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but they must be resolved before the contract can be signed. Anyone who has contracted for a study with the prestigious universities and medical schools on the U.S. East Coast will understand the dialogue which can ensue following a minor disagreement about a contract. The signature on the contract must be appropriately chosen, as it will be considered legally binding by the CRO. Thus, it must be determined who within the sponsor has the authority to commit the company to a contract and at what level of funding. Although the effort is directed to drafting and agreeing on the contract, the CRO will be keen to start the preliminary activities needed if they are to meet the sponsor's deadlines. The sponsor will also want to see some progress. At this juncture, the possibility of issuing a letter of intent will be raised. It has to be understood that a letter of intent or even a comfort letter can be legally binding and should be issued with great care. However, when used prudently and with clear points stating what can be done under the letter of intent, it can be most useful. It should also be remembered that the authorization issue raised earlier applies to these letters in addition to the contracts. |
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A vital ingredient to ensuring the success for a contract is good, open, and honest communication between the CRO and the sponsor. During the CRO selection phase, a team within the sponsor will have been active in evaluating the bidding companies. Once the contract has been awarded or during the drafting, it is vital that those team members do not think that their job is done. A team must be maintained and must meet with their counterparts within the CRO at a frequency agreeable to both parties. It must be made clear to these staff that they have a continuing role to play and must devote time to the monitoring and management of the contract. All team members from the sponsor and CRO must be given defined roles and must clearly understand their responsibilities, accountabilities, and time schedules. It is good practice to nominate a point person within each company to act as a first contact when any issues are to be raised. A system of progress review must be agreed on and a reporting schedule confirmed. There are many opinions expressed as to the internal resource required of a sponsor to monitor and manage successfully a contracted study. This will depend on the scale and complexity of the study but has been put by some authorities as high as one-third of the staff resource employed on the contract by the CRO. This may be extreme, but it illustrates the importance of sponsor involvement even when studies are contracted out. There will be some areas where the sponsor will wish to issue and agree on written guidelines for the CRO to follow. Most notably, these will relate to reporting of serious adverse events; the flow of information, responsibility for action, |
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