Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance ICH April 1996Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance Additional copies are available from: the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training, and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448, http://www.fda.gov/cber/guidelines.htm (Fax) 888-CBERFAX or 301-827-3844 (Voice Information) 800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 1996 ICHTable of Contents INTRODUCTION ..........................................................1 1. GLOSSARY .........................................................1 2. THE PRINCIPLES OF ICH GCP .........................................8 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) ..........................................................10 3.1 Responsibilities .................................................10 3.2 Composition, Functions, and Operations ..............................11 3.3 Procedures ....................................................12 3.4 Records ......................................................13 4. INVESTIGATOR ....................................................13 4.1 Investigator's Qualifications and Agreements ..........................13 4.2 Adequate Resources .............................................14 4.3 Medical Care of Trial Subjects .....................................14 4.4 Communication with IRB/IEC .....................................15 4.5 Compliance with Protocol ........................................15 4.6 Investigational Product(s) .........................................16 4.7 Randomization Procedures and Unblinding ............................16 4.8 Informed Consent of Trial Subjects ..................................17 4.9 Records and Reports ............................................21 4.10 Progress Reports ...............................................22 4.11 Safety Reporting ................................................22 4.12 Premature Termination or Suspension of a Trial ........................23 4.13 Final Report(s) by Investigator/Institution .............................23 5. SPONSOR ..........................................................24 5.1 Quality Assurance and Quality Control ...............................24 5.2 Contract Research Organization (CRO) ..............................24 5.3 Medical Expertise ...............................................24 5.4 Trial Design ...................................................25 5.5 Trial Management, Data Handling, Recordkeeping, and Independent Data Monitoring Committee ...........................................25 5.6 Investigator Selection ............................................27 5.7 Allocation of Duties and Functions ..................................27 5.8 Compensation to Subjects and Investigators ...........................28 5.9 Financing .....................................................28 5.10 Notification/Submission to Regulatory Authority(ies) ....................28 i5.11 Confirmation of Review by IRB/IEC ................................28 5.12 Information on Investigational Product(s) .............................29 5.13 Manufacturing, Packaging, Labeling, and Coding Investigational ...........29 5.14 Supplying and Handling Investigational Product(s) ......................30 5.15 Record Access .................................................31 5.16 Safety Information ..............................................31 5.17 Adverse Drug Reaction Reporting ..................................31 5.18 Monitoring ....................................................32 5.19 Audit ........................................................36 5.20 Noncompliance .................................................37 5.21 Premature Termination or Suspension of a Trial ........................37 5.22 Clinical Trial/Study Reports .......................................37 5.23 Multicenter Trials ...............................................37 6. CLINICAL TRIAL PROTOCOL AND PROTOCOL .........................38 6.1 General Information .............................................38 6.2 Background Information ..........................................39 6.3 Trial Objectives and Purpose ......................................39 6.4 Trial Design ...................................................39 6.5 Selection and Withdrawal of Subjects ................................40 6.6 Treatment of Subjects ............................................40 6.7 Assessment of Efficacy ...........................................41 6.8 Assessment of Safety ............................................41 6.9 Statistics ......................................................41 6.10 Direct Access to Source Data/Documents .............................42 6.11 Quality Control and Quality Assurance ...............................42 6.12 Ethics ........................................................42 6.13 Data Handling and Recordkeeping ..................................42 6.14 Financing and Insurance ..........................................42 6.15 Publication Policy ...............................................42 6.16 Supplements ...................................................42 7. INVESTIGATOR'S BROCHURE ........................................42 7.1 Introduction ...................................................42 7.2 General Considerations ...........................................43 7.3 Contents of the Investigator’s Brochure ..............................44 7.4 Appendix 1 ....................................................48 7.5 Appendix 2 ....................................................49 8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL .....50 8.1 Introduction ...................................................50 8.2 Before the Clinical Phase of the Trial Commences ......................51 ii8.3 During the Clinical Conduct of the Trial