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agers generally must review the completed case record forms, resolve queries through the support of the clinical monitors, and build study databases for statistical analysis, it may be ideal to train monitors and data managers simultaneously. |
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B.
Actions Within the Sponsor |
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One of the major problems encountered frequently following the decision to award a contract to a particular CRO is the negotiation of the contract and the question of a letter of intent. It should be remembered that the contract between the sponsor and CRO consists of several distinct parts and the responsibility for compiling the parts rests with different people. The typical principal Terms and Conditions of a contract and those responsible for their completion are listed below: |
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definition and performance of services |
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data, publication, and intellectual property |
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compensation and indemnity |
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Under each of the major headings are several subheadings which need expert legal input. For example, under the heading of confidentiality are clauses on the definition of confidentiality, nondisclosure, return of confidential materials, terms of the obligation, and disclosure and ownership of intellectual property. Because of the importance of the legal contract, most pharmaceutical companies ensure that their clinical research staff has available standard boiler plate sections covering the legally drafted sections of the contract. However, for those companies who do not have this facility, a contract should be drafted for them by companies which specialize in pharmaceutical contracting. It is also useful to append the detailed Price and Payment Schedule and Protocol and Procedures Manual to the Contract. There will be occasions when the CRO suggests that the sponsor use their contract. For those pharmaceutical companies which do not have a standard contract for these purposes, this can be an advantage and will save time. However, the contract must be reviewed by the company Legal Department or by an independent expert. Therein lies a problem. Legal consideration can take time and points raised may appear trivial, on occasion, |
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