分析案例教案译文4mandy en10451100good clinical practice.pptx

Good Clinical Practice (inclusion of ICH/GCP E6 R2) Mandy YuClinical Operation Leader, Syneos HealthObjectivesBy the end of this training you should be able to explain:What is Good Clinical Practice (GCP)?Why is GCP important?How does GCP apply to my clinical trial?What does GCP require of an investigator?What are the consequences of noncompliance?How do I prepare for an audit or inspection?What are the most common noncompliances noted at investigator sites?Regulatory RequirementsInternational Conference on Harmonization Guidelines for GoodClinical Practice (“ICH GCP E6 R2”)Title 21 Code of Federal Regulations (21 CFR): FDA-Regulated ProductsPart 11: Electronic Records/Electronic SignaturesPart 50: Protection of Human SubjectsPart 54: Financial Disclosure by Clinical investigatorsPart 56: Institutional Review Boards Part 312: Investigational New Drug Application (IND)Additional Guidance- FDA Information SheetsCountry-specific lawsWhy Is GCP Important?International ethical and scientific quality standards for the design, conduct, monitoring, recording and reporting of clinical trialsCompliance with these standards assures:- Rights, safety, confidentiality and well-being of participants are protected- Credible and accurate data are reportedApplication of GCP to Your TrialIt is highly possible that data from this clinical study will be reviewed by regulatory authoritiesAs part of this review process, regulatory authorities will look for compliance with or equivalence to:21 CFR Parts 11, 50, 54, 56, 312Good Clinical PracticeThe current protocolOther applicable regulationsInvestigator Roles and ResponsibilitiesQualified by education, training, and experienceThoroughly familiar with protocol, safety information, and investigational productProtect the rights, safety and welfare of subjects under the investigator’s careComply with GCP and regulatory requirementsProvide adequate oversight and supervision of staffMaintain list of site personnel who will perform specific trial