Harmonization of the Practice of Independent Ethics Committees in Italy Project E-Submission 英文参考文献.docVIP

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Harmonization of the Practice of Independent Ethics Committees in Italy Project E-Submission 英文参考文献.doc

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Harmonization of the Practice of Independent Ethics Committees in Italy Project E-Submission 英文参考文献

HarmonizationofthePracticeofIndependentEthics CommitteesinItaly:ProjectE-Submission GianfrancoDeFeo1*,GiacomoChiabrando2,NunziaCannovo3,AntonioGalluccio4,CarloTomino4 1NationalCancerInstitute, Naples,Italy, 2S.OrsolaUniversityHospital, Bologna, Italy,3EthicsCommitteeof‘‘Federico II’’University, Naples,Italy, 4Italian Medicines Agency,Rome,Italy Abstract Aim:Thehighvariabilityof‘‘centre-specific’’documentationrequiredbyIndependentEthicsCommittee(IEC)playsarolein thetimerequiredforactivationofparticipatingcentresofmulticentreclinicaltrials.Thisstudy(a)providesapictureofthe differentactivities,structuralrequirementsandresourcesdedicatedtotheoperationofthelocalIECinItaly;(b)definesa detailed list of ‘‘centre-specific’’ documents considered as essential by the IEC for issuing its opinion and (c) suggests a ‘‘singledocument’’toreducethevariabilityofthe‘‘centre-specific’’documentsrequiredbytheIEC. Methodology:TwosurveyswereconductedthroughtheportalofNationalMonitoringCentreofClinicalTrials(https://oss- sper-clin.agenziafarmaco.it/).ThefirstsurveyfocusedonthelocalIECresourcesandonthe‘‘centre-specific’’documentation that local IEC required from the Sponsor and local Principal Investigator (PI). The second focused on ‘‘single document’’ required in the form of statements from the Sponsor and the PI. Answers were discussed and extended during regular scheduledteleconferencesandplenarymeeting. PrincipalFindings:From22/07/2009to15/12/2009,andfrom19/04/2010to14/05/2010,131and125IECsrespondedto the first and the second surveys, respectively. 67% and 51% of IECs consider the structural requirements and the staff dedicatedtotheactivityoftheIECsassufficient,respectively.MostoftheIECsconsiderthe‘‘centre-specific’’documentation asnecessaryforissuingtheopinion,andahighpercentageofIECsconsidertheproposeddocumentationasacceptablein substitutiontoanyother‘‘centre-specific’’documentationalreadyinuse. Conclusions:TheharmonizationofIECspracticeinItalyisthefirststeptofacilitatemulticent