Skip to main content

Table 2 Overview of sponsor’s specific responsibilities in the international GCP codes

From: Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

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