Best Practices for Clinical Trial Sites A Commonsense Approach to Clinical Research Operations, Quality and Compliance

DEDICATION
PREFACE
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: MANDATORY AND VOLUNTARY REPORTING OF SIDE EFFECTS
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
INTERNAL AUDIT TRACKER
INTERNAL GCP REVIEW CHECKLIST
INVESTIGATIONAL MEDICINAL PRODUCT ACCOUNTABILITY LOG
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
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

Biography

Dr. Aurea M. Flores is a healthcare professional with over 40 years of experience. She is a licensed pharmacist and was awarded a PhD in Pharmacology & 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.