Table 2 Overview of sponsor’s specific responsibilities in the international GCP codes
WHO GCP 1995 | ICH GCP 1996 |
|---|---|
5.1 Selection of the Investigator(s) | 5.1 Quality Assurance and Quality Control |
5.2 Delegation of responsibilities | 5.2 Contract Research Organization |
5.3 Compliance with the protocol and procedures | 5.3 Medical Expertise |
5.4 Product information | 5.4 Trial Design |
5.5 Safety information | 5.5 Trial Management, Data Handling, and Record Keeping |
5.6 Investigational product | 5.6 Investigator Selection |
5.7 Trial management and handling of data | 5.7 Allocation of Responsibilities |
5.8 Standard operating procedures | 5.8 Compensation to Subjects and Investigators |
5.9 Compensation for subjects and investigators | 5.9 Financing |
5.10 Monitoring | 5.10 Notification/Submission to Regulatory Authority(ies) |
5.11 Quality assurance | 5.11 Confirmation of Review by IRB/IEC |
5.12 Study reports | 5.12 Information on Investigational Product(s) (IPs) |
5.13 Handling of adverse events | 5.13 Manufacturing, Packaging, Labelling, and Coding IP(s) |
5.14 Termination of the trial | 5.14 Supplying and Handling IP(s) |
5.15 Record Access | |
5.16 Safety Information | |
5.17 Adverse Drug Reaction Reporting | |
5.18 Monitoring | |
5.19 Audit | |
5.20 Noncompliance | |
5.21 Premature Termination or Suspension of a Trial | |
5.22 Clinical Trial/Study Reports | |
5.23 Multicenter Trials |