBOX  Other: (describe)  FORMTEXT       3) How will AEs be classified/graded?  FORMCHECKBOX  Utilizing the mild, moderate, severe criteria: Mild adverse event (AE)-did not require treatment Moderate AE-resolved with treatment Severe AE-resulted in inability to carry on normal activities and required professional medical attention  FORMCHECKBOX  World Health Organization Toxicity Criteria  FORMCHECKBOX  CTEP Common Toxicity Criteria, version 2.0 (http://ctep.cancer.gov/reporting/ctc.html)  FORMCHECKBOX  Other: (specify)  FORMTEXT       Identify the attribution scale to be used in this study.  FORMCHECKBOX  The PI will determine the relationship of adverse events to the test procedure/device/agency using the following scale: Definite: AE is clearly related to the investigational agent/procedure Probable: AE is likely related to the investigational agent/procedure Possible: AE is may be related to the investigational agent/procedure Unlikely: AE is doubtfully related to the investigational agent/procedure Unrelated: AE is clearly not related to investigational agent  FORMCHECKBOX  The PI will use an alternative attribution scale (specify)  FORMTEXT       All studies utilizing the GCRC will report adverse events as follows: Unexpected Event Expected Event RATED MODERATE (Grades 2  3) Attribution of Possible, Probable or Definite RATED SEVERE (Grade 4) Regardless of Attribution RATED MILD OR MODERATE (Grades 1 3) RATED SEVERE (Grade 4) Regardless of Attribution Report within 10 working days to GCRC-RSA.  Report to GCRC-RSA within 10 working days.  Adverse Event Expedited Reporting NOT required. Rreport within 10 working days to GCRC-RSA.  Description of Protocol Specific Data Capture: How will the adverse event data be collected?  FORMCHECKBOX  AE forms (attach)  FORMCHECKBOX  Protocol specific case report forms (attach)  FORMCHECKBOX  Other: (specify)  FORMTEXT       How will adverse events be captured? (Check all that apply)  FORMCHECKBOX  Lab tests/physical exam  FORMCHECKBOX  GCRC nursing flow sheets  FORMCHECKBOX  Patient interviews  FORMCHECKBOX  Phone follow-up  FORMCHECKBOX  Other: (specify)  FORMTEXT       3) List by table or bullet format a summary of safety tests to be collected. Particularly list those tests or procedures that screen out ineligible research subjects and those that monitor for toxicity and other adverse outc /^ _ ` n o p   ƻƴ񪢚ujjh*Uj^h*U h!jh5jh*Ujh5UhWh@Y6h!jh@Y5h!jh@Y5>* h!jh/>jth*Uh/>jh/>Ujh*Uh@Yjh@YUh?gh@Y5 h!jh@YhWh5)./_ , ] X $Ifgd@Y $Ifgd5gd@Y >^`>gd@Ygd@Ygd5gd5stt     , - ; < = > ] ^ l m n o " > @ B D X Z v x jh*Uj~h*Ujh*Ujh*Ujh*Ujh*Uj0h*Ujh*UjFh*Ujh5U h!jh5h56x z |    6 v 678XY[c|wogh/>h@Y6h/>h/>6 h/>5 *h/>h/>5h [h/>0Jjh/>Ujh/>Uh/>h%Zj]h*Uh@Yjh@YU h!jh@Yjh*UmHnHujjh+_h5Uh!jh56 h!jh5h5jh5U&X \|tttt h^h`gd@Yh^hgd@Y h^h`gd/>gd@YQkd$$Ifl0\(dd t644 la $Ifgd@Y $Ifgd5 |}RSabcdwxy돋j h*UhyjhyUj h*Uj& h*Uj h*Uj: h*Uj h*UjN h*U h!jh@Yjh*Uh@Yjh@YUh/>h/>52RxZ\DFHnpB ^`gdg & F gd@YgdOzgd$?Xgd@Ygd@Y h^h`gd@Y  \246@BDFH}rk]rrYTOGhOzhOz\ hOz>* h@Y>*h$?Xj h^h$?XU h^h$?Xjh^h$?XUh$?X56B*phh$?XB*ph$ jh^h$?X56>*B*phh$?X56>*B*phh!jh$?X56>*B*ph h$?X5h!jh$?X5 h!jh@Y h!jhyjh*UmHnHujhyUj h\ wUhy%&'(prABCQRSTeghrs  `b~آ|jh+_h@YUjLh*UhOzh@Y5 hOz5hOzjh*Ujh*UmHnHujbh+_h@YUj h*U h!jh@Yjv h*Uh@Yjh@YUh!jh@Y560^`F67u  !"a""":#;#$ ^`gd@Y 8^8`gd@Y & F gd@Yh^hgdg^gd@Y & Fgdh^hgd@Ygd@Y~FV78FGHIuv  ;#<#J#ݷ}jh*Ujh*UmHnHujh+_h@YUh!jh@Y6jh*Uj"h*UjhgUjh*Uh!jh@Y>*hg h!jh@Yh@Yjh@YUj6h*U0J#K#L#M########$ $ $$$$*$$$$$$$$$$$$$% % %%"%$%%%%%% & &&&&᪞thOz5:CJaJhOz5CJaJh!jh@Y5h^h@Y5:CJaJh^h@Y5CJaJh^h@YCJaJhOzh?gjh*UmHnHujnh+_h@YUh!jh@Y6 h!jh@Yh@Yjh@YUjh*U-$$$$$$$$$$$&%%%%%%%Ekd$$IfH0n%n4 HaH d$Ifgd@Y d$Ifgd@Ygd"mgd@Y% &&&*&4&N&O&P&{&|&}&|sg $$Ifa$gd@Y $Ifgd@Ykkd]$$IfH\Kn%K#  4 HaH d$Ifgd@Y d$Ifgd@Y &&*&+&,&0&3&N&O&P&Q&z&~&&&&&&' ' ';'<'k'l'z'{'|'''''''''''···~vrgvr_vh!jh@Y6j!h*Uh@Yjh@YUhh@Y6jh*U hh@Yjhh@YUhOzh@Y5 hOz5 h!jh@Yh^h@YCJaJ *h^h@YCJaJ *hOzCJaJh!jh@Y5hOz5:CJaJh^h@Y5CJaJhOz5CJaJ%}&~&&&&&&& ' ' ' 'akkd$$IfH\Kn%K#  4 HaH $IfgdE d$Ifgd@Y $Ifgd@Y $Ifgd@Y d$Ifgd@Y ' '<'j'k'''(((((8)))8*:*4T8Tgd"m h^h`gd@Y^gdgd@Y & F gd@Y gd@Y^gd  & F gd@Y ^gd@Y^gd@Y'''''''''''( ( (\((((((((()))8):)V)X)Z)\))))))))))))ڱxmjYh*Ujh*Ujmh*Ujh*Ujh*h*5Uhh@Y5jhh@Y5Ujh*UmHnHuj h+_h@YUh!jh@Y6 h!jh@Yjh@YUjh*Uh@Y*))) ***&*(***4*6*8*:*,T T TT"T$T&T0T2T4T6T,U.U0UDUFUHURUTUUVVVVV$V&V*VVVVVVVpW|jh*Uh!jh@YB*phj-h+_h@YUjh+_h@YUh?gjCh+_h@YUU h+_h@Yjh*UmHnHujh+_h@YUjh@YUh!jh@Y6 h!jh@Yh@Y0omes.  FORMTEXT       Describe Criteria for stopping or modifying treatment in individual participants, and for early termination of the study.  FORMTEXT       If applicable, describe the criteria for breaking the blind for randomized trials?  FORMTEXT       How will subject withdrawals/dropouts prior to study completion be reported:  FORMCHECKBOX  Annual review summary to HIC with a copy to the DSMC if applicable  FORMCHECKBOX  Other type of list/form (please attach) The PI, along with the investigative staff, will review all adverse events as they occur in each subject. SAFETY MONITORING 1) Who will provide oversight for the safety monitoring plan of this study? (Check all that apply)  FORMCHECKBOX  Principle Investigator  FORMCHECKBOX  A designee (complete question a below)  FORMCHECKBOX  The internal UVa GCRC Safety Monitoring Committee (SMC)  FORMCHECKBOX  A sponsor identified committee or medical monitor (complete question b below)  FORMCHECKBOX  An independent/external data and safety monitoring board (complete question b below)  FORMCHECKBOX  Other (specify)  FORMTEXT       Identify the designee: (list name, qualifications and role on project):  FORMTEXT       Name of the DSMB: Explain composition of the members and their affiliation with the sponsor: (Attach policies of the Board)  FORMTEXT       2) How often will the responsible oversight body or person review safety?  FORMCHECKBOX  As adverse events occur  FORMCHECKBOX  Ba8TVUXU(V*VVVpWWW]X^X_XqXrXXXY9YYZh^hgd c ^`gd5 ^`gd c^gd c^gd cgd@Yh^hgd@Ygd@Y & F gd@YpWrWWWWWWWW]X_XrXvXXXXXXXXXXYYYYYY0Y1Y8Y9Y:YHYIYJYKY~YYYYYYYYYYYYYͲh?<h?<6jh*UhOzj{h*Uh5jh*Ujh*Ujh cUh!jh c6h ch!jh@Y5h!jh@Y6 h!jh@Yjh*Uh@Yjh@YU1YYYYZZZZZZZZZZZZZZZ[[[[ [[[[[[[[[\\\\\\\\\\P]~]]ɨyuyh$k hh@Yh?<j? h+_h@YUjh+_h@YUh!jh?g6 h@Y6jh*UmHnHujSh+_h@YUh!jh@Y6jh*U h?<6 h!jh@Yh@Yjh@YUjgh*U,Z[[ [[[[\\\\]]$hXhhhTiViiTjjh^hgd?<h^hgd cgd?<h^hgd@Ygd@Y & Fgd@Y hh^h`hgd@Y ^`gd5]]]]]]]]]]]]^h"h$h&hBhDhFhHhXhZhvhxhzhhhhhhhhhhhiiiii(i,i.iBizrh!jh@Y6j#h*Uj"h*U h!jh?<j"h*Uh?<jh?<U h!jh@Yj!h*Uh@Yjh@YUUj+!h*U h!jh cj h*Uh cjh cUh!jh@Y5,sed on enrollment  FORMCHECKBOX  Monthly  FORMCHECKBOX  Once every six months  FORMCHECKBOX  Once a year  FORMCHECKBOX  Other: (specify)  FORMTEXT       3) What will be reviewed? 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