Cdsco gcp different secctions
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Cdsco gcp different secctions

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Cdsco gcp different secctions Cdsco gcp different secctions Presentation Transcript

  • CDSCO-GCP DIFFERENT SECCTIONS BY RAHUL challarahul77@gmail.com
  • 1.DEFINITIONSGood Clinical Practice is a set of guidelines for biomedical studies of design,conduct, termination, audit, analysis, reporting and documentation of thestudies involving human subjects.It aims to ensure that the studies are scientifically and ethically sound andthat the clinical properties of the pharmaceutical substances underinvestigation are properly documented.2.PRE-REQUISITESInvestigational Pharmaceutical Product.Pre-clinical supporting data.ProtocolEthical & Safety Considerations
  • 3.RESPONSIBILITIESSponsorThe MonitorInvestigator4.Records & DataDocumentationCorrectionsElectronic Data ProcessingValidation of Electronic Data Processing Systems
  • 5.QUALITY ASSURANCEThe Sponsor is responsible for the implementation of a system ofQuality Assurance .The data is generated, recorded and reported in compliance with theProtocol, GCP and other applicable requirementsQuality control must be applied to each stage of data handling toensure that all data are reliable and have processed correctly.6.STATISTICS Statistical Analyses to be used must be clearly identified and shouldform basis of the statistical model for the Study.Role of BiostatisticianStudy designRandomisation and BlindingStatistical Analysis
  • 7.SPECIAL CONCERNSThe sponsor and investigator should be aware of the approval processinvolved in conducting clinical trials of vaccines. Research should beperformed on patients undergoing the procedures for diagnostic ortherapeutic purposes.Clinical Trials of Vaccines Clinical .Trials of contraceptives Clinical .Trials with Surgical Procedures / Medical devices.Clinical Trials for Diagnostic agents – Use of radioactive materials and X-raysClinical Trials of Herbal Remedies and Medicinal Plants.