GUIDELINE FOR GOOD CLINICAL PRACTICE
INDEX
1.Introduction to Clinical Trials 3
2.Clinical Trial Protocol 5
3.International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 6
1.1.Introduction to GCP 6
1.2.Sections of GCP Guidelines 6
3.2.1.1Section 1- Glossary of various terms 6
3.2.1.2Section 2- Principles of ICH-GCP 7
3.2.1.3Section 3- Institutional Review Board/Independent Ethics Committee(IRB/IEC) 8
3.2.1.4Responsibilities 8
3.2.1.5Composition, Functions and Operations 8
3.2.1.6Procedures 8
3.2.1.7Records 8
3.2.1.8Section 4- Investigator 9
3.2.1.9Investigator's Qualifications and Agreements 9
3.2.1.10Adequate Resources 9
3.2.1.11Medical Care of Trial Subjects 9
3.2.1.12Communication with IRB/IEC 9
3.2.1.13Compliance with Protocol 9
3.2.1.14Investigational Product(s) 10
3.2.1.15Randomization Procedures and Unblinding 10
3.2.1.16Informed Consent of Trial Subjects 10
3.2.1.17Records and Reports 10
3.2.1.18 Progress Reports 10
3.2.1.19 Safety Reporting 11
3.2.1.20 Premature Termination or Suspension of a Trial 11
3.2.1.21 Final Report(s) by Investigator 11
3.2.1.22Section 5- Sponsor 11
3.2.1.23Quality Assurance and Quality Control 12
3.2.1.24Contract Research Organization (CRO) 12
3.2.1.25Medical Expertise 12
3.2.1.26Trial Design 12
3.2.1.27Trial Management, Data Handling, and Record Keeping 12
3.2.1.28Investigator Selection 13
3.2.1.29Allocation of Responsibilities 13
3.2.1.30Compensation to Subjects and Investigators 13
3.2.1.31Financing 13
3.2.1.32 Notification/Submission to Regulatory Authority 13
3.2.1.33 Confirmation of Review by IRB/IEC 13
3.2.1.34 Information on Investigational Product 14
3.2.1.35 Manufacturing, Packaging, Labelling, and Coding Investigational Product 14
3.2.1.36 Supplying and Handling Investigational Product(s) 14
3.2.1.37 Record Access 15
3.2.1.38 Safety Information 15
3.2.1.39 Adverse Drug Reaction Reporting 15
3.2.1.40 Monitoring 15
3.2.1.41Audit 16
3.2.1.42
1.Introduction to Clinical Trials 3
2.Clinical Trial Protocol 5
3.International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 6
1.1.Introduction to GCP 6
1.2.Sections of GCP Guidelines 6
3.2.1.1Section 1- Glossary of various terms 6
3.2.1.2Section 2- Principles of ICH-GCP 7
3.2.1.3Section 3- Institutional Review Board/Independent Ethics Committee(IRB/IEC) 8
3.2.1.4Responsibilities 8
3.2.1.5Composition, Functions and Operations 8
3.2.1.6Procedures 8
3.2.1.7Records 8
3.2.1.8Section 4- Investigator 9
3.2.1.9Investigator's Qualifications and Agreements 9
3.2.1.10Adequate Resources 9
3.2.1.11Medical Care of Trial Subjects 9
3.2.1.12Communication with IRB/IEC 9
3.2.1.13Compliance with Protocol 9
3.2.1.14Investigational Product(s) 10
3.2.1.15Randomization Procedures and Unblinding 10
3.2.1.16Informed Consent of Trial Subjects 10
3.2.1.17Records and Reports 10
3.2.1.18 Progress Reports 10
3.2.1.19 Safety Reporting 11
3.2.1.20 Premature Termination or Suspension of a Trial 11
3.2.1.21 Final Report(s) by Investigator 11
3.2.1.22Section 5- Sponsor 11
3.2.1.23Quality Assurance and Quality Control 12
3.2.1.24Contract Research Organization (CRO) 12
3.2.1.25Medical Expertise 12
3.2.1.26Trial Design 12
3.2.1.27Trial Management, Data Handling, and Record Keeping 12
3.2.1.28Investigator Selection 13
3.2.1.29Allocation of Responsibilities 13
3.2.1.30Compensation to Subjects and Investigators 13
3.2.1.31Financing 13
3.2.1.32 Notification/Submission to Regulatory Authority 13
3.2.1.33 Confirmation of Review by IRB/IEC 13
3.2.1.34 Information on Investigational Product 14
3.2.1.35 Manufacturing, Packaging, Labelling, and Coding Investigational Product 14
3.2.1.36 Supplying and Handling Investigational Product(s) 14
3.2.1.37 Record Access 15
3.2.1.38 Safety Information 15
3.2.1.39 Adverse Drug Reaction Reporting 15
3.2.1.40 Monitoring 15
3.2.1.41Audit 16
3.2.1.42