{"product_id":"a-practical-guide-to-human-research-and-clinical-trials-9781466591172","title":"A Practical Guide to Human Research and Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eRegulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, \u003cb\u003eA Practical Guide to Human Research and Clinical\u003c\/b\u003e focuses on ethics, regulations, and guidelines.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eConducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003eClinical Research – A Clinical Investigator’s Perspective\u003cbr\u003e\u003c\/strong\u003eIntroduction \u003cbr\u003eScientific and Practical Aspects \u003cbr\u003eFinancial Considerations\u003cbr\u003e\u003cbr\u003e\u003cb\u003eMedical Device Development, Process and Regulation\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eCategories of Medical Devices \u003cbr\u003eEvaluation of Medical Devices \u003cbr\u003eRegulatory Process \u003cbr\u003e\u003cbr\u003e\u003cb\u003ePre-Clinical Drug Development\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eOverview of Drug Discovery and Role of basic Sciences \u003cbr\u003eNew Approaches in Drug Discovery \u003cbr\u003ePharmacological Screening \u003cbr\u003e\u003cbr\u003e\u003cb\u003ePhases of Clinical Trials\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003ePhase I \u003cbr\u003ePhase II Studies \u003cbr\u003ePhase III Trials \u003cbr\u003ePhase IV Trials \u003cbr\u003e\u003cbr\u003ePhase 0 - Microdosing Studies\u003cbr\u003eIntroduction \u003cbr\u003eMicro-dosing and Exploratory-IND Studies\u003cbr\u003eCharacteristics of an Ideal Candidate Drug for Phase 0-Micro-dosing Studies \u003cbr\u003eGoals of Microdosing Studies\u003cbr\u003eTechnical Advances \u003cbr\u003eRegulatory Issues\u003cbr\u003ePatient’s Perspective\u003cbr\u003eInformed Consent Issues \u003cbr\u003eSingle-dose Toxicity Study in Support of Micro-dosing Studies\u003cbr\u003eAdvantages of Micro-dosing\u003cbr\u003eLimitations of Micro-dosing \u003cbr\u003eConclusion \u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Research Planning\u003cbr\u003e\u003c\/b\u003eIntroduction to Clinical Trials \u003cbr\u003eTypes of Clinical Trials\u003cbr\u003eThe Planning Steps\u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Research Design\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eElements of Trial Design\u003cbr\u003eTypes of Clinical Trial Design\u003cbr\u003e\u003ci\u003e\u003cbr\u003e\u003c\/i\u003e\u003cb\u003eClinical Research Protocol\u003cbr\u003e\u003c\/b\u003eTitle Page \u003cbr\u003eSignature Page\u003cbr\u003eContents Page \u003cbr\u003eList of Abbreviations and Definitions \u003cbr\u003eSummary \u003cbr\u003eBackground\u003cbr\u003eTrial Objectives and Purpose \u003cbr\u003eStudy Design\u003cbr\u003eSubject Selection \u003cbr\u003eSubject Recruitment \u003cbr\u003eTrial Interventions \u003cbr\u003eRandomisations \u003cbr\u003eBlinding \u003cbr\u003eData \u003cbr\u003eStatistical Considerations \u003cbr\u003eCompliance and Withdrawal \u003cbr\u003eInterim Analysis and Data Monitoring\u003cbr\u003eEthical Considerations \u003cbr\u003eFinancing and Insurance \u003cbr\u003eReporting and Publication \u003cbr\u003e\u003cbr\u003e\u003cb\u003eDesigning Case Report Forms\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eUses of CRF\u003cbr\u003eWell-Designed CRF \u003cbr\u003eCRF Design Layout \u003cbr\u003eCRF Field Designs \u003cbr\u003eCRF Verification Before Use \u003cbr\u003eElements of Trial Design \u003cbr\u003eElectronic Data Entry Forms \u003cbr\u003eConclusion \u003cbr\u003ePoints to Remember \u003cbr\u003e\u003cbr\u003eProcess of Randomization in Clinical Trials\u003cbr\u003eIntroduction \u003cbr\u003eAdvantages of Randomization \u003cbr\u003eTypes of Randomization \u003cbr\u003eTechniques of Randomisation \u003cbr\u003eImplementation of Randomization Procedure \u003cbr\u003e\u003cbr\u003e\u003cb\u003eInvestigational Medicinal Products\u003cbr\u003e\u003c\/b\u003eDefinition \u003cbr\u003eManufacturing, Packaging, Labeling, and Coding IMPs\u003cbr\u003eSupply and Handling IMPs \u003cbr\u003eReceipt of IMP, Inventory, Storage and Accountability \u003cbr\u003eRandomization Code \u003cbr\u003ePrinciples Applicable to Comparator Product \u003cbr\u003eBlinding Operations \u003cbr\u003eRecall, Return, Shipment and Destruction of IMP \u003cbr\u003e\u003cbr\u003e\u003cb\u003eMulti-center Clinical Trials\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eAdvantages and Disadvantages\u003cbr\u003eA Common Protocol \u003cbr\u003eA Coordinating Centre \u003cbr\u003eComparability of Participating institutions \u003cbr\u003eCommittees in a Multi-center Trial \u003cbr\u003eStatistical Issues \u003cbr\u003eAnalysis of Results \u003cbr\u003eMultinational Clinical Trials \u003cbr\u003e\u003ci\u003e\u003cbr\u003e\u003c\/i\u003e\u003cb\u003eGood Clinical Research Practice\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eDefinition of GCP\u003cbr\u003eOverview of the Clinical Research Process \u003cbr\u003ePrinciples of GCP\u003cbr\u003e\u003cbr\u003e\u003cb\u003eRole and Responsibilities of Sponsor\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eContract Research Organization (CRO) \u003cbr\u003eThe Sponsor and the investigational Products \u003cbr\u003eSponsor and Record Access \u003cbr\u003eSafety Information \u003cbr\u003e\u003cbr\u003e\u003cb\u003eRole and Responsibilities of Principal Investigator\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eCompetencies and Responsibilities of the Principal Investigator \u003cbr\u003eQualifications and Availability \u003cbr\u003eAdequate Resources \u003cbr\u003eInformed Consent \u003cbr\u003eInvestigational Products \u003cbr\u003eCompliance with Protocol \u003cbr\u003eMonitoring and Auditing \u003cbr\u003eSource Data and Other Documentation \u003cbr\u003eSafety Issues and Reporting of Serious Adverse Events \u003cbr\u003ePremature Termination - Breaking the Treatment Code \u003cbr\u003eProgress Reports, Trial Outcome and Final Study Reports \u003cbr\u003e\u003cbr\u003e\u003cb\u003eEthical Consideration in Clinical Research – Special Reference to Developing Countries\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eIndividuals Involved With Ethical Issues \u003cbr\u003eEthical Issues Related to Protocol Development and Study Design\u003cbr\u003eIssues on Informed Consent \u003cbr\u003eEthical Issues During Conduct of a Clinical Research \u003cbr\u003eAccess to Post Trial Benefits \u003cbr\u003eNeed for Developed Countries to Assist Developing\u003cbr\u003eCountries in Capacity Building \u003cbr\u003e\u003cbr\u003e\u003cb\u003eInformed Consent in Clinical Research\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eHistorical Background \u003cbr\u003eElements of Informed Consent \u003cbr\u003eLanguage Used in Consent Forms \u003cbr\u003eInformed Consent Waiver \u003cbr\u003eRevising an Informed Consent\u003cbr\u003eReconsenting Process \u003cbr\u003eConsent Obtained from Special Groups of Patients \u003cbr\u003e\u003cbr\u003e\u003cb\u003eMonitoring in Clinical Trials\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eTypes of Monitoring in Clinical Trials \u003cbr\u003eKey