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Clinical Trial Agreement Requirements

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Clinical Trial Agreement Requirements

In addition, this section contains other agreements, such as the Sponsor`s right to regularly check the Website or verify data, and the Site`s responsibility to cooperate with the Sponsor or a regulatory authority such as the FDA. The CCMO believes that the clauses relating to the early termination of the study and their publication in these models are consistent with the CCMO Directive on the Evaluation of Clinical Trial Agreements. The payment terms and schedule also indicate what the search is not paid for. For example, for a post-authorisation clinical trial, the sponsor may not want to make the medical device available free of charge. Principal Investigators should discuss all aspects of the clinical trial prior to the start of negotiations with their contract manager. The involvement of the UCI faculty in the development of the protocol and/or the design of the studies creates additional problems that both parties must fully address. Therefore, different or additional contractual conditions must be negotiated. When negotiating clinical trial contracts, the university focuses primarily on ensuring acceptable contractual clauses on high-risk topics such as violations, indemnification, confidentiality, data ownership, patent rights, and publication rights. As a public assistance institution, the UCI must cover the full costs of research carried out for external sponsors, including all related operating costs (overheads). Otherwise, the for-profit research would be publicly funded. Overhead costs are the facilities and management fees (R&A) that are incurred to support the university`s research infrastructure. The university pools its overhead costs for simple accounting, as it is difficult to attribute these costs to a given project or program with a relative degree of accuracy. The Federal Government`s Office of Management and Budget sets the standards for calculating the indirect cost rate and the UCI regularly negotiates its rates with the audit authority of the US Department of Health.

The university deducts its overhead rate for clinical trials from the applicable components of the state-approved rate. This section of the agreement is often overlooked by sponsors, CROs, and sites. The purpose of this section is to explicitly indicate the description of the research project. You would like to document the overall purpose of the agreement in this section. In the case of multi-centre research, clinical trial agreements require at least one clinical trial agreement for verification of the research record. This is the reference agreement for clinical trials. For other Dutch centres, a written declaration from the sponsor is sufficient. The statement states that the clinical trial agreements concluded for the other centres are similar to the reference agreement for clinical trials with regard to the two aspects examined by the Review Committee. . . .