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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.)
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

5.2 Delegation of responsibilities

The sponsor is responsible for agreeing with the investigator(s) on the allocation of protocol-related responsibilities, including data processing, breaking of the trial code, handling of statistics, preparation of trial reports, and preparation and submission of documentation to the ethics committee, the drug regulatory authority, and any other required review bodies. This agreement should be confirmed in writing (protocol, contract, or alternative document) prior to the trial.

The sponsor may transfer any or all clinical trial-related activities to a scientific body (commercial, academic, or other), or to a contract research organization (CRO). Any such transfer should be documented in writing.