ࡱ> 796` bjbj ; r /ZZZZZZZn   8N Z ,n 4  npppppp$hCpZ ZZ XZ Z nn"ZZn 0l d:0B,cnZn, Z6 @v 4 EX nnnD dnnn nnnZZZZZZ Department of Veterans AffairsMemorandum Date: Dec 2, 2004 From:Associate Chief of Staff, R&Dfillin "FROM - Title and routing Symbol" Subj:Reporting of all Study Site-Monitoring Visit Resultsfillin "SUBJECT of the memorandum" To: Thru:All Principle Investigators and Research Staff Research Compliance Office, R&Dfillin "TO - Title and routing Symbol" Effective immediately, the following guidelines are to be implemented for each study that is monitored by a pharmaceutical company or Contract Research Organization (CRO): The Research Compliance Officer is to be notified of all monitoring visits by pharmaceutical companies or CROs as soon as possible. This is the responsibility of the research staff person who schedules or confirms the monitoring visit. If the monitoring visit is unscheduled, the Research Compliance Officer or R&D Office is to be notified as soon as the study personnel are aware of the visit. The Research Compliance Officer will arrange a convenient time to meet with the Monitor. The CRO or study monitor must sign in as a visitor with the Research Office as required of all visitors to research areas. An ID badge must be presented and worn. The Principal Investigator or other responsible investigator is to meet with the study monitor(s) prior to the monitors beginning their work. During each visit by a monitor, the role of the monitor should be reviewed, including the new requirement that any potential or actual serious findings be conveyed to the investigator and the Research Compliance Officer (RCO), during an exit interview. Findings that require an exit interview include but are not limited to: Any suspicions or concerns that serious non-compliance may exist, and All findings of serious non-compliance with the study protocol, IRB requirements or applicable regulations and policies (e.g., failure to consent subjects, entering subjects who do not meet entrance criteria into protocols, failure to report serious or unexpected adverse events). If the monitor records no serious findings or concerns as listed above, the study investigator or research coordinator must notify the RCO in writing that there were no such findings identified by the monitor. If you have any questions regarding the implementation of these procedures, please do not hesitate to contact the Research Compliance Officer at x5542 fillin "Chief or Sender's Name"     PAGE2 VA FORM 2105 Automated *,3AGdeJ K q r PQpqrsuvxy{|~ҴҴҴҴ¦ҴҴҴҴҞ~h_5B* CJOJQJphh_jh_Uh[YOjh[YOUhH]pB* OJQJ^JphjhH]pOJQJU^JhH]pB* CJOJQJ^JphhH]pOJQJ^J"hH]p5B* CJ<OJQJ^Jph"hH]p5B* CJOJQJ^Jph.*+,3? d$If $d$Ifa$dJkd$$Ifl400$$HH4 laf4 $$Ifa$$Ifr?@AGSHkd$$IfH40H$$4 Ha0f4 d$If $d$Ifa$dHkd[$$IfH40 4 Ha0f4+ s t u ! SQHkd$$IfH40H$$4 Ha0f4 d$If $d$Ifa$dHkdA$$IfH40H$$4 Ha0f4 ! " MNOPrtuwxz{}~$a$h^h & F & F9 0 00(PP/ =!"#$% Y$$If!vh5H5H#vH:V l405H4f4q$$If0!vh55#v#v:V H45544 Ha0f4q$$If0!vh55$#v#v$:V H455$44 Ha0f4q$$If0!vh55$#v#v$:V H455$44 Ha0f4q$$If0!vh55$#v#v$:V H455$44 Ha0f4<@< NormalCJ_HmH sH tH DAD Default Paragraph FontVi@V  Table Normal :V 44 la (k(No List 4 @4 Footer  !4@4 Header  !H@H  Balloon TextCJOJQJ^JaJ  *+,3?@AG+stu!" M N O P r t u w x z { } ~ 00 0 0000 0 000 0000 0000 00 0000 0 0 0 0 0 000000@0ي00@0ي00@0ي00@0ي00@0@0@0@0ي00*+?@st ۊ0Xي0 ۊ0ي0 ۊ0ȷي0 ۊ0ي0 ۊ0 8ي0  .1 ?!   dJqP p '''' 1!alBbc|=AdLBe-BfL6A3j >m 8*urn:schemas-microsoft-com:office:smarttagsdate?*urn:schemas-microsoft-com:office:smarttags stockticker 9 1222004DaylsMonthtransYearr r t t u u w x z { } ~ X]r r t t u u w x z { } ~ 338G_d+r/9<W[[_f  $jm L O O P q r r t t u u w x z { } ~ Aup<h ^`o(hH. ^`hH. pLp^p`LhH. @ @ ^@ `hH. ^`hH. L^`LhH. ^`hH. ^`hH. PLP^P`LhH.Au         [YOHreRfH]p_*+,3?@AGstr t w z } @[[W[[ `@UnknownGz Times New Roman5Symbol3& z Arial5& z!Tahoma Vhij&*fJ h h YV4dn n 2QVHX ?Hre2BC:\DOCUME~1\VHABIL~2\LOCALS~1\Temp\FrontPageTempDir\Memorandum.dotIMemorandum: One Addressee - VA Form 2105 Automated (Word for Windows) VHABILBurnsM VHANFLHEINES Oh+'00 HT t   LMemorandum: One Addressee - VA Form 2105 Automated (Word for Windows)VHABILBurnsM MemorandumVHANFLHEINES4Microsoft Office Word@e@ 5@AL@NQh ՜.+,0L hp  . Department of Veterans Affairsn  JMemorandum: One Addressee - VA Form 2105 Automated (Word for Windows) Title  !"#$%'()*+,-/0123458Root Entry Fl:Data 1TableWordDocument; SummaryInformation(&DocumentSummaryInformation8.CompObjq  FMicrosoft Office Word Document MSWordDocWord.Document.89q