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A Sponsor of a clinical trial is responsible for many aspects of clinical trial conduct, which includes:A. Maintaining the clinical trial master file.B. Supplying and disposing of Investigational Drug.C. Ensuring the Investigators are conducting the trial according to the protocol.D. A, B, and C.

Question

A Sponsor of a clinical trial is responsible for many aspects of clinical trial conduct, which includes:A. Maintaining the clinical trial master file.B. Supplying and disposing of Investigational Drug.C. Ensuring the Investigators are conducting the trial according to the protocol.D. A, B, and C.

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Solution

The correct answer is D. A, B, and C.

A sponsor of a clinical trial is indeed responsible for all the aspects mentioned:

A. Maintaining the clinical trial master file: This is a collection of all the essential documents which allows the conduct of a clinical trial and the quality of the data produced to be evaluated.

B. Supplying and disposing of Investigational Drug: The sponsor is responsible for providing the drug that is being tested in the trial and for the proper disposal of any unused portions of the drug.

C. Ensuring the Investigators are conducting the trial according to the protocol: The sponsor must ensure that the trial is being conducted in accordance with the study protocol and all applicable laws and regulations. This includes monitoring the trial's progress and the data it produces.

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