THE PRINCIPLES OF ICH E6 GCP - f-mri.org

1 ICH E6 good clinical Practice1Dr Feldmann LucTHE PRINCIPLESOF ICH E6 GCP The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. clinical trials should be a detailed protocol E3. ICH E6 good clinical Practice2Dr Feldmann LucTHE PRINCIPLESOF ICH E6 GCP (IRB)/independentethicscommittee(IEC)app roval/favourableopinion.

2 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physicianor, when appropriate, of a qualified dentist. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). Freely given informed consent should be obtained from every subject prior to clinical trial participation. ICH E6 good clinical Practice3Dr Feldmann LucTHE PRINCIPLESOF ICH E6 GCP All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

3 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). Systems with procedures that assure the quality of every aspect of the trial should be implemented. ICH E6 good clinical Practice4Dr Feldmann LucIRB/IEC review board/independent ethics committee (IRB/IEC) should safeguard the rights, safety, and well-being of all trial subjects.

4 IRB/IEC should obtain : trial protocol(s) / amendment(s), written informed consent form(s), subject recruitment procedures, written information to be provided to subjects, Investigator's Brochure (IB), available safety information, information about payments and compensation available to subjects, the investigator s current curriculum vitae and/or other documentation evidencing qualifications. ICH E6 good clinical Practice5Dr Feldmann LucIRB/IEC , E6 good clinical Practice6Dr Feldmann LucINVESTIGATOR 'sQualificationsandAgreements (s)shouldbequalifiedbyeducation,training ,andexperiencetoassumeresponsibilityfort heproperconductofthetrial,shouldmeetallt hequalificationsspecifiedbytheapplicable regulatoryrequirement(s),andshouldprovid eevidenceofsuchqualificationsthroughup-t o-datecurriculumvitaeand/orotherrelevant documentationrequestedbythesponsor,theIR B/IEC,and/ortheregulatoryauthority(ies).

5 ICH E6 good clinical Practice7Dr Feldmann LucINVESTIGATOR 'sQualificationsandAgreements (s),asdescribedintheprotocol,inthecurren tInvestigator'sBrochure,intheproductinfo rmationandinotherinformationsourcesprovi dedbythesponsor. ,andshouldcomplywith, E6 good clinical Practice8Dr Feldmann LucINVESTIGATOR 'sQualificationsandAgreements ,andinspectionbytheappropriateregulatory authority(ies). E6 good clinical Practice9Dr Feldmann LucINVESTIGATOR E6 good clinical Practice11Dr Feldmann LucINVESTIGATOR (s)forwithdrawingprematurelyfromatrial,t heinvestigatorshouldmakeareasonableeffor ttoascertainthereason(s),whilefullyrespe ctingthesubject' E6 good clinical Practice12Dr Feldmann LucINVESTIGATOR ,oranalternativecontract, E6 good clinical Practice15Dr Feldmann LucINVESTIGATOR ,theinvestigatorshouldcomplywiththeappli cableregulatoryrequirement(s)

6 ,andshouldadheretoGCPandtotheethicalprin ciplesthathavetheiroriginintheDeclaratio nofHelsinki. ,northetrialstaff, E6 good clinical Practice16Dr Feldmann LucINVESTIGATOR ,includingthewritteninformedconsentform, shouldbeasnon-technicalaspracticalandsho uldbeunderstandabletothesubjectorthesubj ect'slegallyacceptablerepresentativeandt heimpartialwitness, E6 good clinical Practice17Dr Feldmann LucINVESTIGATOR ,theinvestigator,orapersondesignatedbyth einvestigator,shouldprovidethesubjectort hesubject'slegallyacceptablerepresentati veampletimeandopportunitytoinquireaboutd etailsofthetrialandtodecidewhetherornott oparticipateinthetrial.

7 Sparticipationinthetrial,thewritteninfor medconsentformshouldbesignedandpersonall ydatedbythesubjectandtheinvestigatorICH E6 good clinical Practice19Dr Feldmann LucINVESTIGATOR : (a)Thatthetrialinvolvesresearch. (b)Thepurposeofthetrial. (c)Thetrialtreatment(s)andtheprobability forrandomassignmenttoeachtreatment. (d)Thetrialprocedurestobefollowed,includ ingallinvasiveprocedures. (e)Thesubject' E6 good clinical Practice25Dr Feldmann LucINVESTIGATOR ,completeness,legibility,andtimelinessof thedatareportedtothesponsorintheCRFsandi nallrequiredreports.

8 ,thatarederivedfromsourcedocuments,shoul dbeconsistentwiththesourcedocumentsorthe discrepanciesshouldbeexplained. ,initialed,andexplainedandshouldnotobscu retheoriginalentry( );ICH E6 good clinical Practice27Dr Feldmann LucINVESTIGATOR ,auditor,IRB/IEC,orregulatoryauthority, E6 good clinical Practice28Dr Feldmann LucINVESTIGATOR (SAEs) , (s)relatedtothereportingofunexpectedseri ousadversedrugreactionstotheregulatoryau thority(ies)andtheIRB/IEC. E6 good clinical Practice31Dr Feldmann LucSPONSOR (CRO) 'strial-relateddutiesandfunctionstoaCRO, buttheultimateresponsibilityforthequalit yandintegrityofthetrialdataalwaysresides withthesponsor.

9 E6 good clinical Practice33Dr Feldmann LucSPONSOR ( ,clinicalpharmacologists,andphysicians)a sappropriate,throughoutallstagesofthetri alprocessICH E6 good clinical Practice37Dr Feldmann LucSPONSOR (s)/institution(s).Eachinvestigatorshoul dbequalifiedbytrainingandexperience. E6 good clinical Practice39Dr Feldmann LucSPONSOR ,thecodingsystemfortheinvestigationalpro duct(s)shouldincludeamechanismthatpermit srapididentificationoftheproduct(s)incas eofamedicalemergency, E6 good clinical Practice40Dr Feldmann LucSPONSOR (s)/institution(s)providedirectaccesstos ourcedata/documentsfortrial-relatedmonit oring,audits,IRB/IECreview,andregulatory inspection.

10 ,inwriting,todirectaccesstohis/herorigin almedicalrecordsforICH E6 good clinical Practice43Dr Feldmann LucMONITOR Purpose Thepurposesoftrialmonitoringaretoverifyt hat: (a)Therightsandwell-beingofhumansubjects areprotected. (b)Thereportedtrialdataareaccurate,compl ete,andverifiablefromsourcedocuments. (c)Theconductofthetrialisincompliancewit hthecurrentlyapprovedprotocol/amendment( s),withGCP,andwiththeapplicableregulator yrequirement(s).ICH E6 good clinical Practice44Dr Feldmann LucMONITOR Selection and Qualifications of Monitors (a)Monitorsshouldbeappointedbythesponsor .