Participant in Monitoring of Clinical Trial \u003cbr\u003e\u003cbr\u003e\u003cb\u003eQuality Assurance in Clinical Research\u003cbr\u003e\u003c\/b\u003eMonitoring-Details Presented in Chapter on Monitoring \u003cbr\u003eAudit \u003cbr\u003eInspections \u003cbr\u003eData Management Metrics \u003cbr\u003e\u003cbr\u003e\u003cb\u003ePharmacovigilance and Drug Safety\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eTerms Commonly Used in Drug Safety \u003cbr\u003eThe Specific Aims of Pharmacovigilance \u003cbr\u003eDefinitions \u003cbr\u003eADR Classification and Evolution \u003cbr\u003eCausality Assessment Scales \u003cbr\u003eImportant of Post Marketing Surveillance and ADR Reporting \u003cbr\u003eCharacteristics of a Good Adverse Drug Reaction Report \u003cbr\u003ePeriodic Safety Update Report (PSUR) \u003cbr\u003eMedDRA or Medical Dictionary for Regulatory Activities \u003cbr\u003ePharmacovigilance in India \u003cbr\u003e\u003cbr\u003e\u003cb\u003eData and Safety Monitoring Board and Monitoring Plan\u003cbr\u003e\u003c\/b\u003eDefinition and Purpose \u003cbr\u003eData Monitoring Committee \u003cbr\u003eData Safety Monitoring Plan \u003cbr\u003e\u003cbr\u003e\u003cb\u003eStandard Operating Procedures\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eStandard Operating Procedures \u003cbr\u003eSOP Template \u003cbr\u003eMaster Formulation Record \u003cbr\u003e\u003cbr\u003e\u003cb\u003eArchiving Clinical Research Documents\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eStake Holders \u003cbr\u003eWhat Documents Must Be Archived \u003cbr\u003eHow long Should the Documents be Archived \u003cbr\u003eWhen to Archive Trail Master File (TMF) \u003cbr\u003eThe Archive Building\u003cbr\u003e\u003cbr\u003e\u003cb\u003eEvidence Based Medicine\u003cbr\u003e\u003c\/b\u003eIntroduction and Overview \u003cbr\u003eHistory \u003cbr\u003eTypes of EBM \u003cbr\u003eCategories of Evidence \u003cbr\u003eCategories of Recommendations \u003cbr\u003eStatistical Measures \u003cbr\u003eQuality of Clinical Trial Publications \u003cbr\u003eLimitations of Available Evidence \u003cbr\u003eCriticism of Evidence-Based Medicine \u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Research Data Management\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eProtocol \u003cbr\u003eRandomisation \u003cbr\u003eData Management \u003cbr\u003eFinal Study Report \u003cbr\u003eRetension and Securing of Records \u003cbr\u003eArchiving by the Principle Investigator \u003cbr\u003eArchiving by the Sponsor \u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Biostatistics\u003cbr\u003e\u003c\/b\u003e(a) Biostatistics for Clinical Researcher\u003cbr\u003e26(a).1 Introduction\u003cbr\u003e26(a).2 Descriptive Statistics \u003cbr\u003e26(a).3 Null Hypothesis and Alternative Hypothesis \u003cbr\u003e26(a).4 Classifications of Data \u003cbr\u003e26(a).5 Test of Hypothesis with the Correct Statistical Tests \u003cbr\u003e26(a).6 Summary \u003cbr\u003e(b) Terminology Used in Biostatistics\u003cbr\u003e26(b).1 Introduction to Biostatistics \u003cbr\u003e26(b).2 Terminology used in Biostatistics \u003cbr\u003e26(b).3 Sampling Unit \u003cbr\u003e\u003cbr\u003eGlossary \u003cbr\u003e\u003c\/p\u003e","brand":"Taylor \u0026 Francis Inc","offers":[{"title":"Default Title","offer_id":52090911588695,"sku":"9781466591172","price":104.5,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781466591172.jpg?v=1762273752","url":"https:\/\/bookcurl.com\/products\/a-practical-guide-to-human-research-and-clinical-trials-9781466591172","provider":"Book Curl","version":"1.0","type":"link"}