Best Practices for Clinical Trial Sites

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 â" 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