CONDUCTING GCP-COMPLIANT CLINICAL RESEARCH
CHAPTER 1 FOUNDATIONAL ELEMENTS AND REGULATORY REQUIREMENTS 1 1 WHAT IS THE PURPOSE OF MEDICAL RESEARCH? 1 2 DEFINING THE TYPES OF RESEARCH STUDIES 1 3 MANDATORY REGULATIONS AND ICH GCP (INTERNATIONAL COUNCIL FOR HARMONISATION GOOD CLINICAL PRACTICE) ETHICAL GUIDELINES 1 4 HOW TO SECURE A CLINICAL TRIAL AND HOW TO MARKET YOUR MEDICAL FACILITY TO SPONSORS 1 5 PRINCIPAL INVESTIGATOR (PI) RESPONSIBILITIES 1 6 RESEARCH COORDINATOR (RC) RESPONSIBILITIES 1 7 UNDERSTANDING THE ROLE OF HIPAA AND PHI IN CLINICAL RESEARCH ENDNOTES CHAPTER 2 PREPARATION BEFORE A CLINICAL TRIAL BEGINS 2 1 CLINICAL TRIAL FEASIBILITY ANALYSIS 2 2 FINANCIAL CONFLICT OF INTEREST REGULATIONS IN A CLINICAL TRIAL 2 3 CONFIDENTIALITY DISCLOSURE AGREEMENT (ALSO KNOWN AS A NON-DISCLOSURE AGREEMENT) 2 4 THE CLINICAL TRIAL CONTRACT (ALSO KNOWN AS A CLINICAL SERVICES AGREEMENT/CSA OR A CLINICAL TRIAL AGREEMENT/CTA) 2 5 CONSENT FORMS AND DOCUMENTATION 2 5 1 WAIVER OR ALTERATION OF CONSENT 2 5 2 WAIVER OF DOCUMENTATION OF CONSENT 2 5 3 SHORT FORM CONSENT 2 5 4 ASSENT 2 6 THE CLINICAL TRIAL BUDGET 2 7 STUDY START-UP AND SPONSOR DOCUMENTATION REQUIREMENTS 2 8 THE MEDICARE COVERAGE ANALYSIS 2 9 HOW TO REGISTER A CLINICAL TRIAL AT WWW CLINICALTRIALS GOV 2 10 FLOWCHART FOR SEQUENCE/TIMING OF ALL TASKS IN THIS CHAPTER CHAPTER 3 RECRUITING CLINICAL RESEARCH SUBJECTS 3 1 ACTIVITIES PREPARATORY TO RESEARCH: IDENTIFYING AND/OR CONTACTING SUBJECTS FOR STUDY RECRUITMENT CONTENTS 3 2 INTRODUCTION TO RECRUITING SUBJECTS FOR A CLINICAL STUDY 3 2 1 METHODS FOR RECRUITING SUBJECTS INTERNALLY 3 3 METHODS FOR RECRUITING SUBJECTS EXTERNALLY 3 4 EXTERNAL SUBJECT RECRUITING STRATEGIES INVOLVING DIRECT MEDIA 3 5 FDA GUIDANCE GOVERNING DIRECT ADVERTISING CHAPTER 4 CLINICAL TRIAL CONDUCT—A DAILY PERSPECTIVE 4 1 HIPAA (HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT) AND DE-IDENTIFIED CHART REVIEWS AND DATABASES 4 2 TRANSLATION AND INTERPRETATION 4 3 BLINDING AND UNBLINDING IN A CLINICAL TRIAL 4 4 ADVERSE EVENTS AND REPORTING IN A CLINICAL TRIAL 4 5 THE VARIOUS FORMS USED IN A CLINICAL TRIAL 4 5 1 DELEGATION OF AUTHORITY (DOA)/DELEGATION OF RESPONSIBILITY 4 6 PROJECT MANAGEMENT FOR CLINICAL TRIALS 4 7 CODING FOR CLINICAL TRIAL CLAIMS 4 8 CHOOSING A CTMS CHAPTER 5 ORGANIZATIONS WITH OVERSIGHT RESPONSIBILITY IN CLINICAL RESEARCH 5 1 THE INSTITUTIONAL REVIEW BOARD 5 2 THE CENTRAL INSTITUTIONAL REVIEW BOARD 5 3 DATA SAFETY MONITORING BOARD, ALSO KNOWN AS THE DATA MONITORING COMMITTEE 5 4 CLINICAL ENDPOINT COMMITTEE 5 5 ASSOCIATION FOR THE ACCREDITATION OF HUMAN RESEARCH PROTECTION PROGRAMS, INC 5 6 WHAT YOU NEED TO KNOW ABOUT FDA INSPECTIONS, COMPLIANCE, & ENFORCEMENT CHAPTER 6 EXCEPTIONAL CIRCUMSTANCES IN CLINICAL RESEARCH 6 1 EXPANDED ACCESS (COMPASSIONATE USE) 6 2 CHARGING FOR AN INVESTIGATIONAL NEW DRUG IN A CLINICAL TRIAL 6 3 EMERGENCY USE OF A TEST ARTICLE 6 4 RESEARCH ON DECEDENTS AND PHI IN CLINICAL RESEARCH 6 5 VULNERABLE POPULATIONS 6 6 LEGALLY AUTHORIZED REPRESENTATIVE AND WITNESS 6 7 WHAT TO DO WHEN A PI DEPARTS FROM A STUDY OR INSTITUTION 6 8 CONSEQUENCES OF CLINICAL RESEARCH NON-COMPLIANCE AND HOW TO RESPOND TO NON-COMPLIANCE CHAPTER 7 EDUCATION AND CERTIFICATION IN CLINICAL RESEARCH 7 1 BACHELORS AND MASTERS DEGREE PROGRAMS IN CLINICAL RESEARCH 7 2 CERTIFICATION ORGANIZATIONS 7 3 TRAINING REQUIREMENTS FOR PERSONNEL CONDUCTING CLINICAL TRIALS CHAPTER 8 THE NEWEST CHANGES IN CLINICAL RESEARCH 8 1 HUMAN SUBJECTS PROTECTION: ACCEPTANCE OF DATA FROM CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES 8 2 THE NEW COMMON RULE 8 3 PAYMENT AND REIMBURSEMENT TO RESEARCH SUBJECTS 8 4 THE SINGLE INSTITUTIONAL REVIEW BOARD (SIRB) 8 5 NEW CHANGES TO CERTIFICATES OF CONFIDENTIALITY 8 6 NEW ICH GCP E6 R2 (REVISION 2) GUIDELINES 8 7 ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD) 8 8 NEW CHANGES IN CLINCIALTRIALS GOV REGISTRATION AND REPORTING CHAPTER 9 AFTER THE STUDY HAS ENDED 9 1 STUDY CLOSEOUT 9 2 ESSENTIAL DOCUMENTS AND REGULATIONS FOR DOCUMENT RETENTION IN CLINICAL RESEARCH 9 3 PUBLISHING THE RESULTS OF A CLINICAL RESEARCH STUDY