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1、临床研究协调员-培训-资料--Clinical-research-coordinator-CRC-training-documents--DEC-————————————————————————————————作者：————————————————————————————————日期：ClinicalresearchcoordinatorTheClinicalResearchCoordinator(CRC)isresponsibleforconductingclinicaltrialsusinggoodclinicalpract
2、ice[1](GCP)undertheauspicesofthePrincipalInvestigator(PI).GoodClinicalPracticesPrincipleshavebeendefinedbyMadeleneOttosen,RN,MSN,ofTheUniversityofTexasHealthScienceCenteratHouston[1]as:·Alltrialsareconductedethically,asdefinedbytheDeclarationofHelsinki,rigorously,asd
3、efinedbytheInternationalConferenceonHarmonizationGuidelines[2](ICH).·Benefitsoutweighrisksforeachpatient.·Rights,safetyandwell-beingofpatientsprevailoverscience.·Allavailablenon-clinicalandclinicalinformationonanyinvestigationalagentcansupportthetrialasdesigned.·Allt
4、rialsarescientificallysoundandclearlydescribed.·AllclinicaltrialshavecurrentInstitutionalReviewBoardapproval.·Medicaldecisionsandcarearetheresponsibilityofqualifiedhealthcareprofessionals,specificallyphysiciansand,ifapplicable,dentists.·Everyoneinvolvedintheclinicalt
5、rialisqualifiedbytraining,educationandexperience.·Informedconsentisgivenfreelybyeveryparticipant.·Allstudydocumentationisrecorded,handledandstoredtoallowaccuratereporting,interpretationandverification.·Confidentialityofsubjectsisrespectedandprotected.·Investigational
6、productsmaintainGoodManufacturingPracticeinstorage,manufacturingandhandling.·Systemstoensurequalityareimplementedinallaspectsofthetrial.AlthoughthePIisresponsiblefortheconductofthetrial,“ithasbeensaidthattheCRCistheheartandsouloftheresearchstudyandthat,ultimately,iti
7、stheCRCwhocarriesforwardtheresearchgoals,therebyplayingasignificantroleinthesuccessoftheresearchstudy.Mostimportantly,CRCsareofteninvolvedinessentialdutiesthathavebeentraditionallyperformedbythePI,suchasconductingtheinformedconsentprocessandensuringcompliancewiththep
8、rotocol”.[2]TheCRC’sprimaryresponsibility,aswithallclinicalresearchprofessionals,istheprotectionofhumansubjects,buttheCRChasmanyoth
