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- W1497465024 abstract "Clinical Research - A Clinical Investigator's Perspective Introduction Scientific and Practical Aspects Financial Considerations Medical Device Development, Process and Regulation Introduction Categories of Medical Devices Evaluation of Medical Devices Regulatory Process Pre-Clinical Drug Development Introduction Overview of Drug Discovery and Role of basic Sciences New Approaches in Drug Discovery Pharmacological Screening Phases of Clinical Trials Introduction Phase I Phase II Studies Phase III Trials Phase IV Trials Phase 0 - Microdosing Studies Introduction Micro-dosing and Exploratory-IND Studies Characteristics of an Ideal Candidate Drug for Phase 0-Micro-dosing Studies Goals of Microdosing Studies Technical Advances Regulatory Issues Patient's Perspective Informed Consent Issues Single-dose Toxicity Study in Support of Micro-dosing Studies Advantages of Micro-dosing Limitations of Micro-dosing Conclusion Clinical Research Planning Introduction to Clinical Trials Types of Clinical Trials The Planning Steps Clinical Research Design Introduction Elements of Trial Design Types of Clinical Trial Design Clinical Research Protocol Title Page Signature Page Contents Page List of Abbreviations and Definitions Summary Background Trial Objectives and Purpose Study Design Subject Selection Subject Recruitment Trial Interventions Randomisations Blinding Data Statistical Considerations Compliance and Withdrawal Interim Analysis and Data Monitoring Ethical Considerations Financing and Insurance Reporting and Publication Designing Case Report Forms Introduction Uses of CRF Well-Designed CRF CRF Design Layout CRF Field Designs CRF Verification Before Use Elements of Trial Design Electronic Data Entry Forms Conclusion Points to Remember Process of Randomization in Clinical Trials Introduction Advantages of Randomization Types of Randomization Techniques of Randomisation Implementation of Randomization Procedure Investigational Medicinal Products Definition Manufacturing, Packaging, Labeling, and Coding IMPs Supply and Handling IMPs Receipt of IMP, Inventory, Storage and Accountability Randomization Code Principles Applicable to Comparator Product Blinding Operations Recall, Return, Shipment and Destruction of IMP Multi-center Clinical Trials Introduction Advantages and Disadvantages A Common Protocol A Coordinating Centre Comparability of Participating institutions Committees in a Multi-center Trial Statistical Issues Analysis of Results Multinational Clinical Trials Good Clinical Research Practice Introduction Definition of GCP Overview of the Clinical Research Process Principles of GCP Role and Responsibilities of Sponsor Introduction Contract Research Organization (CRO) The Sponsor and the investigational Products Sponsor and Record Access Safety Information Role and Responsibilities of Principal Investigator Introduction Competencies and Responsibilities of the Principal Investigator Qualifications and Availability Adequate Resources Informed Consent Investigational Products Compliance with Protocol Monitoring and Auditing Source Data and Other Documentation Safety Issues and Reporting of Serious Adverse Events Premature Termination - Breaking the Treatment Code Progress Reports, Trial Outcome and Final Study Reports Ethical Consideration in Clinical Research - Special Reference to Developing Countries Introduction Individuals Involved With Ethical Issues Ethical Issues Related to Protocol Development and Study Design Issues on Informed Consent Ethical Issues During Conduct of a Clinical Research Access to Post Trial Benefits Need for Developed Countries to Assist Developing Countries in Capacity Building Informed Consent in Clinical Research Introduction Historical Background Elements of Informed Consent Language Used in Consent Forms Informed Consent Waiver Revising an Informed Consent Reconsenting Process Consent Obtained from Special Groups of Patients Monitoring in Clinical Trials Introduction Types of Monitoring in Clinical Trials Key Participant in Monitoring of Clinical Trial Quality Assurance in Clinical Research Monitoring-Details Presented in Chapter on Monitoring Audit Inspections Data Management Metrics Pharmacovigilance and Drug Safety Introduction Terms Commonly Used in Drug Safety The Specific Aims of Pharmacovigilance Definitions ADR Classification and Evolution Causality Assessment Scales Important of Post Marketing Surveillance and ADR Reporting Characteristics of a Good Adverse Drug Reaction Report Periodic Safety Update Report (PSUR) MedDRA or Medical Dictionary for Regulatory Activities Pharmacovigilance in India Data and Safety Monitoring Board and Monitoring Plan Definition and Purpose Data Monitoring Committee Data Safety Monitoring Plan Standard Operating Procedures Introduction Standard Operating Procedures SOP Template Master Formulation Record Archiving Clinical Research Documents Introduction Stake Holders What Documents Must Be Archived How long Should the Documents be Archived When to Archive Trail Master File (TMF) The Archive Building Evidence Based Medicine Introduction and Overview History Types of EBM Categories of Evidence Categories of Recommendations Statistical Measures Quality of Clinical Trial Publications Limitations of Available Evidence Criticism of Evidence-Based Medicine Clinical Research Data Management Introduction Protocol Randomisation Data Management Final Study Report Retension and Securing of Records Archiving by the Principle Investigator Archiving by the Sponsor Clinical Biostatistics (a) Biostatistics for Clinical Researcher 26(a).1 Introduction 26(a).2 Descriptive Statistics 26(a).3 Null Hypothesis and Alternative Hypothesis 26(a).4 Classifications of Data 26(a).5 Test of Hypothesis with the Correct Statistical Tests 26(a).6 Summary (b) Terminology Used in Biostatistics 26(b).1 Introduction to Biostatistics 26(b).2 Terminology used in Biostatistics 26(b).3 Sampling Unit Glossary" @default.
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- W1497465024 date "2013-01-29" @default.
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- W1497465024 title "A Practical Guide to Human Research and Clinical Trials" @default.
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