Clinical Trial Agreement Format

Clinical Trial Agreement Format

The disability or inapplicability of a clause or provision does not affect all of the other observations listed in this clinical trial agreement. In the event that any clause is found to be unenforceable or invalid, all other conditions remain fully in force. In the case of multi-centre research, if clinical trial agreements have been reached, at least one clinical trial agreement is required for the review of research records. This is the benchmark agreement for clinical trials. A written declaration from the promoter is sufficient for the other Dutch centres. The statement indicates that the clinical trial agreements for the other centres are similar to those of the clinical trial agreement on the two aspects reviewed by the Review Committee. If such a declaration is not included, clinical trial agreements for all participating centres must be submitted. PandaTip: This section of the model clearly defines the process of cancelling the clinical trial agreement. New inventions or discoveries, which are developed exclusively by experimentation, are considered royalties and are made available to all participating parties as such. The promoter undertakes not to make liable all parties who have entered into this agreement any debt resulting from improper packaging, documentation or transfer of objects related to the study in question. If legal procedures are followed at no time due to the lack of FDA sponsor guidelines will not be responsible for the procedure. The sponsor has adequate insurance coverage, as is required for these trials, and will retain insurance coverage for the remainder of the trail period. Members participating in this agreement may, at any time, request proof of assurance if deemed necessary.

PandaTip: This section is the standard for clinical trial agreements and describes the responsibilities of the parties involved in monitoring and reporting changes to the protocol. This study agreement can only be amended by the mutual written agreement of the authorized representatives of all members who are currently included in this clinical trial agreement.


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