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Basic Principles of Clinical Research and Methodology
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ISBN
:
9788184480863
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Publisher
:
Jaypee Brothers Medical Publishers (p) Ltd.
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Subject
:
Medical Study & Revision Guides & Reference Material
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Binding
:
Paperback
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Pages
:
516
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Year
:
2007
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Description
Table of ContentsClinical Research–Past, Present and FutureDrug Development and DiscoveryDesigning Clinical TrialsEthical Issues in Clinical ResearchICH-GCP GuidelinesInformed Consent Process: Protecting Subjects RightsRole of CRC and CRA in Clinical TrialsProtocol DesigningSponsor’s and Investigator’s ResponsibilitiesPatient Recruitment and Retention in Clinical TrialsProject Management in Clinical TrialsPharmacovigilance in Clinical ResearchRole of Contract Research Organization in Clinical Research ManagementOutsourcing Clinical ResearchBiostatistics in Clinical TrialsBioequivalence Studies in Drug DevelopmentFinance and Budgeting in Clinical TrialsClinical Data ManagementClinical Trials for Herbal Drugs and Traditional Medicines Investigational New Drug ApplicationsCase Report FormClinical Trial LogsStandard Operating ProceduresAudits and Inspections in Clinical Trials Fraud and Misconduct in Clinical ResearchAn Introduction to Medical Writing Communication SkillsRequirements and Guidelines to Undertake Clinical Trials in India Schedule Y (Amended Version)APPENDIX I: Data to be Submitted along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in the CountryAPPENDIX I-A: Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in the Country Index
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