Transcription of Good Clinical Practice - ICSSC
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Good Clinical Practice - ICSSC
good Clinical Practice1 Quality Control and Quality Control and Quality Assurance Quality Assurance DMID/ICSSCDMID/ICSSC10-07-08 good Clinical Practice2 Quality Control and Quality AssuranceQuality Control and Quality AssuranceQuality Control (QC)Daily, ongoing, real time review of site s work processes to ensure that procedures are being followedExample:QC is performed on 100% of CRFs prior to entry into the databaseGood Clinical Practice3 Quality Control and Quality AssuranceQuality Control and Quality AssuranceQuality Assurance (QA)A periodic, planned, objective review of research related activities to ensure compliance with GCP and other regulatory requirementsExample:A monthly review of source documents and CRFs to ensure agreementGood Clinical Practice4 Quality Control and Quality AssuranceQuality Control and Quality AssuranceQuality Management (QM) The overall process for assessing quality and encompasses both quality controlandquality assuranceQM = QC + QAGood Clinical Practice5 Quality Control and Quality AssuranceQuality Control and Quality AssuranceICH E6 is responsible for qualitySponsor must implement and maintain QC and QA systems with written SOPsSo what systems has the sponsor got in place?
Good Clinical Practice 7 Quality Control and Quality Assurance Clinical Quality Management Plan ¾A written document ¾ Details frequency and sample size of QA and QC activities; lists who is responsible
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