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Best Practices for Clinical Trial Sites

A Commonsense Approach to Clinical Research Operations, Quality and Compliance

AvA. M. Flores

Häftad, Engelska, 2026

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Beskrivning

The author shares their extensive knowledge of clinical trials operations, research compliance and quality assurance with individuals interested in pursuing a career in providing access to clinical trials to patients as part of medical care. Well-designed and -conducted clinical trials are our best chance to develop safe and effective treatments. Building a successful clinical trials program is important in order to evaluate new treatments and provide access to the community. In turn, novel treatments can be brought to the market in an efficient manner. This manual describes the different aspects of clinical trial investigator sites to assist in conducting clinical trials in compliance with all applicable laws, regulations, standards and guidance. It includes a selection of essential templates to assist in operational efficiency.Key FeaturesDiscussion of legal and regulatory intentBest practice approach to clinical research complianceSource and essential document templatesManual for entry-level as well as experienced clinical research professionalsPotential to serve as textbook for clinical trial formal training programs

Produktinformation

Utgivningsdatum:2026-09-17
Mått:210 x 280 x undefined mm
Vikt:540 g
Format:Häftad
Språk:Engelska
Antal sidor:278
Förlag:Taylor & Francis Ltd
ISBN:9781041348801

Utforska kategorier

Medicinsk utrustning och medicinska tekniker inom Medicin
Farmakologi inom Medicin
Tillverkningsteknik inom Naturvetenskap och teknik

Mer om författaren

Dr. A. M. Flores is a healthcare professional with over 40 years of experience. She is a licensed pharmacist and was awarded a PhD in pharmacology and toxicology with emphasis in drug metabolism and chemical carcinogenesis. For over 25 years, she has conducted/supported clinical trials in a variety of areas (oncology, cardiology, neurology, gastroenterology, bariatrics, pediatrics, and others) with an emphasis in patient safety, operations, quality, and regulatory compliance. She is a Certified Clinical Research Professional (CCRP-SoCRA), Project Management Professional (PMP-PMI), Agile Project Manager (PMI-ACP), and Certified in Healthcare Research Compliance (CHRC-HCCA), Certified in Healthcare Compliance (CHC-HCCA), Certified in Health Privacy Compliance (CHPC-HCCA), is a Certified Compliance & Ethics Professional (CCEP-SCCE) and is a Registered Quality Assurance Professional in Good Clinical Practice (RQAP-GCP/SQA). She is a speaker at national meetings and consults in areas of healthcare and clinical research operations, project management, healthcare and research compliance and quality assurance.

Innehållsförteckning

DEDICATION. ABBREVIATIONS. INTRODUCTION. CLINICAL TRIALS LAWS AND REGULATIONS. GOOD CLINICAL PRACTICES (GCP) ICH-E6(R3). THE CLINICAL TRIAL TEAM. CLINICAL TRIALS. CLINICAL TRIAL DEVELOPMENT PROCESS. GOOD DOCUMENTATION PRACTICES (GDP). ELEMENTS OF A CLINICAL TRIAL PROTOCOL. SITE QUALIFICATION PROCEDURES. INSTITUTIONAL REVIEW BOARDS (IRB). INFORMED CONSENT. CLINICAL TRIALS PROJECT MANAGEMENT. SITE INITIATION AND SITE INITIATION VISIT (SIV) PROCEDURES. SAFETY (AE, SAE, SUSAR, UADE, ADR). MEDWATCH. DEVIATIONS AND VIOLATIONS. PRIVACY AND CONFIDENTIALITY. INVESTIGATIONAL DRUG SERVICES. INVESTIGATIONAL DRUG COMPOUNDING VS. MANUFACTURING. CLINICAL LABORATORY SERVICES. DATA MANAGEMENT. CLINICAL TRIAL MONITORING. BIOSAFETY. CONFLICTS OF INTEREST. INVESTIGATOR SITE FILE. RISK MANAGEMENT. PROCESS MAPPING. CLINICALTRIALS.GOV. INVESTIGATOR DRUG BROCHURE. COVERAGE ANALYSES, BUDGETS AND BILLING COMPLIANCE. CLINICAL TRIAL AGREEMENTS. INVESTIGATIONAL NEW DRUG APPLICATION. SPONSOR-INVESTIGATOR INVESTIGATIONAL NEW DRUG (IND) PROCEDURES. DATA AND SAFETY MONITORING COMMITTEES. MEDICAL DEVICES. HUMANITARIAN USE DEVICES. FDA INSPECTION PREPARATION. CAPA PLANS AND RCAS. DECENTRALIZED CLINICAL TRIALS. RESEARCH INTEGRITY AND MISCONDUCT. TECHNOLOGY. FORM TEMPLATES LIBRARY. ADVERSE EVENT TRACKING LOG TEMPLATE. CALIFORNIA HEALTH & SAFETY CODE '24172. CORRECTIVE AND PREVENTIVE ACTION PLAN. CLINICAL TRIAL FEASIBILITY CHECKLIST TEMPLATE. CONCOMITANT MEDICATION TRACKING LOG. DELEGATION OF AUTHORITY LOG. EXTERNAL AUDIT TRACKER. LETTER OF ATTESTATION. GENERAL DATA PROTECTION REGULATION. CLINICAL TRIALS EDUCATION GENERAL TRAINING LOG. INFORMED CONSENT DOCUMENT TEMPLATE REVIEW. FEDERALLY-FUNDED CLINICAL TRIALS. INFORMED CONSENT DOCUMENT TEMPLATE REVIEW. NON-FEDERALLY-FUNDED CLINICAL TRIALS. INFORMED CONSENT PROCESS VERIFICATION TEMPLATE. INTERNAL AUDIT TRACKER. INTERNAL GCP REVIEW CHECKLIST. INVESTIGATIONAL MEDICINAL PRODUCT ACCOUNTABILITY LOG - NON-INJECTABLES. INVESTIGATIONAL MEDICINAL PRODUCT ACCOUNTABILITY LOG - INJECTABLES. INVESTIGATIONAL MEDICINAL PRODUCT ACCOUNTABILITY LOG. INVESTIGATIONAL MEDICAL DEVICE ACCOUNTABILITY LOG. INVESTIGATIONAL MEDICINAL PRODUCT (IMP) RETURN LOG. EXAMPLE INVESTIGATOR SITE FILE. INVESTIGATOR SITE FILE CONTENTS. INVESTIGATOR SITE FILE – DOCUMENT FILING GUIDELINES. MEDICARE COVERAGE ANALYSIS TEMPLATE. MONITOR VISIT CODE OF CONDUCT. NOTE TO FILE. REGULATORY INSPECTIONS TRACKER. RESEARCH CONFLICTS OF INTEREST DISCLOSURE STATEMENT. ROOT CAUSE ANALYSIS REPORT. SERIOUS ADVERSE EVENT (SAE) REPORTING FORM. SHARPS INJURY LOG. SCREENING VISIT VERIFICATION WORK FLOW. SITE INITIATION VISIT PREPARATION CHECKLIST. CLINICAL TRIALS EDUCATION TRAINING LOG. SITE CLOSEOUT CHECKLIST. PRE-SCREENING AND RECRUITMENT LOG. CLINICAL TRIAL ENROLLMENT AND SCREENING LOG. PROTOCOL VIOLATION/ PROCESS DEVIATION REPORT FORM. VIOLATION AND DEVIATION TRACKING LOG. STANDARD OPERATING PROCEDURE TEMPLATE. STATE REQUIREMENTS FOR LEGALLY AUTHORIZED REPRESENTATIVE INFORMATION

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