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close this bookGuidelines for good clinical practice (GCP) for trials on pharmaceutical products (WHO Technical Report Series, No. 850, 1995, Annex 3) (WHO, 1995, 36 p.)
close this folder5. RESPONSIBILITIES OF THE SPONSOR
View the document(introductory text...)
View the document5.1 Selection of the investigator(s)
View the document5.2 Delegation of responsibilities
View the document5.3 Compliance with the protocol and procedures
View the document5.4 Product information
View the document5.5 Safety information
View the document5.6 Investigational product
View the document5.7 Trial management and handling of data
View the document5.8 Standard operating procedures
View the document5.9 Compensation for subjects and investigators
View the document5.10 Monitoring
View the document5.11 Quality assurance
View the document5.12 Study reports
View the document5.13 Handling of adverse events
View the document5.14 Termination of trial

5.9 Compensation for subjects and investigators

As required by national law or regulations, the sponsor should provide adequate compensation or treatment for subjects in the event of trial-related injury or death, and provide indemnity for the investigator, except in the case of claims resulting from malpractice and/or negligence. (See Section 3.2 (e)-(f)).