NIP Traducciones médicas

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Protocolo de ensayo clínico (italiano-inglés)

On signing “the Protocol”, the Investigator has given his consent to conduct the Trial according to the terms of the Protocol.

It is specified that the present agreement is concluded to comply with the legal requirements which stipulate that biomedical investigations be conducted under the direction and supervision of a medical doctor of proven and appropriate experience.

In order to insure that the Sponsor and the Investigator have full knowledge of their obligations to each other, the Sponsor wishes to formally establish a Clinical Trial Agreement which specifies the obligations of the parties regarding the conduct of the Clinical Trials. This Agreement also specifies what the Investigator may expect of the Sponsor in terms of information and technical assistance.

Setting up and execution

The Investigator and the Sponsor undertake to comply with the final version of the Protocol as well as with possible amendments, signed by the two parties and approved by the ........ Ethics Committee. The Investigator undertakes to respect Good Clinical Practice.

The Protocol may only be modified after informing and obtaining the consent of the Sponsor as well as that of the........ Ethics Committee and the competent authorities.